observed at the maternally toxic dose by 1L72T6

VIEWS: 14 PAGES: 14

									                                                                 ADVICE SUMMARY
                                    APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT
Product name:               RANCONA C SEED TREATMENT
Applicant:                  CHEMTURA AUSTRALIA PTY LTD
Product number:             63309
Application number:         45294

Purpose of Application and Description of Use: Registration of a 20 g/L ipconazole and 4 g/L cypermethrin, microemulsion product for control of smut
                       and bunt diseases in cereals, in conjunction with the approval of new active ipconazole.

Active Constituent(s):      CYPERMETHRIN
                            IPCONAZOLE

Regulatory Decision:
To grant the application subject to the following conditions:

Standard Conditions of Registration/Approval
    1.   Containers must meet AgVet Code Regulation 18
    2.   Agricultural products must meet Active Constituents Quality Assurance Requirements
    3.   Label must contain a Date of Manufacture and Batch Number
For full conditions, refer to http://www.apvma.gov.au/advice_summaries/adv_summaries.shtml.




45294                                                                    Page 1 of 14                                     KP25S_F39 Version: 2 Issued: 14/08/2007
ADVICE
Australian Government Department of Health and Ageing, Office of Chemical Safety and Environmental Health


Chemtura Australia Pty Ltd has supplied comprehensive toxicological studies on ipconazole, including toxicokinetics and metabolism, acute toxicity, short-term, subchronic and chronic
(carcinogenicity) studies. Genotoxicity, developmental, reproductive and neurotoxicity studies were supplied. Ipconazole belongs to the triazole-containing class of chemicals and is structurally
similar to many other triazole compounds used as pesticides. Ipconazole exerts its effect by inhibiting sterol synthesis in fungi.

The toxicology studies were conducted in accordance with contemporary test guidelines. The data provided in the acute and repeat dose studies were relied on by the OCSEH in considering
whether the proposed use of the product would not be an undue health hazard to public.

Based on the findings of the acute toxicological studies evaluated, the active has low to moderate oral toxicity, low dermal and inhalational toxicity, is not a skin irritant, is a moderate eye
irritant, but not a skin sensitiser in guinea pigs.

Systemic effects in mice, rats, rabbits and dogs following exposure to ipconazole included decreased body weight, and body weight gain and food consumption. Liver effects were common in
rodents and dogs, and ocular effects were also observed in dogs. Developmental effects were only observed at the maternally-toxic dose, and are considered a non-specific secondary
consequence of such. Ipconazole is not likely to be a human carcinogen, and there is no concern for mutagenicity (in vitro) or genotoxicity (in vitro and in vivo).

Based on the findings of toxicological studies evaluated, the product has low acute oral, dermal and inhalational toxicity. It is a slight eye irritant, but not a skin irritant or skin sensitiser.
Personal protective equipment for workers has been recommended based on acute and repeat dose risk assessments. As the product is to be used for seed treatment there was no need for
assessing re-entry exposure.

Ipconazole is not intended for direct application to food producing crops, but simply as a seed treatment. However, an ADI has been set so as to generate a maximum residues level (MRL). An
ADI for ipconazole was established at 0.015 mg/kg bw/day based on a NOEL of 1.5 mg/kg bw/day in a 1-year chronic toxicity study in the most sensitive species, the dog, and using a 100-fold
safety factor.

No ARfD is required to be established at this time, as ipconazole is not considered likely to present an acute hazard (including developmental toxicity) to humans.

At its 57th Meeting in October 2009 the National Drug and Poisons Scheduling Committee (NDPSC) decided that the toxicity profile of ipconazole clearly warranted a Schedule 6 parent entry
in the Standard for the Uniform Scheduling of Drugs and Poisons, particularly the acute oral and inhalation toxicity and eye irritancy potential, with a cut-off to Schedule 5 for preparations
containing 2 percent or less of ipconazole.

The toxicology data and other information on the product provided and considered in this assessment justify the Safety Directions established in the present evaluation. The recommendations in
regard to the safety directions, first aid instructions and signal heading have been included on the label. The OCSEH therefore supported the registration of the proposed use of Rancona C
Seed Treatment and recommended that the proposed product will not be an undue health hazard to humans.




45294                                                                                           Page 2 of 14                                                            KP25S_F39 Version: 2 Issued: 14/08/2007
Data relied on to provide the advice
                                                                                                                                                                                   Inherited
Data No   Data            Author(s)                                    Title                             Date     Data Type         Data Sub-type              Authorising        Application
          Source                                                                                                                                                 Party                No.
          *
23215     S        Takeda, K          Acute Dermal Toxicity Study of KNF-317 in Rats                    1989    Toxicology    Acute Dermal Studies,         Kureha
                                                                                                                              Active                        Corporation
23216     S        Suzuki, A          Acute Inhalation Toxicity Study of KNF-317 Technical in           1991    Toxicology    Acute Inhalation Studies,     Kureha
                                      Rats                                                                                    Active                        Corporation
23217     S        Takeda, K          Acute Oral Toxicity Study of KNF-317 in Mice                      1989    Toxicology    Acute Oral Studies,           Kureha
                                                                                                                              Active                        Corporation
23218     S        Takeda, K.         Acute Oral Toxicity Study of KNF-317 in Rats                      1989    Toxicology    Acute Oral Studies,           Kureha
                                                                                                                              Active                        Corporation
23222     S        Nishitomi, T.      Bacterial DNA Repair Study of KNF-317                             1989    Toxicology    Genotoxicity                  Kureha
                                                                                                                              (Mutagenicity) Studies        Corporation
23223     S        Nishitomi, T       Bacterial Reverse Mutation Study of KNF-317                       1989    Toxicology    Genotoxicity                  Kureha
                                                                                                                              (Mutagenicity) Studies        Corporation
23225     S        Cifone, M, A.      CHO HGPRT Forward Mutation Assay With Duplicate                   2001    Toxicology    Genotoxicity                  Applicant
                                      Culture of Ipconazole                                                                   (Mutagenicity) Studies
23226     S        Nishitomi, T.      Chromosomal Aberration Study of KNF-317 in Cultured               1989    Toxicology    Genotoxicity                  Kureha
                                      Mammalian Cells                                                                         (Mutagenicity) Studies        Corporation
23288     S        Hoffman, G.M       Ipcoanzole technical: An Acute (4-hour) Inhalation Toxicty        2003    Toxicology    Acute Inhalation Studies,     Applicant
                                      Study in the Rat via Nose-Only Exposure                                                 Active
23294     S        Cooper, S          Ipconazole combined carcinogenicity and chronic toxicity          2006    Toxicology    Chronic/Carcinogenicity       Kureha
                                      study by dietary administration to Han Wistar rats for 104                              Studies                       Corporation
                                      weeks
23298     S        Cooper, S          Ipconazole preliminary toxicity study by dietary                  2005    Toxicology    Sub-chronic Studies           Kureha
                                      administration to CD-1 mice for 13 weeks                                                                              Corporation
23302     S        Cooper, S          Ipconazole toxicity study by dietary administration to Han        2004    Toxicology    Sub-chronic Studies           Kureha
                                      Wistar rats for 13 weeks                                                                                              Corporation
23307     S        Goldenthal,        Ipconazole: A 28-Day Dermal Toxicity Study In Rats                2006    Toxicology    Short-term Studies            Applicant
                   E.I.
23308     S        Hoffman, G.M.      Ipconazole: A 4-week inhalation toxicity study in the rat via     2006    Toxicology    Short-term Studies            Kureha
                                      nose-only exposure                                                                                                    Corporation
23322     S        Ueda, H            Ipconazole: Dermal Sensitization Study in Guinea Pigs             1997    Toxicology    Acute Skin Sensitisation      Kureha
                                                                                                                              Studies, Active               Corporation
23327     S        Paffett, R.A       Ipconazole: toxicity study by oral capsule administration to      2006    Toxicology    Sub-chronic Studies           Kureha
                                      beagle dogs for 13 weeks                                                                                              Corporation



45294                                                                                    Page 3 of 14                                               KP25S_F39 Version: 2 Issued: 14/08/2007
                                                                                                                                                                                         Inherited
Data No   Data                Author(s)                                 Title                              Date       Data Type           Data Sub-type              Authorising        Application
          Source                                                                                                                                                       Party                No.
          *
23329     S        Armour, G              Ipconazole; preliminary reproductive performance study by          2006   Toxicology    Reproduction Studies            Kureha
                                          dietary administration to Han Wistar rats                                                                               Corporation
23330     S        Cooper, S              Ipconazole; Preliminary Toxicity Study By Dietary                  2004   Toxicology    Short-term Studies              Kureha
                                          Administration to CD-1 Mice for 4 Weeks                                                                                 Corporation
23331     S        Paffett, R.A           Ipconazole; Preliminary Toxicity Study by Oral Capsule             2005   Toxicology    Short-term Studies              Kureha
                                          Administration to Beagle Dogs for 4 Weeks.                                                                              Corporation
23332     S        Paffett, R.A           Ipconazole; toxicity study by oral capsule administration to       2007   Toxicology    Chronic Studies                 Kureha
                                          beagle dogs for 52 weeks                                                                                                Corporation
23333     S        Armour, G              Ipconazole; two generation reproductive performance study          2006   Toxicology    Reproduction Studies            Kureha
                                          by dietary administration to Han Wistar rats                                                                            Corporation
23334     S        Cooper, S              Ipconazole;carcinogenicity study by dietary administration to      2007   Toxicology    Carcinogenicity Studies         Kureha
                                          CD-1 Mice for 78 weeks                                                                                                  Corporation
23335     S        Hatakenaka, N          KNF-317:Teratogenicity Study in Rabbits                            1991   Toxicology    Developmental                   Kureha
                                                                                                                                  (Teratology) Studies            Corporation
23336     S        Kaneda, M              KNF-317:Teratogenicity Study in Rabbits Preliminary Study          1990   Toxicology    Developmental                   Kureha
                                                                                                                                  (Teratology) Studies            Corporation
23337     S        Fujii, S               KNF-317:Teratogenicity Study in Rats                               1990   Toxicology    Developmental                   Kureha
                                                                                                                                  (Teratology) Studies            Corporation
23338     S        Fujii, S               KNF-317:Teratogenicity Study in Rats Preliminary Study             1990   Toxicology    Developmental                   Kureha
                                                                                                                                  (Teratology) Studies            Corporation
23339     S        Cooper, S              KNF-317; Preliminary Toxicity Study by Dietary                     2003   Toxicology    Acute Oral Studies,             Kureha
                                          Adminsitration to Han Wistar Rats for 4 Weeks.                                          Active                          Corporation
23341     S        Pritchard, L           Micronucleus Test of Ipconazole in Mice                            2005   Toxicology    Genotoxicity                    Kureha
                                                                                                                                  (Mutagenicity) Studies          Corporation
23344     S        Oigawa, J              Primary Dermal Irritation Study of Ipconazole in Rabbits           1997   Toxicology    Acute Dermal Studies,           Kureha
                                                                                                                                  Active                          Corporation
23345     S        Oigawa, J              Primary Eye Irritation Study of Ipconazole in Rabbits              1997   Toxicology    Acute Eye Irritation            Kureha
                                                                                                                                  Studies, Active                 Corporation
23350     S        Story, D.L. &          Supplement to Ipconazole Rabbit Teratology Study                   2001   Toxicology    Developmental                   Applicant
                   Kaneda, M.                                                                                                     (Teratology) Studies
23359     S        Griffiths, D.R.        UBI 6918.02 (Dyed Formulation) Acute Inhalation Toxicity           2008   Toxicology    Acute Inhalation Studies,       Applicant
                                          (nose only) in the Rat                                                                  Product
23360     S        Sanders, A             UBI 6918.02 (Dyed Formulation) Acute Toxicity in the Rat -         2008   Toxicology    Acute Oral Studies,             Applicant
                                          Acute Toxic Class Method                                                                Product




45294                                                                                       Page 4 of 14                                                  KP25S_F39 Version: 2 Issued: 14/08/2007
                                                                                                                                                                                                 Inherited
Data No     Data            Author(s)                                  Title                              Date           Data Type                Data Sub-type              Authorising        Application
            Source                                                                                                                                                             Party                No.
            *
23361       S        Sanders, A         UBI 6918.02 (Undyed Formulation) Acute Dermal Irritation            2008     Toxicology          Acute Dermal Studies,            Applicant
                                        in the Rabbit                                                                                    Product
23362       S        Sanders, A         UBI 6918.02 (Undyed Formulation) Acute Dermal Toxicity              2008     Toxicology          Acute Dermal Studies,            Applicant
                                        (Limit Test) in the Rat                                                                          Product
23363       S        Sanders, A         UBI 6918.02 (Undyed Formulation) Acute Eye Irritation in            2008     Toxicology          Acute Eye Irritation             Applicant
                                        the Rabbit                                                                                       Studies, Product
23364       S        Richeux, F         UBI 6918.02 (Undyed Formulation) Skin Sensitisation in the          2008     Toxicology          Acute Skin Sensitisation         Applicant
                                        Guinea Pig - Magnusson and Kligman Maximisation Method                                           Studies, Product




Australian Government Department of Environment, Water, Heritage and the Arts

The Department of the Environment, Water, Heritage and the Arts (DEWHA) has assessed the data submitted in support of the application for registration and has concluded that the risks to the
environment from the proposed use are acceptable.
While ipconazole is hydrolytically stable in aqueous solution, and is also relatively stable in soils under all laboratory conditions, aqueous photolysis is a significant degradation pathway for
ipconazole.. Field dissipation studies show that ipconazole dissipates relatively rapidly in the field under normalised moisture and temperature conditions, but dissipates more slowly under drier
conditions. Ipconazole has a moderate potential for bioaccumulation in fish. However, rapid depuration occurred once exposure ceased.
Ipconazole is slightly toxic to northern bobwhite quail and moderately toxic to terrestrial mammals, slightly toxic to earthworms and very slightly toxic to worker bees. It is also not considered
to have a long-term effect on soil micro-organisms. Ipconazole is considered moderately toxic to fish, aquatic invertebrates and algae, but practically non-toxic to sludge micro-organisms.
The risk to aquatic species is considered acceptable based on the results of runoff modeling and the use pattern as a seed treatment. Risk to terrestrial organisms was assessed based on the
available endpoints and the proposed application rate of the product. The assessment concludes that the risk from the proposed use of the product will be acceptable to terrestrial organisms
provided the instructions on the label are followed.
The APVMA has considered the findings of the DEWHA and accepts these conclusions




45294                                                                                      Page 5 of 14                                                           KP25S_F39 Version: 2 Issued: 14/08/2007
Data relied on to provide the advice
                                                                                                                                                                                     Inherited
Data No   Data            Author(s)                                    Title                             Date     Data Type         Data Sub-type                Authorising        Application
          Source                                                                                                                                                   Party                No.
          *
23211     S        Wanner, U.         [4C]-Ipconazole: Adsorption/desorption to a loamy sand            2006    Environment   Mobility                        Applicant
                                      (batch equilibrium method)                                                Fate          Adsorption/Desorption
23212     S        Hatzenbeler        A hydrolysis study of [14C]Ipconazole in water                    2001    Environment   Physicochemical                 Applicant
                   C.J. and Long,                                                                               Fate          Degradation Hydrolysis
                   M.C.
23214     S        J.F. Shah, M.S.    A photolysis study of [14C]Ipconazole in water                    2001    Environment   Physicochemical                 Applicant
                                                                                                                Fate          Degradation
                                                                                                                              Photodegradation
23219     S        Hatzenbeler        Adsorption and desorption of [14C]Ipconazole in soils             2001    Environment   Mobility                        Applicant
                   C.J. & Long,                                                                                 Fate          Adsorption/Desorption
                   M.C.
23220     S        Hatzenbeler        An aged column leaching study of [14C]Ipconazole                  2001    Environment   Mobility Leaching               Applicant
                   C.J. & Repko,                                                                                Fate          Potential
                   T.
23224     S        Saishoji, T        Biological Activities of Ipconazole Isomers                       2007    Environment   Other Information               Kureha
                                                                                                                Toxicology                                    Corporation
23287     S        Schocken, M.J.     Gas-phase oxidation rate and half-life of ipconazole in the       2003    Environment   Field Dissipation Air           Applicant
                                      troposphere                                                               Fate
23289     S        Shaw, D            Ipconazole aerobic transformation in aquatic sediment             2005    Environment   Biodegradation Soils            Kureha
                                      systems                                                                   Fate                                          Corporation
23290     S        Flatman, D         Ipconazole Algal Growth Inhibition Assay                          2006    Environment   Aquatic Organisms Other         Kureha
                                                                                                                Toxicology                                    Corporation
23291     S        Mellor, S.J        Ipconazole anaerobic soil route and rate of degradation           2006    Environment   Biodegradation Soils            Kureha
                                                                                                                Fate                                          Corporation
23292     S        Barnes, S.P.       Ipconazole assessment of ready biodegradability - Modified        2005    Environment   Biodegradation Soils            Kureha
                                      Sturm Test                                                                Fate                                          Corporation
23293     S        Knight, L          Ipconazole Bioconcentration in Bluegill Sunfish                   2006    Environment   Aquatic Organisms Other         Kureha
                                                                                                                Toxicology                                    Corporation
23295     S        Carter, J.N.       Ipconazole Effects on Soil Non-Target Micro-organisms:            2005    Environment   Non-target Invertebrates        Kureha
                                      Nitrogen Transformation Carbon Transformation                             Toxicology    (terrestrial) Soil Micros       Corporation
23296     S        Burke, J           Ipconazole Fish Early Life Stage Toxicity Test for Fathead        2007    Environment   Aquatic Organisms Other         Kureha
                                      Minnow                                                                    Toxicology                                    Corporation




45294                                                                                    Page 6 of 14                                                 KP25S_F39 Version: 2 Issued: 14/08/2007
                                                                                                                                                                                   Inherited
Data No   Data            Author(s)                                 Title                            Date       Data Type           Data Sub-type              Authorising        Application
          Source                                                                                                                                                 Party                No.
          *
23297     S        Shaw, D             Ipconazole metabolic fate in soil under aerobic conditions      2005   Environment   Biodegradation Soils            Kureha
                                                                                                              Fate                                          Corporation
23299     S        Flatman, D          Ipconazole Prolonged Toxicity to Daphia magna                   2007   Environment   Aquatic Organisms Other         Kureha
                                                                                                              Toxicology                                    Corporation
23300     S        Shaw, D             Ipconazole rate of degradation in three aerobic soils           2005   Environment   Biodegradation Soils            Kureha
                                                                                                              Fate                                          Corporation
23301     S        Shaw, D             Ipconazole Soil Photolysis                                      2005   Environment   Physicochemical                 Kureha
                                                                                                              Fate          Degradation                     Corporation
                                                                                                                            Photodegradation
23303     S        Flatman, D          Ipconazole Toxicity to the Sediment-Dwelling Phase of           2006   Environment   Aquatic Organisms Acute         Kureha
                                       the Midge (Chironomus riparius)                                        Toxicology                                    Corporation

23309     S        Palmer, S.J. &      Ipconazole: A 48-hour Flow-Through Acute Toxicity               2001   Environment   Aquatic Organisms Acute         Applicant
                   Kendall, T.Z. &     Test with the Cladoceran (Daphnia magna)                               Toxicology
                   Krueger, H.O.
23310     S        Palmer, S.J. &      Ipconazole: A 96-hour Flow-Through Acute Toxicity               2001   Environment   Aquatic Organisms Acute         Applicant
                   Kendall, T.Z. &     Test with the Bluegill (Lepomis macrochirus)                           Toxicology
                   Krueger, H.O.
23311     S        Palmer, S.J. &      Ipconazole: A 96-hour Flow-Through Acute Toxicity               2001   Environment   Aquatic Organisms Acute         Applicant
                   Kendall, T.Z. &     Test with the Rainbow Trout (Oncorhynchus mykiss)                      Toxicology
                   Krueger, H.O.
23312     S        Gallagher, S.P, &   Ipconazole: A Dietary LC50 Study with the Mallard               2000   Environment   Vertebrates Acute               Applicant
                   Beavers, J.B.&                                                                             Toxicology
                   Martin, K.H.
23313     S        Gallagher, S.P, &   Ipconazole: A Dietary LC50 Study with the Northern              2000   Environment   Vertebrates Acute               Applicant
                   Beavers, J.B.&      Bobwhite                                                               Toxicology
                   Martin, K.H.
23314     S        Temple, D.L. &      Ipconazole: A Pilot Reproduction Study with Northern            2002   Environment   Vertebrates Other               Applicant
                   Martin, K.H. &      Bobwhite                                                               Toxicology
                   Beavers, J.B.
23315     S        Temple, D.L. &      Ipconazole: A Pilot Reproduction Study with the Mallard         2002   Environment   Vertebrates Other               Applicant
                   Martin, K.H. &                                                                             Toxicology
                   Beavers, J.B.




45294                                                                                 Page 7 of 14                                                  KP25S_F39 Version: 2 Issued: 14/08/2007
                                                                                                                                                                                  Inherited
Data No   Data            Author(s)                              Title                              Date       Data Type           Data Sub-type              Authorising        Application
          Source                                                                                                                                                Party                No.
          *
23316     S        Temple, D.L. &      Ipconazole: A Reproduction Study with Northern                 2003   Environment   Vertebrates Other               Applicant
                   Grimes, J. &        Bobwhite                                                              Toxicology
                   Martin, K.H. &
                   Beavers, J.B. &
                   Jaber, M.
23317     S        Temple, D.L. &      Ipconazole: A Reproduction Study with the Mallard              2003   Environment   Vertebrates Other               Applicant
                   Grimes, J. &                                                                              Toxicology
                   Martin, K.H. &
                   Beavers, J.B. &
                   Jaber, M.
23318     S        Barnes, S.P.        Ipconazole: Activated Sludge - Respiration Inhibition          2006   Environment   Other Information               Kureha
                                       Test                                                                  Toxicology                                    Corporation
23319     S        Rodgers, M.H.       Ipconazole: Acute Toxicity (LC50) to the Earthworm             2005   Environment   Non-target Invertebrates        Kureha
                                                                                                             Toxicology    (terrestrial) Earthworms        Corporation

23320     S        Taylor, K           Ipconazole: Acute Toxicity to Honey Bees (Apis                 2005   Environment   Non-target Invertebrates        Kureha
                                       mellifera)                                                            Toxicology    (terrestrial) Bees              Corporation
23321     S        Gallagher, S.P, &   Ipconazole: An Acute Oral Toxicity Study with the              2000   Environment   Vertebrates Acute               Applicant
                   Beavers, J.B.       Northern Bobwhite                                                     Toxicology
23326     S        Rodgers, M.H.       Ipconazole: To Determine the Effects on Reproduction           2006   Environment   Non-target Invertebrates        Kureha
                                       and Growth of the Earthworm, Eisenia foetida                          Toxicology    (terrestrial) Earthworms        Corporation
23328     S        Darriet, M. et.al   Ipconazole; Kinetic assessment of the EU field soil            2007   Environment   Field Dissipation Soils         Applicant
                                       dissipation studies - seed treatment trials                           Fate




45294                                                                                Page 8 of 14                                                  KP25S_F39 Version: 2 Issued: 14/08/2007
APVMA Pesticides Program, Residues Team

The APVMA Pesticides Residues Section has evaluated the available metabolism, residue trials, analytical methodology, fate in storage, processing data and residues in trade issues, including
that submitted by Chemtura Australia Pty Ltd to support their application, to assess whether this product is an undue hazard to the safety of consumers exposed to its residues, and further to
determine whether there is any undue prejudice to Australia’s trade of treated commodities. The Pesticides Residues Section has considered the product when used in accordance with the
proposed label instructions. The product will be used as a seed treatment before sowing the crop. The APVMA Residues section has evaluated the residues aspects of the proposed product and
recommended amendments to the MRL standard for ipconazole and for inclusion in the Food Standards Code. The APVMA is satisfied that the proposed use of Rancona C Seed Treatment
will not be an undue hazard to the safety of people using anything containing its residues. Recommendations in regard to the required withholding period and protection statements for Livestock
and others have been included on the label. The APVMA is satisfied that the proposed use of Rancona C Seed Treatment would not adversely affect trade between Australia and places outside
Australia as the product is not for use in animals producing any major Australian export commodities.

Data relied on to provide the advice
                                                                                                                                                                                             Inherited
Data No    Data             Author(s)                                   Title                               Date           Data Type              Data Sub-type           Authorising       Application
           Source                                                                                                                                                           Party               No.
           *
23213      S        Kimmel, E.C                A metabolism study with [14C-triazolyl] ipconazole         2003      Metabolism and            Plants                    Applicant
                                               in peanuts                                                           Kinetics
23253      S        Frost, W                   Determination of Residues of Ipconazole in Cereal          2008      Residues                  Crop Residues             Applicant
                                               Forage, Straw and Seed Following Application of                                                Human
                                               UBI 6918.00 to Wheat, Barley and Oats Seed, One                                                Consumption
                                               Study - Australia
23257      S        Fathulla, R.N              Determination of the total radioactive residues of         2001      Metabolism and            Plants                    Applicant
                                               14C-labelled ipconazole in canola                                    Kinetics

23258      S        Fathulla, R.N              Determination of the total radioactive residues of         2001      Metabolism and            Plants                    Applicant
                                               14C-labelled ipconazole in carrot                                    Kinetics
23259      S        Fathulla, R.N              Determination of the total radioactive residues of         2000      Metabolism and            Plants                    Applicant
                                               14C-labelled ipconazole in corn                                      Kinetics
23260      S        Fathulla, R.N              Determination of the total radioactive residues of         2001      Metabolism and            Plants                    Applicant
                                               14C-labelled ipconazole in cotton                                    Kinetics
23261      S        Fathulla, R.N              Determination of the total radioactive residues of         2001      Metabolism and            Plants                    Applicant
                                               14C-labelled ipconazole in cucumbers                                 Kinetics




45294                                                                                      Page 9 of 14                                                       KP25S_F39 Version: 2 Issued: 14/08/2007
                                                                                                                                                                               Inherited
Data No   Data              Author(s)                            Title                               Date          Data Type       Data Sub-type            Authorising       Application
          Source                                                                                                                                              Party               No.
          *
23262     S        Fathulla, R.N        Determination of the total radioactive residues of         2000      Metabolism and    Plants                     Applicant
                                        14C-labelled ipconazole in leaf lettuce                              Kinetics
23263     S        Fathulla, R.N        Determination of the total radioactive residues of         2001      Metabolism and    Plants                     Applicant
                                        14C-labelled ipconazole in sorghum                                   Kinetics
23264     S        Fathulla, R.N        Determination of the total radioactive residues of         2001      Metabolism and    Plants                     Applicant
                                        14C-labelled ipconazole in soybean                                   Kinetics
23265     S        Fathulla, R.N        Determination of the total radioactive residues of         2001      Metabolism and    Plants                     Applicant
                                        14C-labelled Ipconazole in Wheat                                     Kinetics


23272     S        Banijamali, A.R.     Distribution and metabolism of [14C-                       2006      Metabolism and    Plants                     Applicant
                                        Triazolyl]Ipconazole and [14C-                                       Kinetics
                                        Benzylmethylene]Ipconazole used as a seed
                                        treatment for spring wheat
23273     S        Gay, M.H             Distribution and metabolism of [Triazole-3,5-14C]-         2002      Metabolism and    Plants                     Applicant
                                        Ipconazole used as a seed treatment for winter wheat                 Kinetics
23323     S        Knight, L            Ipconazole: Metabolism in rats                             2007      Metabolism and    Laboratory Animals         Kureha
                                                                                                             Kinetics                                     Corporation
23324     S        Haynes, L.M.         Ipconazole: Metabolism in the lactating goat               2007      Metabolism and    Laboratory Animals         Kureha
                                                                                                             Kinetics                                     Corporation
23325     S        Wang, R.             Ipconazole: Nature of the residue in soybean grain,        2001      Metabolism and    Plants                     Applicant
                                        soybean hay and wheat grain                                          Kinetics
35857     S        D Airs               IPCONAZOLE VALIDATION OF                                   3rd       Residues          Crop Residues              Applicant
                                        METHODOLOGY FOR THE DETERMINATION                          Decemb                      Livestock Feed
                                        OF RESIDUES IN BOVINE TISSUES (LIVER,                      er 2009
                                        KIDNEY, FAT AND MUSCLE), MILK AND IN
                                        CHICKEN EGGS
35858     S        Norman McLean,       Determination of Ipconazole, Triazolylalanine,             Decemb    Residues          Other Information          Applicant
                   Enviro-Test          Triazolylacetic acid and Triazolylpyruvate in Wheat        er 21,
                   Laboratories         and Maize (Plant, Grain and Straw)                         2006




45294                                                                              Page 10 of 14                                                KP25S_F39 Version: 2 Issued: 14/08/2007
External Efficacy Reviewer
An appropriate evaluation program comprising 32 field trials and a glasshouse trial was conducted in four Australian States – NSW (8) including northern NSW (3), Victoria (4), South
Australia (3) and Western Australia (17) were conducted to determine the efficacy of Rancona C Seed Treatment on the control of seed-borne bunt and smut diseases of cereals (wheat, barley,
oats) and to evaluate the safety on the target crops. The replicated experiments were conducted and reported according to an appropriately high standard of scientific investigation, including the
use of statistical designs and analyses that were sufficiently robust to determine meaningful treatment effects.

The information available and the results from each set of trials were adequately and accurately presented and summarized by the applicant. Overall, the performance of Rancona C Seed
Treatment, which was always applied as a seed treatment prior to sowing, was consistent in terms of both efficacy and crop selectivity (safety) across the experimental sites and years. At the rate
recommended (100 mL/100 kg seed), the fungicide generally provided excellent to complete control (90-100%) of the cereal bunts/smuts in the heads of infected crops. Likewise, it was
demonstrated that Rancona C Seed Treatment consistently produced no signs of crop injury with wheat or barley, either at emergence, during the growth phase or at harvest. Two oat varieties
showed slight but acceptable emergence or seedling effects in response to double the recommended rate – as a consequence, the directions for use section stressed the importance of using the
recommended application rate (100 mL/100 kg seed).

Hence, in terms of the evidence for the efficacy of the product and its safety to target and non-target species, the reviewer recommended that the registration of Rancona C Seed Treatment be
supported.

Data relied on to provide the advice
                                                                                                                                                                                                Inherited
Data No     Data            Author(s)                                      Title                                 Date             Data Type           Data Sub-type         Authorising        Application
            Source                                                                                                                                                            Party                No.
            *
23207       S        Holloway G                 2005 Evaluation of fungicide seed treatment (A1556           2006          Efficacy and Safety       Efficacy            Applicant
                                                FS) efficacy against bunt (Tilletia spp.) in wheat.
23208       S        Holloway G                 2006 Evaluation of fungicide seed treatment (A1556           2007          Efficacy and Safety       Efficacy            Applicant
                                                ME) efficacy against bunt (Tilletia spp.) in wheat.
23209       S        Holloway, G.               2006 Evaluation of fungicide seed treatment (A1556           2007          Efficacy and Safety       Efficacy            Applicant
                                                ME) efficacy against covered smut (Ustilago spp.) in
                                                barley.
23210       S        Holloway G                 2007 Evaluation of fungicide seed treatment (A1556           2008          Efficacy and Safety       Efficacy            Applicant
                                                ME) efficacy against covered smut (Ustilago spp.) in
                                                barley.
23227       S        McVeigh V                  Comparison of seed dressing fungicides for the control       2005          Efficacy and Safety       Efficacy            Applicant
                                                of loose smut (Ustilago nuda) in barley cv Stirling.
                                                Northam, Western Australia, 2005.

23228       S        McVeigh V                  Comparison of seed dressing fungicides for the control       2005          Efficacy and Safety       Efficacy            Applicant
                                                of loose smut (Ustilago nuda) in barley cv Stirling.
                                                Walla Walla, New South Wales, 2005.




45294                                                                                      Page 11 of 14                                                         KP25S_F39 Version: 2 Issued: 14/08/2007
                                                                                                                                                                        Inherited
Data No   Data           Author(s)                             Title                             Date        Data Type         Data Sub-type        Authorising        Application
          Source                                                                                                                                      Party                No.
          *
23229     S        McVeigh V         Comparison of seed treatments for the control of          2007     Efficacy and Safety   Efficacy           Applicant
                                     covered smut (Ustilago hordei) in barley cv Baudin.
                                     Northam, Western Australia, 2006.
23230     S        McVeigh V         Comparison of seed treatments for the control of          2007     Efficacy and Safety   Efficacy           Applicant
                                     covered smut (Ustilago hordei) in barley cv Stirling.
                                     Northam, Western Australia, 2006.
23231     S        McVeigh V         Comparison of seed treatments for the control of loose    2007     Efficacy and Safety   Efficacy           Applicant
                                     smut (Ustilago nuda) in barley cv Stirling. Northam,
                                     Western Australia, 2006.
23232     S        McVeigh, V.       Comparison of seed treatments for the control of loose    2007     Efficacy and Safety   Efficacy           Applicant
                                     smut (Ustilago tritici) in wheat cv Carnamah. Northam,
                                     Western Australia, 2006
23233     S        McVeigh V         Comparison of seed treatments for the control of seed     2007     Efficacy and Safety   Efficacy           Applicant
                                     and soil-borne flag smut (Urocystis agropyri) in wheat
                                     cv Eradu. South Bodallin, Western Australia, 2007.
23234     S        McVeigh, V        Comparison of seed treatments for the control of seed-    2007     Efficacy and Safety   Efficacy           Applicant
                                     borne flag smut (Urocystis agropyri) in wheat cv Eradu.
                                     Northam, Western Australia, 2006.
23235     S        McVeigh, V.       Comparison of seed treatments for the control of seed-    2007     Efficacy and Safety   Efficacy           Applicant
                                     borne flag smut (Urocystis agropyri) in wheat cv Eradu.
                                     South Bodallin, Western Australia, 2006.
23236     S        McVeigh, V        Comparison of seed treatments for the control of seed-    2007     Efficacy and Safety   Efficacy           Applicant
                                     borne flag smut (Urocystis agropyri) in wheat cv Eradu.
                                     Toodyay, Western Australia, 2006.
23237     S        McVeigh V         Comparison of seed treatments for the control of seed-    2007     Efficacy and Safety   Efficacy           Applicant
                                     borne flag smut (Urocystis agropyri) in wheat cv Eradu.
                                     Toodyay, Western Australia, 2007.
23238     S        McVeigh V         Comparison of seed treatments for the control of seed-    2007     Efficacy and Safety   Efficacy           Applicant
                                     borne loose and covered smut (Ustilago segetum var.
                                     hordei & U. avenae) in oats cv Yarran. Toodyay,
                                     Western Australia, 2007.
23239     S        Sumner M          Comparison of seed treatments for the control of seed-    2007     Efficacy and Safety   Efficacy           Applicant
                                     borne loose smut (Ustilago tritici) and seed-borne bunt
                                     (Tilletia laevis & T. tritici) in wheat cv Carnamah.
                                     Toodyay, Western Australia, 2007.




45294                                                                          Page 12 of 14                                             KP25S_F39 Version: 2 Issued: 14/08/2007
                                                                                                                                                                                       Inherited
Data No   Data           Author(s)                             Title                               Date          Data Type              Data Sub-type              Authorising        Application
          Source                                                                                                                                                     Party                No.
          *
23240     S        McVeigh, V.          Comparison of seed treatments for the control of seed-            2007    Efficacy and Safety    Efficacy               Applicant
                                        borne loose smut (Ustilago tritici) in wheat cv Carnamah.
                                        Toodyay, Western Australia, 2007. Report number CTA
                                        020-07.
23241     S        McVeigh, V           Comparison of seed treatments for the control of soil-            2007    Efficacy and Safety    Efficacy               Applicant
                                        borne flag smut (Urocystis agropyri) in wheat cv Eradu.
                                        South Burracoppin, Western Australia, 2006.
23242     S        McVeigh V            Comparison of seed treatments for the control of soil-            2007    Efficacy and Safety    Efficacy               Applicant
                                        borne flag smut (Urocystis agropyri) in wheat cv Eradu.
                                        South Burracoppin, Western Australia, 2007.
23274     S        Butt M & Wallwork,   Evaluate A1556ME for control of oat smut.                         2007    Efficacy and Safety    Efficacy               Applicant
                   H
23275     S        Adams K              Evaluation of A1556 for the control of flag smut in wheat.        2008    Efficacy and Safety    Efficacy               Applicant
                                        One small plot field trial. Garah, New South Wales, 2007.
23276     S        Adams K              Evaluation of A1556 for the control of flag smut in wheat.        2008    Efficacy and Safety    Efficacy               Applicant
                                        One small plot field trial. Moree, New South Wales,
                                        2007.
23277     S        Adams K              Evaluation of A1556 for the control of loose smut in              2007    Efficacy and Safety    Efficacy               Applicant
                                        barley. One small plot field trial. Redbanks, South
                                        Australia, 2006.
23278     S        Sumner M             Evaluation of seed dressing fungicides for the control of         2005    Efficacy and Safety    Efficacy               Applicant
                                        loose smut (Ustilago tritici) in wheat cv Carnamah.
                                        Northam, Western Australia, 2005.
23279     S        Sumner M             Evaluation of seed dressing fungicides for the control of         2006    Efficacy and Safety    Efficacy               Applicant
                                        seed borne bunt (Tilletia foetida & T. caries) in wheat cv.
                                        Eradu. Northam, Western Australia, 2005
23280     S        Adams K              Evaluation of the efficacy and crop safety of A1556 when          2005    Efficacy and Safety    Efficacy               Applicant
                                        used as a seed treatment for the control of bunt of wheat.
                                        One small plot field trial, Barry, New South Wales, 2004-
                                        2005.
23281     S        Adams K              Evaluation of the efficacy and crop safety of A1556 when          2005    Efficacy and Safety    Efficacy               Applicant
                                        used as a seed treatment for the control of bunt of wheat.
                                        One small plot field trial, Cargo, New South Wales, 2004-
                                        2005.




45294                                                                              Page 13 of 14                                                        KP25S_F39 Version: 2 Issued: 14/08/2007
                                                                                                                                                                                     Inherited
Data No   Data          Author(s)                            Title                               Date          Data Type              Data Sub-type              Authorising        Application
          Source                                                                                                                                                   Party                No.
          *
23282     S        Adams K             Evaluation of the efficacy and crop safety of A1556 when         2005    Efficacy and Safety    Efficacy               Applicant
                                       used as a seed treatment for the control of covered smut
                                       of barley. One small plot field trial. Barry, New South
                                       Wales, 2004-2005.
23283     S        Adams K             Evaluation of the safety of A1556 to a range of wheat,           2008    Efficacy and Safety    Phytotoxicity          Applicant
                                       barley and oat varieties when applied as a seed treatment                                       and Crop
                                       3-4 weeks prior to planting. One trial, Narrabri, New                                           Safety
                                       South Wales, Australia, 2007.
23284     S        Adams K             Evaluation of the safety of A1556 to a range of wheat,           2008    Efficacy and Safety    Phytotoxicity          Applicant
                                       barley and oat varieties when applied as a seed treatment                                       and Crop
                                       3-4 weeks prior to planting. One trial, Redbanks, South                                         Safety
                                       Australia, Australia, 2007.
23285     S        Adams K             Evaluation of the seed viability of wheat and barley when        2008    Efficacy and Safety    Phytotoxicity          Applicant
                                       treated with A1556 ME in the previous season. One trial,                                        and Crop
                                       Currawarna, New South Wales, Australia, 2007.                                                   Safety




* S = Data submitted with the application
  I = Data inherited (that is, referenced) from another application




45294                                                                            Page 14 of 14                                                        KP25S_F39 Version: 2 Issued: 14/08/2007

								
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