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Glufosinate-ammonium Volume 1

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					                             ECBI/53/03 Add. 3




   Draft Assessment Report




GLUFOSINATE-AMMONIUM
           Volume 1




   Rapporteur Member State: Sweden
 Co-Rapporteur Member State: Germany



             December 2002
             December 2003
RMS: SE           -2-             December 2002
                                  December 2003
          GLUFOSINATE-AMMONIUM
             Volume 1 - Level 2
GLUFOSINATE-AMMONIUM




    Listing of endpoints
RMS: SE                                              -4-                                  December 2002
                                                                                          December 2003
                                         GLUFOSINATE-AMMONIUM
                                            Volume 1 - Level 2
2.1      Identity, Physical and Chemical Properties, Details of Uses, Further Information, and Proposed
         Classification and Labelling


Active substance (ISO Common Name)                         Glufosinate-ammonium
Function (e.g. fungicide)                                  Herbicide
Rapporteur Member State                                    Sweden
Co-rapporteur Member State                                 Germany


Identity (Annex IIA, point 1)
Chemical name (IUPAC)                                      ammonium(DL)-homoalanin-4-
                                                           yl(methyl)phosphinate
Chemical name (CA)                                         2-amino-4-(hydroxymethylphosphinyl)butanoic
                                                           acid, monoammonium salt
CIPAC No                                                   437
CAS No                                                     77182-82-2
EEC No (EINECS or ELINCS)                                  278-636-6
FAO Specification (including year of publication)
Minimum purity of the active substance as
manufactured (g/kg)                                        950g/kg
Identity of relevant impurities (of toxicological,
environmental and/or other significance) in the
active substance as manufactured (g/kg)
Molecular formula                                          C5H12NO4P.H3N
Molecular mass                                             198.19
Structural formula                                                     O                O
                                                                        P
                                                            H3C                             OH
                                                                       O -
                                                                                    NH
                                                                       NH +           2
                                                                          4



Physical-chemical properties (Annex IIA, point 2)
Melting point (state purity)                               215-218 C d (99.5 % pure)
Boiling point (state purity)                               n.a.

Temperature of decomposition                               245-305 C

Appearance (state purity)                                  Crystalline powder

Relative density (state purity)                            1.32

Surface tension                                            72.1 mN/m

Vapour pressure (in Pa, state temperature)                 <3.1x10-5 at 50 C

Henry’s law constant (Pa m 3 mol -1 )                      4.48x10-9
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                                         GLUFOSINATE-AMMONIUM
                                            Volume 1 - Level 2

Solubility in water (g/l or mg/l, state temperature)         pH 5.4: >500 g/l at 20 C
                                                             pH 7: >500 g/l at 20 C
                                                             pH 8.9: >500 g/l at 20 C
Solubility in organic solvents (mg/l, 20 C)                 Acetone < 0.25
                                                             Acetonitrile < 0.25
                                                             1,2-dichloroethane < 0.25
                                                             dimethyl sulfoxide 48.9
                                                             ethyl acetate < 0.25
                                                             n-heptane < 0.25
                                                             methanol 5730
                                                             p-xylene < 0.25
Partition co-efficient (log POW) (state pH and               pH 5: -3.77
temperature)                                                 pH 7: -4.01
                                                             pH 9: -4.07
Hydrolytic stability (DT50) (state pH and temperature)       pH 5: >300 days at all pH
                                                             mass balance >98%
                                                             pH 7: >300 days at all pH
                                                             mass balance >98%
                                                             pH 9: >300 days at all pH
                                                             mass balance >98%
Dissociation constant                                        PKa = 9.15+0.07 at 23 C
                                                             Calculated value 9.66+0.01
UV/VIS absorption (max.) (if absorption > 290 nm             Neutral: 193 nm, 382.02 L/mol*cm
                                                             291 nm, 3.12 L/mol*cm
state e at wavelength)                                       Acidic: 207.25 nm, 57.05 L/mol*cm
                                                             291 nm, 0.31 L/mol*cm
                                                             Alkaline: 216.75 nm, 108.67 L/mol*cm
                                                             291 nm, no absorption
                                                             Spectra pH-dependant.
                                                             Virtually no absorption over 200 nm
Photostability (DT50) (aqueous, sunlight, state pH)          Stable (Sterile water)
                                                             1.3-2.2 years in gravel-pit water
Quantum yield of direct phototransformation in               n.a.
water at wavelength > 290 nm
Flammability                                                 Not flammable
Explosive properties                                         Not explosive
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                                                                      GLUFOSINATE-AMMONIUM
                                                                         Volume 1 - Level 2
Summary of representative /intended uses

GAP for non-selective use in apple orchads

Product       Formulation     Content ai.                       Application                    Applications                   PHI
                              %              Method             Growth stage          Number                                  days
Basta         SL14            150 g/l        spray              44 and 14 days        2        First appl. 1.125 kg as/ha,    14
                                                                before harvest                 2nd appl. 0.75 kg as/ha
                                                                                               Interval between appl. 30
                                                                                               days
Basta         SL18            200 g/l        spray              44 and 14 days        2        First appl 1.5 kg as/ha, 2nd   14
                                                                before harvest                 appl. 1.0 kg as/ha Interval
                                                                                               between appl 30 days



GAP for non-selective use for desiccation and harvest aid
Product      Formulation       Content ai.                      Application                    Applications                   PHI
                               %              Method            Growth stage          Number                                  days
Basta        SL14              150 g/l        spray             See PHI               1        0.45 kg as/ha                  7-14
Basta        SL18              200 g/l        spray             See PHI               1        0.6 kg as/ha                   7-14


GAP for selective use in transformed maize
Product      Formulation       Content ai.                      Application                    Applications                   PHI
                               %             Method             Growth stage          Number                                  days
Liberty      SL14              200 g/l       Spray, splitting   Up to 4 leaf stage    2        0.8                            The PHI is covered
                                                                    BBCH 14                                                   by the application
                                                                 Up to 8 leaf stage            0.8                            conditions and/or by
                                                                    BBCH 18                                                   the remaining
                                                                                                                              growth period
                                                                                                                              between application
                                                                                                                              and subsequent use
                                                                                                                              of the crop (e.g.
                                                                                                                              harvest)
Classification and proposed labelling (Annex IIA, point 10)
with regard to physical/chemical data
with regard to toxicological data                             Toxic         R20/22; R48/22 ; R48/23; R61; R62
with regard to fate and behaviour data
with regard to ecotoxicological data                          Dangerous for the environment.         R 51/53
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                                        GLUFOSINATE-AMMONIUM
                                           Volume 1 - Level 4
2.2      Methods of Analysis


Analytical methods for the active substance (Annex IIA, point 4.1)
Technical as (principle of method)                          HPLC / UV and HPLC / fluorescence detection
Impurities in technical as (principle of method)            Ammonium: Tot N Combustion
                                                            Chloride: Argentometric titr.
                                                            Acetate: IC
                                                            Methanol: GC
                                                            n-Butanol: GC
                                                            Water: Karl Fisher titr.
Plant protection product (principle of method)              HPLC / UV and HPLC / fluorescence detection


Analytical methods for residues (Annex IIA, point 4.2)
Food/feed of plant origin (principle of method and          GC; LOQ: 0.05 mg/kg
LOQ for methods for monitoring purposes)
Food/feed of animal origin (principle of method and         GC; LOQ: 0.05 mg/kg
LOQ for methods for monitoring purposes)
Soil (principle of method and LOQ)                          GC; LOQ: 0.05 mg/kg
Water (principle of method and LOQ)                         GC / MS; LOQ: 0.05 μg/l
Air (principle of method and LOQ)                           GC / MS; LOQ: 5 μg/m3
Body fluids and tissues (principle of method and            Not presented
LOQ)
RMS: SE                                             -9-                                    December 2002
                                                                                           December 2003
                                        GLUFOSINATE-AMMONIUM
                                           Volume 1 - Level 4
2.3      Impact on Human and Animal Health

Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)
 Rate and extent of absorption:                      Rapid (maximum blood concentration within 0.5 to 1 hr
                                                     after administration) but low (ca. 10% absorption across
                                                     all studies)
 Distribution:                                       Highest levels in kidney and liver
 Potential for accumulation:                         None
 Rate and extent of excretion:                       > 95% within 96 hours
 Metabolism in animals                               In all species tested, glufosinate ammonium (GA) is
                                                     primarily metabolised through oxidative de-amination
                                                     and decarboxylation to produce 3-methylphosphinco-
                                                     propionic acid (MPP). In addition, GA is reversibly
                                                     acetylated resulting in low levels of N-acetyl-glufosinate
                                                     (NAG).
 Toxicologically significant compounds (animals,     In plants and animals, GA, MPP and NAG.
 plants and environment)                             In the environment, GA.

Acute toxicity (Annex IIA, point 5.2)
 Rat LD50 oral                                       1510 mg/kg bw                                         R22
 Rat LD50 dermal                                     >2000 mg/kg bw                                    Class. ?
 Rat LC50 inhalation                                 1.26 mg/l                                             R20
 Skin irritation                                     Non-irritating
 Eye irritation                                      Non-irritating
 Skin sensitization (test method used and result)    Not a sensitizing agent (Buehler and maximization tests)

Short term toxicity (Annex IIA, point 5.3)
 Target / critical effect                            Clinical signs (sedation, lateral recumbency, hunched
                                                     posture, spasm, hyperactivity and lacrimation)
 Lowest relevant oral NOAEL / NOEL                   NOAEL 8.4 / NOEL 4.5 mg/kg bw/day                 R48/22
                                                     (1 yr dog)
 Lowest relevant dermal NOAEL / NOEL                 100 mg/kg bw/day (rat)
 Lowest relevant inhalation NOAEL / NOEL             0.012 mg/l (rat)                                   R48/23

Genotoxicity (Annex IIA, point 5.4)
                                                     Not genotoxic

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)
 Target/critical effect                              Mortality (mouse)
                                                     Increased kidney weight (rat)
 Lowest relevant NOAEL / NOEL                        NOAEL 11 mg/kg bw/day (mouse) / NOEL 2 mg/kg/d
                                                     (rat)
 Carcinogenicity                                     Not carcinogenic
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                                         GLUFOSINATE-AMMONIUM
                                            Volume 1 - Level 4
Reproductive toxicity (Annex IIA, point 5.6)
Reproduction target / critical effect                  Pre- and post-implantation losses, premature deliveries
                                                       and abortions
Lowest relevant reproductive NOAEL / NOEL              NOAEL 4.3 mg/kg bw/day (rat)                          R62
Developmental target / critical effect                 Premature deliveries, abortions and dead foetuses
Lowest relevant developmental NOAEL / NOEL             NOAEL 6.3 mg/kg bw/day (rabbit)                        R61

Neurotoxicity (Annex IIA, point 5.7)
Acute and repeat dietary neurotoxicity in rat          Single dose NOAEL 100 mg/kg bw

Delayed neurotoxicity: not relevant

Other toxicological studies (Annex IIA, point 5.8)
Metabolites NAG, MPP and MPA                           NAG is the major plant metabolite in glufosinate
                                                       ammonium (GA) tolerant crops. NAG is rapidly absorbed
                                                       and excreted in the rat. In vitro studies show that NAG
                                                       does not affect glutamine synthetase (GS). However, it
                                                       has been proven that in mammals, GA and NAG
                                                       interconvert; therefore, in in vivo studies, animals
                                                       administered NAG do show a level of GS inhibition
                                                       caused by de-acetylation to GA. NAG is of low acute
                                                       toxicity. It is not genotoxic or carcinogenic. NAG is not
                                                       teratogenic, nor does it adversely impact reproductive
                                                       performance. The lowest short term and long term
                                                       NOAELs are >> than those of parent GA.
                                                       MPP is the major plant metabolite in susceptible plants.
                                                       It is rapidly excreted in the rat. MPP is of low acute
                                                       toxicity and has no effect on GS in animals or
                                                       presumably plants. It is not genotoxic. MPP is not
                                                       teratogenic. The lowest short term NOAELs are >> than
                                                       those of parent GA.
                                                       MPA is an environmental metabolite. It results from
                                                       further degradation of MPP. It has been observed at low
                                                       levels in rat metabolism studies, presumably via MPP. It
                                                       is not acutely toxic. MPA is not genotoxic. The short
                                                       term toxicity profile is similar to its precursor MPP.

                                                       In conclusion, metabolites of GA are all less toxic than
                                                       parent compound. Therefore, use of GA toxicology
                                                       endpoints in risk assessments, which include levels of
                                                       metabolites, introduces an additional
                                                       conservatism/margin of safety.

Medical data (Annex IIA, point 5.9)
                                                       No adverse effects were reported in manufacturers or
                                                       operators during production of application of the product.

                                                       So far, clinical toxicological experience with glufosinate-
                                                       ammonium arises exclusively from suicidal cases and
                                                       very few incidences of accidental misuse of the herbicide
                                                       formulation. In all instances, intoxication occurred
                                                       exclusively with the formulated product. Almost all
                                                       attempts to commit suicide with glufosinate-ammonium
                                                       occurred in Japan. Initial effects seen are nausea,
                                                       vomiting and diarrhoea. Later neurological symptoms are
                                                       trembling, convulsions, coma and respiratory failure.
RMS: SE                                                  - 11 -                                       December 2002
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                                           GLUFOSINATE-AMMONIUM
                                              Volume 1 - Level 4

                                                           The therapy of Basta intoxications is strictly symptomatic
                                                           and supportive. No specific antidote is known for the
                                                           active substance glufosinate.

Summary (Annex IIA, point 5.10)
                                                                   Value                  Study             Safety factor
ADI                                                        0.024 mg/kg              2-generation            100
                                                           bw/day                   reproduction,
                                                                                    oral, rat
AOEL                                                       0.0021 mg/kg             developmental           300§
                                                           bw/day*                  study, oral
                                                                                    exposure rabbit
ARfD (acute reference dose)                                0.021 mg/kg              developmental           300§
                                                           bw/day                   study, oral
                                                                                    exposure rabbit
          *dermal exposure considered the most relevant route of operator exposure. Oral absorption = 10%
          §
            Extrafactor of 3, due to severity of toxicity (reproduction Category 2)


Dermal absorption (Annex IIIA, point 7.3)
Preparation Basta / Liberty SL18: undiluted                7.3 % (10-h exposure in vivo rat)
                as spraying dilution                       8.8 % (10-h exposure in vivo rat)
                                                           Penetration factor human vs rat skin:             1
Preparation Basta SL14: undiluted                          16 % (10-h exposure in vivo rat)
               as spraying dilution                        14 % (10-h exposure in vivo rat)
                                                           Penetration factor human vs rat skin:             1

Acceptable exposure scenarios
Operator                                                   Apple orchards
                                                           Acceptable uses were identified for apple orchards for
                                                           tractor mounted hand held pressure sprayers with hose
                                                           and spray lance with shields and apple orchards for
                                                           tractor mounted with small booms and single nozzle and
                                                           protective wings with the formulations Basta SL 18 and
                                                           Basta SL14.

                                                           Potatoes
                                                           No safe use was identified for potatoes with either Basta
                                                           SL 18 or Basta SL 14.

                                                           LL maize
                                                           There is no identified safe use of the GA product Liberty
                                                           SL18 for the scenario with tractor mounted boom
                                                           sprayers in LL maize.

Workers                                                    Apple orchards
                                                           Potatoes and LL maize
                                                           Not relevant since re-entry is considered not necessary
                                                           shortly after spraying.
Bystanders                                                 Apple orchards
                                                           Acceptable exposure for the bystanders in apple orchards.

                                                           Potatoes and LL maize
                                                            Not possible to assess based on the operator exposure
                                                           since the operator exposure exceeds the systemic AOEL.
RMS: SE                                              - 12 -                                    December 2002
                                                                                               December 2003
                                           GLUFOSINATE-AMMONIUM
                                              Volume 1 - Level 4
2.4      Residues
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)
plant groups covered:                                      Non-selective use: Pome fruit (apple)
                                                           Selective use: Cereal grain (maize)
rotational crops:                                          -
plant residue definition for monitoring:                   Sum of glufosinate, 3-methyl-phosphinico-propionic
                                                           acid, and N-acetyl-glufosinate expressed as
                                                           glufosinate free acid equivalents.
                                                           The same definition for (non-selective and selective
                                                           use).
plant residue definition for risk assessment:              As above
conversion factor (monitoring to risk                      1
assessment):


Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
animals covered:                                           Lactating goat and laying hens
metabolism in rat and ruminant the same?                   Yes
animal residue definition for risk assessment:             Sum of glufosinate, 3-methyl-phosphinico-propionic
                                                           acid, and N-acetyl-glufosinate expressed as
                                                           glufosinate free acid equivalents
animal residue definition for monitoring?                  As above
conversion factor (monitoring to risk                      1
assessment):


fat soluble residue                                        No


Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
                                                    Results indicate that glufosinate and its
                                                    metabolites are not likely to accumulate and reach
                                                    significant levels of residue in succeeding crops.
                                                    In case of crop failure which requires destruction
                                                    of the crop before harvest, major residues that
                                                    could be available to succeeding crops include
                                                    parent glufosinate, MPP (and MPA which fell
                                                    below 10 % of TRR)



Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)
                                                      As shown in the results of other sections,
                                                      glufosinate is rapidly metabolized in soil and
                                                      plants. The residues found in the soil into which
                                                      rotational crops are planted is low and declines
                                                      rapidly with time. The uptake of glufosinate and
                                                      metabolites by plants is likewise low, and as
                                                      indicated by the confined rotational crop study
                                                      residue levels below 0.1 ppm are reached in less
                                                      than 120 days. A majority of these residues are
                                                      non-extractable indicating that radiocarbon has
                                                      been incorporated into natural plant constituents.
RMS: SE                                                    - 13 -                                         December 2002
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                                             GLUFOSINATE-AMMONIUM
                                                Volume 1 - Level 4

                                                             Therefore, the potential for glufosinate and its
                                                             metabolites to accumulate in the soil or in crops is
                                                             low. Residues in potato are stable for one year
                                                             under frozen conditions. Residues in apple and
                                                             transgenic maize are stable up to 24 months under
                                                             frozen conditions. For poultry and cattle residues
                                                             are stable for a period up to 15 months.




Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)
Intakes by livestock  0.1 mg/kg diet/day:                         Ruminant:                Poultry:             Pig:
(for 1 x dose)                                                      yes/no                   yes/no             yes/no
Muscle                                                                no                       no                  -
Liver                                                                 no*                      no                    -
Kidney                                                                no*                     no*                    -
Fat                                                                    no                      no                    -
Milk                                                                   no                      na                    na
Eggs                                                                   na                      no                    na
*: but residues of MPP after dosing of this metabolite: liver 1.1 mg/kg, kidney 0.38 (r.) and 0.68 (p.) mg/kg
na: not applicable




These tables below exclude the outcome of 7 days feeding with control diet.
Intakes by              Ruminant:                   Poultry:                              Pig:
livestock               Dairy cows:                 Normal dose feed (1 X)                No feeding studies with
mg/kg diet:             Normal dose feed            of GA: 3,5 mg/kg dry weight           pigs were deemed to be
                        (1 X) of GA: 3,0            of MPP: 1,0 mg/kg dry weight          necessary as the pattern
                        mg/kg dry weight *          Recieved also 3 X and 10 X            for excretion and
                        and of MPP 1,0 mg/kg        dose. Dosage period 28 days           metabolism is
                        dry weight *                                                      comparable between rat
                        Recieved also 3 X and                                             and ruminant.
                        10 X dose. Dosage
                        period 28 days
                        Residues, mg/kg**           Residues, mg/kg**
Muscle (raw):           < 0,05 for both GA          < 0,05 for both GA and MPP
                        and MPP for all dose        for all dose levels
                        levels
Muscle (cooked):        < 0,10 for both GA          < 0,10 for both GA and MPP
                        and MPP for all dose        for all dose levels
                        levels
Diaphragm               < 0,10 for both GA          No data
muscle:                 and MPP for all dose
                        levels
Stock:                  < 0,05 for both GA          < 0,05 for both GA and MPP
                        and MPP for all dose        for all dose levels
                        levels
Blood:                  < 0,06 for GA for all       No data
                        dose levels
                        < 0,05 for MPP for all
                        dose levels
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                                          GLUFOSINATE-AMMONIUM
                                             Volume 1 - Level 4
Liver:                 < 0,10 for GA one          < 0,10 for both GA and MPP
                       sample contained 0.13      for all dose levels
                       mg/kg on the 1 X dose
                       MPP: (1 X): 1,1
                       mg/kg
                       (3 X): 4,0 mg/kg
                       (10 X): 8,9 mg/kg
Kidney:                GA: < 0,10 for all         GA: < 0,05 (1 X dose); 0,07 (3
                       dose levels except 10      X dose); 0,23 (10 X dose)
                       X rate where one           MPP: 0,69 (1 X dose); 2,0 (3 X
                       sample contained 0.13      dose); 7,8 (10 X dose)
                       mg/kg
                       MPP: (1 X): 0,38
                       mg/kg
                       (3 X): 1,4 mg/kg
                       (10 X): 5,3 mg/kg
Fat:                   GA: < 0,05 mg/kg for       < 0,05 for both GA and MPP
                       all dose rates except      for all dose levels
                       for 1 X rate where one
                       sample contained 0,06
                       mg/kg
                       MPP: (1 X): < 0,05
                       mg/kg
                       (3 X): 0,06 mg/kg
                       (10 X): 0,10 mg/kg
Milk:                  < 0,02 for both GA         No data
                       and MPP for all dose
                       levels;
                       for one cow, residues
                       at 0.03 mg/kg were
                       determined on days 0
                       and 1 for GA on 3 X
                       dose
Eggs:                  No data                    GA: < 0,05 for all dose levels
                                                  except the 10 X dose which
                                                  gave 0,07
                                                  MPP: < 0,05 for all dose levels
** Residues are expressed as glufosinate free acid AE F035956 equivalents
* Total ration was calculated as 15 kg dry weight per animal per day




Intakes by livestock     Ruminant:                   Poultry (laying hens):              Pig:
mg/kg diet:              Dairy cows:                 Normal dose feed expressed as       No feeding studies with
                         Normal dose feed            glufosinate free acid equivalents   pigs were deemed to be
                         (1 X) of GA and NAG:        (1 X): 0,41 mg/kg dry weight        necessary as the pattern for
                         9,11 mg/kg dry weight       Recieved also 3 X and 10 X dose.    excretion and metabolism
                         **                          Dosage period 28 days with GA       is comparable between rat
                         Received also 3 X and       and NAG                             and ruminant.
                         10 X dose. Dosage
                         period 28 days
                         Residues, mg/kg**           Residues, mg/kg
Muscle:                  < 0,05 for both             < 0,05 for both (GA+NAG) and
                         (GA+NAG) and MPP            MPP for all dose levels
                         for all dose levels
RMS: SE                                                  - 15 -                                     December 2002
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                                           GLUFOSINATE-AMMONIUM
                                              Volume 1 - Level 4
Skin:                      No data                    < 0,05 for both (GA+NAG) and
                                                      MPP for all dose levels
Stock:                    No data
Liver:                    (GA+NAG): < 0,10 for        < 0,10 for both (GA+NAG) and
                          all doses                   MPP for all dose levels
                          MPP: 1 X dose and 3 X
                          dose: < 0,10
                          10 X dose: 0.282, 0.292
                          and 0.246
Kidney:                   (GA+NAG): 1 X dose          No data ?
                          and 3 X dose: < 0,10
                          10 X dose: 0.107, 0.138
                          and 0.150
                          MPP: 1 X dose and 3 X
                          dose: < 0,10
                          10 X dose: <0.10, <0.10
                          and 0.130
Fat:                      < 0,05 for both             < 0,05 for both (GA+NAG) and
                          (GA+NAG) and MPP            MPP for all dose levels
                          for all dose levels
Milk:                     (GA+NAG): 1 X dose:         No data
                          < 0,02
                          2 X dose: <0.02 to
                               0.028
                          10 X dose: <0.02 to
                          0.229a
                          MPP: < 0,02 for 1 X
                          dose and 3 X dose. For
                          10 X dose: <0.02 except
                          0.026a and 0.030a
Eggs:                     No data                     < 0,05 for both (GA+NAG) and
                                                      MPP for all dose levels
a)     These figures are from one animal which had low feed intake and low milk production between days 16 and 18;
       otherwise, no residues of MPP were found and the parent compound / AE F09730 residues were at a relatively steady
       level from day 3 onwards (between 0.024 and 0.072 mg/kg).




Summary of critical residues data (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Crop                Northern or             Trials results          Recommendation/       MRL        STMR (b)
                    Southern                relevant to the         comments
                    Region                  critical GAP (a)
                                            GA+NAG+MPP
Apple               Northern                9x<0.05 mg/kg           Formulations:         0.1        0
                                                                    SL14, SL18, SL19      mg/kg
                                                                    (150-200g as/L
Apple               Southern                8x<0.05 mg/kg           Formulations          0.1        0
                                                                    SL14, SL 18, SL19     mg/kg
                                                                    (150-200g as/L
Potato              Northern                3x0.1, 3x0.12-0.13,     Formulations          0.5        0.16
                                            4x0.15-0.16, 1x0.2,     SL14, SL18 (150-      mg/kg
                                            3x0.23-0.26 mg/kg,      200g as/L), 12 SC
RMS: SE                                                      - 16 -                                         December 2002
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                                              GLUFOSINATE-AMMONIUM
                                                 Volume 1 - Level 4

                                              3x0.37-0.49                13 (90g as/L)
Potato             Southern                   2x 0.16-0.26,              Formulations            0.5          0.16
                                              2x0.37-0.39,               SL14, (150as/L),        mg/kg
                                                                         12 SC 13 (90g
                                                                         as/L)
Maize grain        Northern                   17x<0.05 mg/kg             Formulation SL          0.1          0
                                                                         18 200 g as/L)          mg/kg
Maize grain        Southern                   18x<0.05, 1x0.05,          Formulation             0.1          0.05
                                              1x0.16 (outlier)           SL18, SL11              mg/kg
                                              mg/kg                      (120-200 g as/L
(a) Number of trials in which particular residue levels were reported e.g. 3 x <0.01, 1 x 0.01, 6 x 0.02, 1 x 0.04, 1 x 0.08, 2 x
0.1, 2 x 0.15, 1 x 0.17
Supervised trials median residue i.e. the median residue level estimated on the basis of supervised trials relating to the critical
GAP


Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)
Based on FAO/WHO EURdiet and the German model 4-6 year old girl and representative crops:
ADI                                                           0.024 mg/kg bw day (temporary)
TMDI (%ADI)                                                    (EU diet) 13 %
                                                               (German model) 12 %
EMDI (%ADI)                                                    Not relevant
factors included in EMDI:                                     Not relevant


Acute reference dose:                                         0.021mg/kg bw day for adults
                                                              0.063 mg/kg bw for toddlers
NESTI (%ARfD)                                                 Adults : apples 5 %, potatoes all 55%, maize 10%,
                                                              potato crisps 5%
                                                              Toddlers: apples 9%, potatoes all 81%. maize 1%
                                                              potato crisps 3%




Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)
Crop/processed crop:                                Transfer factor:                                          % transference*:
Potatoes (representative crop)                      None
Apples (representative crop)                        Residues in apples from trees treated
                                                    with Basta are below the limit of
                                                    quantification and thus below the
                                                    trigger value of 0.1 mg/kg. Therefore
                                                    no processing studies are required for
                                                    apples.
Maize (glufosinate tolerant) (representative crop)  In the dry milling process a 2-fold
                                                    increase of NAG was observed in the
                                                    hulls but, when the crop is treated
                                                    according to the proposed GAP, the
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                                                             level should remain below the limit of
                                                             quantification. A 12-fold concentration
                                                             from the grain to the aspirated grain
                                                             fraction was observed.
* Calculated on the basis of distribution in the different portions, parts or products as determined through balance studies



Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)

    Crop group

    Apple                                                       0.1*
    Potato                                                      0.5
    Maize grain                                                 0.1*
    Foodstuff of Animal Origin
    Milk                                                        0.1
    Eggs of poultry                                             0.1
    Meat of poultry                                             0.1*
    Meat of ruminant                                            0.1*
    Fat of poultry                                              0.1*
    Fat of ruminant                                             0.1
    Liver of poultry                                            0.3*
    Liver of ruminant                                           2.0
    Kidney of poultry                                           0.3
    Kidney of ruminant                                          1.0
  * Limit of quantification
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2.5       Fate and Behaviour in the Environment
Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)
 Mineralization after 100 days                           20 – 62% after 120 days (n=7)

 Non-extractable residues after 100 days                 11 - 38% at 120 days (n=7)

 Relevant metabolites - name and/or code, % of           3-methylphosphinico propionic acid (MPP)
 applied (range and maximum)                             (at 20°C, max 47% after 7 days)
                                                         2-methylphosphinico acetic acid (MPA)
                                                         (at 20°C, max 26% after 14 days)

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)
 Anaerobic degradation                                   No reliable data available

 Soil photolysis                                         Essentially no degradation over equivalent of 32 days
                                                         outdoor conditions (sterile soil conditions)

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)
 Method of calculation                                   First order kinetics
 Laboratory studies                                      DT50lab (20 C, aerobic):
 (range or median, with n value, with r2 value)          GA (AE F039866):
                                                         n=10, range 5 - 10 days, mean 6.9 days, median 6.5 days,
                                                         r2>0.7

                                                         MPP (AE F061517):
                                                         Studies with MPP as parent:
                                                         n=6, range 6.8 - 14 days, mean 10 days, median 8.5,
                                                         r2>0.7
                                                         Studies with GA as parent:
                                                         n=5, range 13 – 22 days, mean 18 days, median 20,
                                                         r2>0.7

                                                         MPA (AE F064619):
                                                         Studies with MPA as parent:
                                                         n=4, range 8.1 - 23 days, mean 13 days, median 9 days,
                                                         r2>0.90
                                                         Studies with MPP as parent:
                                                         n=2, 28 and 50 days, mean 39, median 39, r 2>0.90
                                                         Studies with GA as parent:
                                                         n=2, 18 and 21 days, mean 20, median 20, r 2>0.90

                                                         NAG (AE F099730):
                                                         Study with NAG as parent:
                                                         n=2., 0.5 and 1.0 days, mean 0.75, median 0.75, r 2>0.7

                                                         DT90lab (20C, aerobic)*: GA only, n=10, range 18 - 32
                                                         days, mean 25, median 24, r2>0.7
                                                         DT50lab (10C, aerobic): GA only, n=1, 18 days, r2>0.99
                                                         DT50lab (20C, anaerobic): no reliable data available
 Degradation in the saturated zone                       Degradation in the saturated zone was not investigated,
                                                         not required.

 Field studies (state location, range or median with n   DT50f:field dissipation studies not required
 value)
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                                                        DT90f: field dissipation studies not required
 Soil accumulation and plateau concentration            Soil accumulation study not required




 Soil adsorption/desorption (Annex IIA, point 7.1.2)
 Kf /Koc                                                There was no correlation between the sorption
                                                        coefficients (Kf-values) of GA or metabolites MPP and
 Kd
                                                        MPA and the organic carbon content of the test soils. As
 pH dependence (yes / no) (if yes type of               the OC-content of the soils has little influence on the
 dependence)                                            sorption behaviour of GA, it is not pertinent to calculate
                                                        a Koc-value since this concept assumes that the OC-
                                                        content is the dominant sorption influencing factor.

                                                        The Kf values of GA from the upper soil layers generally
                                                        ranged from 0.2 – 3.4 (n=16), with one outlier of Kf=10.

                                                        Experiments with pure clay minerals indicated that the
                                                        sorption of GA was correlated to the clay content of the
                                                        soil. For the metabolites MPP and MPA, partly due to
                                                        fewer data, the correlation was more uncertain.

                                                        For GA, based on n = 56 sorption values (top soil and
                                                        deeper soil layers), the majority of the values fit the
                                                        regression: Kf(GA) = 0.136 x %clay with the correlation
                                                        r2 = 0.67.

                                                        For MPP, correlation with the clay content of the soils
                                                        was found resulting in the regression Kf = 0.048 x %clay
                                                        + 0.2 with a correlation coefficient of r2 = 0.51. (n=7)

                                                        For MPA, the best correlation of the Kf-value was found
                                                        with the pH-value and the clay fraction yielding the
                                                        equation: Kf = 0.165 x %clay – 1.57 pH + 9.8 with
                                                        r2 = 0.93. (n=5).
                                                         .... .



Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)
 Column leaching                                        No data required. However, available data indicate
                                                        significant potential for leaching of GA.
 Aged residues leaching                                 No data required. However, available data indicate
                                                        significant potential for leaching of GA and metabolites
                                                        in soil.
 Lysimeter/ field leaching studies
                                                        Two lysimeters with sandy loam and silt loam soils in
                                                        Germany. Lysimeter surface area 0.8 m2 and 1.2-1.3 m
                                                        depth. Two applications the first two years; 1.5+1.0 kg
                                                        as/ha to vines in May 1987. Rainfall 660-750 mm/year.
                                                        Terminated after 3 years. LOD = 0.05 µg/L
                                                        Results: No detectable amount active substance or
                                                        metabolite in leachate in any of the lysimeters.

                                                        Field leaching study with two spring applications of 0.8
                                                        kg as/ha to glufosinate-tolerant maize in Germany.
                                                        Annual precipitaion (rainfall+irrigation) was >800 mm.
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                                                          LOQ 0.05 g/L.

                                                          Results: No residues of glufosinate and its metabolites
                                                          were found in the soil profile after half a year, generally
                                                          no leaching of the test substance below a level of 30 cm
                                                          was detected.

                                                          Field leaching study with autumn and spring applications
                                                          of 0.8 kg as/ha to glufosinate-tolerant oilseed rape in
                                                          UK. Annual precipitaion (rainfall+irrigation) was >800
                                                          mm. LOQ 0.05 g/L.

                                                          Results: GA and MPP recovered in soil water at 150 cm
                                                          depth at concentrations >0.1 ug/L. MPA less mobile than
                                                          GA, MPP more mobile than GA.

                                                          Field leaching study with autumn and spring applications
                                                          of 0.8 kg as/ha to glufosinate-tolerant oilseed rape in
                                                          Germany.......




PEC (soil) (Annex IIIA, point 9.1.3)
 Method of calculation                                    First order kinetics based on a DT 50 of 10 days for GA,
                                                          22 days for MPP, 21 days for MPA. Correction for
                                                          molecular weight.
 Application rate                                         1.5 + 1.0 kg a.s./ha, 30 day application interval, 0%
                                                          interception

PEC(s)               Days after maximum       PEC GA                     PEC MPP                PEC MPA
                                              (mg/kg dw)                 (mg/kg dw)             (mg/kg dw)
                                              Actual       TWA           Actual       TWA       Actual       TWA
Initial              0                        2.0          -             0.72         -         0.36         -
                     1                        1.9          1.9           0.70         0.71      0.35         0.36
                     2                        1.7          1.9           0.68         0.70      0.34         0.35
                     4                        1.5          1.7           0.64         0.68      0.32         0.34
                     7                        1.2          1.6           0.58         0.65      0.29         0.32
                     14                       0.76         1.3           0.46         0.58      0.23         0.29
                     28                       0.29         0.88          0.30         0.48      0.14         0.24
                     50                       0.06         0.56          0.15         0.36      0.07         0.18
                     100                      0.002        0.29          0.03         0.22      0.01         0.11




Route and rate of degradation in water (Annex IIA, point 7.2.1)
 Hydrolytic stability of active substance and relevant    pH 5: GA stable at 25 ºC (DT50 > 300 days)
 metabolites (DT50) (state pH and temperature)            pH 7: GA stable at 25 ºC (DT50 > 300 days)
                                                          pH 9: GA stable at 25 ºC (DT50 > 300 days)

 Photolytic degradation of active substance and           GA is stable to aqueous photolysis at pH 5 to 9
 relevant metabolites
 Readily biodegradable (yes/no)                           No data available
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 Degradation in      - DT50 water                        GA: range 1.4 – 13 days at 20º C (n=3)
 water/sediment                                          MPP: ca 150 days at 20º C (n=2)
                                                         No data on other metabolites

                    - DT90 water                         GA: range 5 - 44 days at 20º C (n=3)
                                                         MPP: >>150 days at 20º C (n=2)
                                                         No data on other metabolites

                    -DT50 whole system                   GA: range 2 – 11 days at 20º C (n=3)
                                                         MPP: >200 days at 20º C (n=2)
                                                         No data on other metabolites
                    - DT90 whole system
                                                         GA: range 5 – 34 days at 20º C (n=3)
                                                         MPP: >200 days at 20º C (n=2)
                                                         No data on other metabolites

 Mineralization                                          range 7 – 17% after 130 days (n=3)
 Non-extractable residues                                Generally less than 10% during the study period
 Distribution in water / sediment systems (active        Predominantly in water phase; maximum 13% of applied
 substance)                                              radioactivity found as GA in sediment during the first
                                                         week of incubation.
 Distribution in water / sediment systems                Predominantly in water phase; no metabolite exceeds
 (metabolites)                                           10% of applied in sediment.

PEC (surface water) for active ingredient and metabolite MPP (Annex IIIA, point 9.2.3)
 Method of calculation                                   First order kinetics based on a DT 50 of 13 days for GA,
                                                         150 days for MPP. For other metabolites, initial PEC
                                                         only, based on maximum amounts found in
                                                         water/sediment systems (MPP 80%, MPA 17%, MPF
                                                         22%, P-X 12%, NAG 12% of applied, correction for
                                                         molecular weight).
 Application rate                                        1.5 + 1.0 kg a.s./ha, 30 days application interval, 0%
                                                         crop interception.
 Main routes of entry                                    Spray drift + runoff/drainage according to draft (June
                                                         2002) FOCUS surface water scenarios Step 2 for GA.
                                                         For metabolites, Step 1 only.


 PEC(sw)                  Parent compound     Parent compound          Metabolite MPP           Metabolite MPP
                               Actual           Time weighted               Actual              Time weighted
                                                   average                                         average
                               (mg/L)              (mg/L)                   (mg/L)                 (mg/L)
 Initial*                       0.081                 -                      0.21                     -
  Short term
          2 days               0.073                   0.077                 0.16                     0.16
          4 days               0.065                   0.073                 0.16                     0.16
          7 days               0.056                  0.0.067                0.16                     0.16

 Long term
        14 days                0.038                  0.057                  0.15                     0.16
        21 days                0.026                  0.049                  0.15                     0.15
        28 days                0.018                  0.042                  0.14                     0.15

*maximum concentration after the first application.
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 PEC(sw)                 Metabolite MPA          Metabolite MPF         Metabolite P-X          Metabolite NAG
                                                                             (mg/L)                  (mg/L)
                             (mg/L)                  (mg/L)
 Maximum                      0.031                   0.036                  0.026                    0.036

PEC (surface water) for the SL14 and SL18 formulations (expressed as active ingredient) (Annex IIIA,
point 9.2.3)
 Method of calculation                                   First order kinetics based on a DT 50 of 13 days for the
                                                         formulations.
 Application rate                                        Maximum single application, 1.5 kg a.s./ha, 0% crop
                                                         interception.
 Main routes of entry                                    Spray drift only, since formulants other than GA are
                                                         readily biodegradable. 2.8% of the hectare dose.


 PEC(sw)                   Formulation             Formulation            Formulation            Formulation
                             Actual               Time weighted             Actual              Time weighted
                                                     average                                       average
                            (mg as/L)               (mg as/L)              (mg as/L)              (mg as/L)
 Initial                      0.015                     -                      -                      -
  Short term                                                                   -                      -
         2 days               0.014                   0.014
         4 days               0.012                   0.014
         7 days               0.011                   0.013

 Long term                                                                      -                      -
        14 days               0.007                   0.011
        21 days               0.005                   0.009
        28 days               0.003                   0.008


PEC (sediment)
 Method of calculation                                   Initial values only, based on maximum amount 13%
                                                         partitioned to sediment in one water/sediment system.
                                                         Only the parent compound >10% of applied found in the
                                                         sediment.
                                                         Assumptions: 0.3 m deep water body at a distance of 1 m
                                                         from the target crop, and an assumption of 13% in the
                                                         sediment is used. Maximum concentration in the 0 - 5
                                                         cm sediment layer (bulk density of sediment 0.8 g/cm3).
 Application rate                                        1.5 + 1.0 kg a.s./ha, 30 day application interval, 0%
                                                         interception
 Main routes of entry                                    Spray drift + runoff/drainage according to draft (version
                                                         June 2002) FOCUS surface water scenarios Step 2.

 PEC(sed)                Parent compound         Parent compound          Metabolites              Metabolites
                             Actual               Time weighted             Actual               Time weighted
                                                     average                                        average
                        (mg/kg ww)/(mg/L)          (mg/kg ww)             (mg/kg ww)              (mg/kg ww)
 Maximum                    0.08/0.06                   -                      -                       -

PEC (ground water) (Annex IIIA, point 9.2.1)
 Method of calculation and type of study (e.g.           Modelling with PELMO version 1.1.1; FOCUS scenarios
 modelling, monitoring, lysimeter )                      and laboratory data
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                                                       Lysimeter study (spring + early autumn application)
                                                       Field leaching study, oilseed rape crop scenario

 Application rate                                      (2 x 0.8 kg/ha) to (1.5 + 1.0 kg/ha)

 PEC(gw)
 Maximum concentration                                 GA and metabolites < 0.1 µg/L in FOCUS simulations,
                                                       Field leaching study in UK oilseed rape, autumn + spring
                                                       application (2 x 0.8 kg/ha):
                                                       GA max 5.5 g/L at 75 cm depth
                                                       MPP max 56 µg/L at 75 cm depth, 3.8 g/L at 150 cm
                                                       MPA max 0.76 g/L at 75 cm depth
                                                       However, study less reliable; new study available early
                                                       2003.
 Average annual concentration                          80%ile of the annual averages < 0.1 µg/L in FOCUS
                                                       simulations for parent and metabolites

Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)
 Direct photolysis in air                              Not required; vapour pressure of product low

 Quantum yield of direct phototransformation           Zero.

 Photochemical oxidative degradation in air
                                                       Standard Atkinson calculation: DT 50 = 0.5 days.
                                                       (European scenario with 106 radicals/m³ and a time
                                                       frame of 24 hours/day)
 Volatilization                                        from plant surfaces: not expected due to low v.p.
                                                       from soil: not expected due to low v.p.

PEC (air)
 Method of calculation                                 Not relevant.


 PEC(a)
 Maximum concentration                                 Not calculated. Low vapour pressure.


Definition of the Residue (Annex IIA, point 7.3)
 Relevant to the environment                           Soil:
                                                       Glufosinate-ammonium (AE F039866) expressed as free
                                                       acid
                                                       MPP (AE F061517)
                                                       MPA (AE F064619)
                                                       Surface water:
                                                       Glufosinate-ammonium (AE F039866) expressed as free
                                                       acid
                                                       MPP (AE F061517)
                                                       MPA (AE F064619)
                                                       MPF (AE F130947)
                                                       Groundwater:
                                                       MPP (AE F061517)
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Monitoring data, if available (Annex IIA, point 7.4)
 Soil (indicate location and type of study)            No data submitted.

 Surface water                                         No data submitted.
 (indicate location and type of study)
 Ground water                                          National regional monitoring in France, Burgundy
 (indicate location and type of study)                 region. Ongoing program. No residues of GA found in
                                                       ground water. Limited value.
 Air (indicate location and type of study)             Not data submitted.
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                                           GLUFOSINATE-AMMONIUM
                                              Volume 1 - Level 4
2.6      Effects on Non-target Species
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)
 Acute toxicity to mammals                                  Moderate, LD 50 mouse 437 mg/kg bw (most sensitive
                                                            relevant species)
 Acute toxicity to birds                                    LD50 >2000 mg/kg bw on 4 species
 Dietary toxicity to birds                                  LC50 1100 mg/kg bw day for bobwhite quail
 Reproductive toxicity to mammals                           NOAEL 6.3 mg as/kg bw day for rabbit (developmental
                                                            study)
 Reproductive toxicity to birds                             NOAEL 40 mg as/kg bw day for bobwhite quail

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)¤¤Lägg till fler arter!
 Application         Crop               Category                            Time-scale         TER            Annex VI
 rate                                   (e.g. insectivorous bird)                                             Trigger
 (kg as/ha)
 1.5                 apple orchard      small insectivorous bird            acute              >25            10
 0.8                 GMO maize          large herbivorous bird              acute              >31            10
 0.8                 GMO maize          small insectivorous bird            acute              >45            10
 0.6                 potatoes           medium herbivorous bird             acute              >50            10
 0.6                 potatoes           small insectivorous bird            acute              >63            10
 1.5                 apple orchard      small insectivorous bird            short term         24             10
 0.8                 GMO maize          large herbivorous bird              short term         27             10
 0.8                 GMO maize          small insectivorous bird            short term         46             10
 0.6                 potatoes           medium herbivorous bird             short term         60             10
 0.6                 potatoes           small insectivorous bird            short term         61             10
 1.5                 apple orchard      medium omnivorous bird              long term          7.0*           5
 0.8                 GMO maize          large herbivorous bird              long term          2.6*           5
 0.8                 GMO maize          small insectivorous bird            long term          1.7            5
 0.6                 potatoes           medium herbivorous bird             long term          n.r.           -
 0.6                 potatoes           small insectivorous bird            long term          n.r.           -
 1.5                 apple orchard      small herbivorous mammal            acute              1.4            10
 0.8                 GMO maize          small herbivorous mammal            acute              2.0            10
 0.6                 potatoes           medium herbivorous mammal           acute              28             10
 0.6                 potatoes           small insectivorous mammal          acute              78             10
 1.5                 apple orchard      small herbivorous mammal            long term          0.06           5
 0.8                 GMO maize          small herbivorous mammal            long term          0.07           5
 0.6                 potatoes           medium herbivorous mammal           long term          1.4**          5
 0.6                 potatoes           small insectivorous mammal          long term          3.3**          5
*the figures are refined to some extent
**the scenarios are considered acceptable; Due to the rapid wilting of non-GMO field crops (2 – 7 days depending on
weather conditions), exposure will be limited.
n.r. = not relevant

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA,
point 10.2)
 Group                        Test substance        Time-scale        Endpoint                    Toxicity
                                                                                                  (mg/L)
 Laboratory tests
 Oncorhynchus mykiss          glufosinate-          96 hours          LC50                        710
 (rainbow trout)              ammonium
 Oncorhynchus mykiss          glufosinate-          21 days           NOEC                        100
 (rainbow trout)              ammonium
 Daphnia magna                glufosinate-          48 hours          EC50                        668
 (water flea)                 ammonium
 Daphnia magna (water         glufosinate-          21 days           NOEC                        18
 flea)                        ammonium
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                                   GLUFOSINATE-AMMONIUM
                                      Volume 1 - Level 4

Group                      Test substance   Time-scale        Endpoint       Toxicity
                                                                             (mg/L)
Mysidopsis bahia (mysid    glufosinate-     48 hours          EC50           7.5
shrimp)                    ammonium                           NOEC           0.75*
Pseudokirchneriella        glufosinate-     72 hours          ErC50          >80
subcapitata (green alga)   ammonium                           NOEC           2.5
Lemna gibba (higher        glufosinate-     14 days           EbC50          1.5
aquatic plant)             ammonium                           NOEC           0.8
Oncorhynchus mykiss        MPP              96 hours          LC50           >100
(rainbow trout)
Oncorhynchus mykiss        MPP              28 days           NOEC           21
(rainbow trout)
Daphnia magna (water       MPP              48 hours          EC50           >100
flea)
Daphnia magna (water       MPP              28 days           NOEC           <4.4
flea)
Scenedesmus subspicatus    MPP              72 hours          ErC50          >1000
(green alga)                                                  NOEC           1000
Lemna gibba (higher        MPP              7 days            ErC50          >78
aquatic plant)                                                NOEC           78
Oncorhynchus mykiss        MPA              96 hours          LC50           >76
(rainbow trout)
Daphnia magna (water       MPA              48 hours          EC50           911
flea)
Scenedesmus subspicatus    MPA              72 hours          ErC50          >180
(green alga)                                                  NOEC           18
Lemna gibba (higher        MPA              7 days            ErC50          >76
aquatic plant)                                                NOEC           76
Oncorhynchus mykiss        NAG              96 hours          LC50           84
(rainbow trout)
Daphnia magna (water       NAG              48 hours          EC50           >298
flea)
Scenedesmus subspicatus    NAG              72 hours          ErC50          >277
(green alga)                                                  NOEC           277
Lemna gibba (higher        NAG              7 days            ErC50          No data
aquatic plant)                                                NOEC
Oncorhynchus mykiss        MPF              96 hours          LC50           >78
(rainbow trout)
Daphnia magna (water       MPF              48 hours          EC50           >74
flea)
Pseudokirchneriella        MPF              96 hours          ErC50          >74
subcapitata (green alga)                                      NOEC           74
Lemna gibba (higher        MPF              7 days            ErC50          No data
aquatic plant)                                                NOEC
Oncorhynchus mykiss        SL18 / SL14      96 hours          LC50           14 /13
(rainbow trout)
Oncorhynchus mykiss        SL18 / SL14      21 days/28 days   NOEC           0.5 / 0.8
(rainbow trout)
Daphnia magna (water       SL18 / SL14      48 hours          EC50           15 / 18
flea)
Daphnia magna (water       SL18 / SL14      21 days           NOEC           3.2 / 3.2
flea)
Scenedesmus subspicata     SL18             72 hours          ErC50          36
(green alga)                                                  NOEC           32
Pseudokirchneriella        SL14             96 hours          ErC50          64
subcapitata (green alga)                                      NOEC           32
Lemna gibba (higher        SL18             7 days            EbC50          10
aquatic plant)                                                NOEC           3.2
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 Group                          Test substance         Time-scale            Endpoint                  Toxicity
                                                                                                       (mg/L)
 Lemna gibba (higher           SL14                   7 days              EbC50                        10
 aquatic plant)                                                           NOEC                         3.2
 Microcosm or mesocosm tests
 As the acute and long-term toxicity exposure values are above 100 and 10, microcosm or mesocosm studies are
 not necessary. Data from literature with outdoor testing confirm this assumption.
*estimated value, assessment factor 10 for long term effects



Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Calculations based on predicted initial aquatic concentrations after the worst case application rate of 1.5 + 1.0 kg
as/ha, 30 days interval between treatments. TER values based on initial concentrations. Aquatic half-life of GA
13 days, MPP 150 days.
     Application            Crop         Organism (based on     Time-scale      Distance      TER         Annex VI
         rate                               preparation)                          (m)                      Trigger
      (kg as/ha)
 1.5 + 1.0            apple orchard           Fish, GA          short term       1**          2150           100
 30 days interval                             Fish, GA          long term        1**          385             10
                                             Fish, MPP          short term       1**          625            100
                                             Fish, MPP          long term        1**          131             10
                                             Fish, MPA          short term       1**          2452           100
                                             Fish, NAG          short term       1**          2333           100
                                             Fish, MPF          short term       1**          2167           100
                                             Fish, SL18         short term        1*          173            100
                                             Fish, SL18         long term         1*           11             10
                                             Fish, SL14         short term        1*          127            100
                                             Fish, SL14         long term         1*           14             10
                      apple orchard         Daphnia, GA         short term       1**          2569           100
                                            Daphnia, GA         long term        1**           69             10
                                           Mysidopsis, GA       short term       1***          93            100
                                           Mysidopsis, GA       long term        1***         10.3            10
                                           Daphnia, MPP         short term       1**          625            100
                                           Daphnia, MPP         long term        1**          <28             10
                                           Daphnia, MPA         short term       1**          1967           100
                                           Daphnia, NAG         short term       1**          8278           100
                                           Daphnia, MPF         short term       1**          2056           100
                                           Daphnia, SL18        short term        1*          180            100
                                           Daphnia, SL18        long term         1*           66             10
                                           Daphnia, SL14        short term        1*          167            100
                                           Daphnia, SL14        long term         1*           47             10
                      apple orchard          Algae, GA          short term       1**          308             10
                                             Algae, GA          long term        1**           9.6             -
                                            Algae, MPP          short term       1**          6250            10
                                            Algae, MPP          long term        1**          6250             -
                                            Algae, MPA          short term       1**          5806            10
                                            Algae, MPA          long term        1**          580              -
                                            Algae, NAG          short term       1**          7694            10
                                            Algae, NAG          long term        1**          7694             -
                                            Algae, MPF          short term       1**          2056            10
                                            Algae, MPF          long term        1**          2056             -
                                            Algae, SL18         short term        1*          467             10
                                            Algae, SL14         short term        1*          593             10
                      apple orchard         Lemna, GA           short term       1***          19             10
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                                            GLUFOSINATE-AMMONIUM
                                               Volume 1 - Level 4

                                                 Lemna, GA           long term         1***          15            5
                                                 Lemna, MPP          short term         1**         488            10
                                                 Lemna, MPP          long term          1**         488            5
                                                Lemna, MPA           short term         1**         2452           10
                                                Lemna, MPA           long term          1**         2452           5
*for formulated products, spray drift only was considered as exposure route to surface water.
**based on Step 1 exposure assessment, spray drift and runoff/drainage included.
***based on Step 2 exposure assessment, spray drift and runoff/drainage included.




Bioconcentration
 Bioconcentration factor (BCF)                                 Study not triggered, since log Pow < 3 for both parent
                                                               compound and metabolites. Nevertheless a study is
                                                               available and presented. BCF <1.
 Annex VI Trigger for the bioconcentration factor              1000 for readily biodegradable substances
                                                               100 for not readily biodegradable substances
 Clearance time (CT50)                                         Rapid elimination of GA and degradation products in 24
                               (CT90)                          hours. Kinetic parameter cannot be calculated.

 Level of residues (%) in organisms after the 14 day           Total radioactive residues < 0.01 mg/kg.
 depuration phase


Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)
 Acute oral toxicity                                           > 600 µg as/bee in studies with active ingredient
                                                               46 µg as/bee in studies with SL14
                                                               >100 µg as/bee in studies with SL18
 Acute contact toxicity                                        > 346 µg as/bee in studies with the active ingredient
                                                               100 µg as/bee in studies with SL14
                                                               >100 µg as/bee in studies with SL18

Hazard quotients for honey bees (Annex IIIA, point 10.4)
   Application rate         Crop                             Route            Hazard quotient              Annex VI
     (kg as/ha)                                                                                             Trigger
 Laboratory tests
 Basta SL18/Basta SL14
 1.5                apple orchard                    Oral                    < 15/33               50
 1.5                      apple orchard              Contact                 < 15/9.7              50
 Liberty SL18
 0.8                      GMO maize                  Oral                     < 8.0                50
 0.8                GMO maize                        Contact                 < 8.0                 50
 Basta SL18/Basta SL14
 0.6                Potatoes                         Oral                    < 6/13                50
 0.6                      Potatoes                   Contact                 < 6/3.4               50

 Field or semi-field tests
 As the hazard quotients for the contact and the oral exposure QHC and QHO to the formulated products are
 less than 50, further tests are not required.

Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)
    Species            Stage             Test             Dose            Endpoint              Effect          Annex VI
                                      Substance *       (kg as/ha)                                               Trigger
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                                              Volume 1 - Level 4
    Species            Stage            Test             Dose            Endpoint                 Effect              Annex VI
                                     Substance *       (kg as/ha)                                                      Trigger
 Laboratory tests
 Aphidius        adults             SL18             0.6, 1.6, 2.5    mortality         at all rates:             30 %
 rhopalosiphi                                                                           100% mortality
 Typhlodro-      adults             SL18             0.6, 1.6, 2.5    mortality         at all rates:             30 %
 mus pyri                                                                               100% mortality
 Typhlodro-      protonymphs        SL18             five doses       reproduction      LD50:                     -
 mus pyri                                                                               0.3 g as/ha
 Pardosa spp.    adults             SL18             0.6, 1.6, 2.5    mortality,        at all rates:             30 %
                                                                      reproduction      100% mortality
 Chrysoperla      larvae            SL18             0.6, 1.6, 2.5    mortality,        at all rates:             30 %
 carnea                                                               reproduction      >97% mortality
 Chrysoperla      larvae            SL18                  0.04        mortality,        no significant effects    30 %
 carnea                                                  0.008        reproduction
 Poecilus         adults            SL18              0.6, 1.6, 2.5   condition,        at all rates:             30 %
 cupreus                                                              feeding           0% mortality
                                                                      activity
 Aleochara        adults            SL18                   0.6        parasitisation           25%                30 %
 bilineata                                                 1.6        rate                     58%
                                                           2.5                                 65%
                                                                                         red.of paras. rate
*: The same series of laboratory studies was conducted with the SL14 preparation, showing similar results.

    Species            Stage            Test             Dose            Endpoint                 Effect              Annex VI
                                      Substance        (kg as/ha)                                                      Trigger
 extended laboratory tests
 Aphidius       adults              SL18                              mortality,          corr.        parasit.   30 %
 rhopalosiphi                                                         parasitisation    mortality      rate (%)
                                                          0.04                             0              96
                                                          0.06                             0              71
                                                          0.75                             0              29
                                                         0.125                            65               4
                                                           0.8                           100               -
 Aphidius         adults            SL14                              mortality,         corr.         parasit.   30 %
 rhopalosiphi                                                         parasitisation    mortality      rate (%)
                                                          0.03                            10              51
                                                         0.045                            15              24
                                                          0.56                            75               2
                                                         0.094                            80               -
                                                           0.6                           100               -
                                                           0.9                           100               -
 Hypoaspis        protonymphs       SL18                              juvenile              % mortality           30 %
 aculeifer                                               0.007        mortality, egg                0
                                                         0.014        production                  -7.8
                                                          0.04                                     9.8
                                                          0.07                                    -5.9
                                                           0.7                                    -5.9
                                                           1.4                                     29
 Hypoaspis        protonymphs       SL14                              juvenile              % mortality           30 %
 aculeifer                                               0.005        mortality, egg               38
                                                          0.01        production                   38
                                                          0.03                                      5
                                                          0.05                                     31
                                                           0.5                                     18
                                                           1.0                                      9
 semi-field tests
 Typhlodro-       adults            SL18                  0.04        mortality              at all rates:        30 %
 mus pyri                                                0.075                             100% mortality
                                                           0.8
 Typhlodro-       adults            SL14                  0.03        mortality              at all rates:        30 %
 mus pyri                                                0.056                             100% mortality
                                                           0.6
 Pardosa spp      adults            SL18                              mortality              % mortality          30 %
                                                          0.04                                  14
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                                            GLUFOSINATE-AMMONIUM
                                               Volume 1 - Level 4
    Species            Stage            Test               Dose           Endpoint               Effect            Annex VI
                                      Substance         (kg as/ha)                                                  Trigger
 *:interval 10                                         0.04 + 0.04*                              10
 days                                                     0.075                                  21
                                                       0.075 + 0.05*                             21
                                                            0.8                                  76
                                                        0.8 + 0.8*                               91
                                                            1.5                                  100
                                                         1.5 + 1                                 86
 Pardosa spp      adults            SL14                               mortality              % mortality          30 %
                                                           0.03                                  17
 *:interval 10                                         0.02 + 0.02*                              34
 days                                                     0.056                                  61
                                                      0.056 + 0.038*                             49
                                                            0.6                                  95
                                                       0.45 + 0.45*                              88
                                                            1.1                                  90
                                                        1.1 + 0.8*                               90
 Chrysoperla      larvae            SL18                               mortality,         Corr.       red. of c.   30 %
 carnea                                                                fecundity         mort. (%)    repro (%)
                                                           0.04                             20            6.3
 *:interval 13                                         0.04 + 0.04*                          9            54
 days                                                     0.075                             58            49
                                                      0.075 + 0.05*                         58            40
                                                            0.8                             64            79
                                                        0.8 + 0.8*                          67            77
                                                            1.5                             84            55
                                                         1.5 + 1*                           69            77
 Chrysoperla      larvae            SL14                               mortality,         Corr.       red. of c.   30 %
 carnea                                                                fecundity         mort. (%)    repro (%)
                                                           0.03                             38             0
 *:interval 10                                         0.02 + 0.02*                         21            35
 days                                                     0.056                             61            63
                                                      0.056 + 0.04*                         59            80
                                                            0.6                             66            85
                                                       0.45 + 0.45*                         74            45
                                                            1.1                             89            77
                                                        1.1 + 0.8*                          77            78
 Orius            nymphs            SL18                               mortality          Corr.       red. of c.   30 %
 laevigatus                                                                              mort. (%)    repro (%)
                                                           0.04                             22            23
 *:interval 10                                         0.03 + 0.03*                         12            52
 days                                                     0.075                             28            38
                                                       0.075 + 0.05*                        15            14
                                                            0.8                             12            30
                                                        0.6 + 0.6*                          27            34
                                                            1.5                             21            23
                                                         1.5 + 1*                           16            34
 Orius            nymphs            SL14                               mortality          Corr.       red. of c.   30 %
 laevigatus                                                                              mort. (%)    repro (%)
                                                           0.03                             22            23
 *:interval 10                                         0.02 + 0.02*                         12            52
 days                                                     0.056                             28            38
                                                       0.056 + 0.04*                        15            14
                                                            0.6                             12            30
                                                       0.45 + 0.45*                         27            34
                                                            1.1                             21            23
                                                        1.1 + 0.8*                          16            34

off-crop assessment

 Field tests
 The results from Oellrich et al, 2000a, performed under realistic worst case conditions for the transgenic maize scenario,
 indicate that the treatments with Liberty SL18 at 2 x 0.8 kg as/ha will cause effects on a number of non-target arthropod
 species in the treated field. For the majority of the affected species, however, recovery can be expected in a few weeks. For
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                                            GLUFOSINATE-AMMONIUM
                                               Volume 1 - Level 4
 the dominant species of leaf-dwelling spiders, time to recovery was longer, 2 – 3 months. Also in supplementary studies,
 spiders were shown to be a sensitive group. In a study with autumn treatment with Liberty, the effects remained until the
 next season. The most sensitive species from laboratory data, predatory mites, were not included in the field studies.

 Field test in orchards is ongoing.

Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6)
 Acute toxicity                                               14 days LC50 >1000 mg/kg dw for a.s.
                                                              14 days LC50 >1000 mg/kg dw for MPP
                                                              14 days LC50 >760 mg/kg dw for MPA
                                                              14 days LC50 >300 mg/kg dw for NAG
                                                              14 days LC50 >1000 mg/kg dw for SL18 formulation
                                                              14 days LC50 >1000 mg/kg dw for SL14 formulation
 Reproductive toxicity                                        Not required.


Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)
     Application rate                   Crop                     Time-scale               TERST                Annex VI
        (kg as/ha)                                                                                              Trigger
 1.5 + 1.0                  apple orchard                    14 days               >500 for GA            10
                                                                                   >1390 for MPP          10
 30 days interval                                                                  >2110 for MPA          10
 0.8 + 0.8                  GMO maize                        14 days               >625 for GA            10
                                                                                   >1750 for MPP          10
 10 days interval                                                                  >2620 for MPA          10
                                                                                   >375 for NAG           10
 0.6                        potatoes                         14 days               >1250 for GA           10
                                                                                   >3450 for MPP          10
                                                                                   >5430 for MPA          10




Effects on soil micro-organisms (Annex IIA, point 8.5, Annex IIIA, point 10.7)
 Nitrogen mineralization                                      Less than 25% effect for parent and metabolites at 1x
                                                              field rate. Only transient effects at appr. 10 x field rate.
 Carbon mineralization                                        Less than 25% effect for parent and metabolites at 1x
                                                              field rate. Only transient effects at appr. 10 x field rate.

				
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