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									CHEMICAL SAFETY REPORT TEMPLATE




                        CHEMICAL SAFETY REPORT




Substance Name:
EC Number:
CAS Number:
Registrant’s identity
                                                                                              CHEMICAL SAFETY REPORT TEMPLATE


                                                                        CONTENTS


1     SUMMARY OF RISK MANAGEMENT MEASURES ................................................................. 7
2     DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED.................. 7
3     DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED .............. 7
1     IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES................. 8
1.1         Name and other identifiers of the substance ......................................................................................................... 8
1.2         Composition of the substance ............................................................................................................................... 8
1.3         Physicochemical properties .................................................................................................................................. 9
2     MANUFACTURE AND USES ................................................................................................. 10
2.1         Manufacture ....................................................................................................................................................... 10
2.2         Identified uses..................................................................................................................................................... 10
2.3         Uses advised against ........................................................................................................................................... 10
3     CLASSIFICATION AND LABELLING .................................................................................... 10
3.1         Classification and labelling in Annex I of Directive 67/548/EEC ...................................................................... 10
3.2         Self classification(s) and labelling ...................................................................................................................... 11
4     ENVIRONMENTAL FATE PROPERTIES ................................................................................ 12
4.1         Degradation ........................................................................................................................................................ 12
    4.1.1       Abiotic degradation ............................................................................................................ 12
      4.1.1.1     Hydrolysis ............................................................................................................................................ 12
      4.1.1.2     Phototransformation/photolysis ........................................................................................................... 12
         4.1.1.2.1 Phototransformation in air ............................................................................................................... 12
         4.1.1.2.2 Phototransformation in water .......................................................................................................... 12
         4.1.1.2.3 Phototransformation in soil ............................................................................................................. 12
    4.1.2       Biodegradation ................................................................................................................... 12
      4.1.2.1     Biodegradation in water ....................................................................................................................... 12
         4.1.2.1.1 Estimated data ................................................................................................................................. 12
         4.1.2.1.2 Screening tests ................................................................................................................................. 12
         4.1.2.1.3 Simulation tests ............................................................................................................................... 12
      4.1.2.2     Biodegradation in sediments ................................................................................................................ 12
      4.1.2.3     Biodegradation in soil .......................................................................................................................... 12
      4.1.2.4     Summary and discussion on biodegradation ........................................................................................ 12
    4.1.3       Summary and discussion on degradation ........................................................................... 12
4.2         Environmental distribution ................................................................................................................................. 13
    4.2.1       Adsorption/desorption ........................................................................................................ 13
    4.2.2       Volatilisation ...................................................................................................................... 13
    4.2.3       Distribution modelling ....................................................................................................... 13
4.3         Bioaccumulation ................................................................................................................................................. 13
    4.3.1       Aquatic bioaccumulation ................................................................................................... 13
    4.3.2       Terrestrial bioaccumulation ............................................................................................... 13
    4.3.3       Summary and discussion of bioaccumulation .................................................................... 13
4.4         Secondary poisoning .......................................................................................................................................... 13
5     HUMAN HEALTH HAZARD ASSESSMENT .......................................................................... 14
5.1         Toxicokinetics (absorption, metabolism, distribution and elimination) ............................................................. 14



                                                                                                                                                                                 1
CHEMICAL SAFETY REPORT TEMPLATE

    5.1.1       Non-human information ..................................................................................................... 14
    5.1.2       Human information ............................................................................................................ 14
    5.1.3       Summary and discussion on toxicokinetics ....................................................................... 14
5.2         Acute toxicity ..................................................................................................................................................... 14
    5.2.1       Non-human information ..................................................................................................... 14
      5.2.1.1            Acute toxicity: oral ............................................................................................................................... 14
      5.2.1.2            Acute toxicity: inhalation ..................................................................................................................... 14
      5.2.1.3            Acute toxicity: dermal .......................................................................................................................... 14
      5.2.1.4            Acute toxicity: other routes .................................................................................................................. 14
    5.2.2       Human information ............................................................................................................ 14
    5.2.3       Summary and discussion of acute toxicity ......................................................................... 14
5.3         Irritation .............................................................................................................................................................. 15
    5.3.1       Skin .................................................................................................................................... 15
      5.3.1.1            Non-human information ....................................................................................................................... 15
      5.3.1.2            Human information .............................................................................................................................. 15
    5.3.2       Eye ..................................................................................................................................... 15
      5.3.2.1            Non-human information ....................................................................................................................... 15
      5.3.2.2            Human information .............................................................................................................................. 15
    5.3.3       Respiratory tract ................................................................................................................. 15
      5.3.3.1            Non-human information ....................................................................................................................... 15
      5.3.3.2            Human information .............................................................................................................................. 15
    5.3.4       Summary and discussion of irritation ................................................................................ 15
5.4         Corrosivity .......................................................................................................................................................... 15
    5.4.1       Non-human information ..................................................................................................... 15
    5.4.2       Human information ............................................................................................................ 15
    5.4.3       Summary and discussion of corrosion ............................................................................... 15
5.5         Sensitisation ....................................................................................................................................................... 15
    5.5.1       Skin .................................................................................................................................... 15
      5.5.1.1            Non-human information ....................................................................................................................... 15
      5.5.1.2            Human information .............................................................................................................................. 15
    5.5.2       Respiratory system ............................................................................................................. 15
      5.5.2.1            Non-human information ....................................................................................................................... 15
      5.5.2.2            Human information .............................................................................................................................. 15
    5.5.3       Summary and discussion of sensitisation........................................................................... 16
5.6         Repeated dose toxicity........................................................................................................................................ 16
    5.6.1       Non-human information ..................................................................................................... 16
      5.6.1.1            Repeated dose toxicity: oral ................................................................................................................. 16
      5.6.1.2            Repeated dose toxicity: inhalation ....................................................................................................... 16
      5.6.1.3            Repeated dose toxicity: dermal ............................................................................................................ 16
      5.6.1.4            Repeated dose toxicity: other routes .................................................................................................... 16
    5.6.2       Human information ............................................................................................................ 16
    5.6.3       Summary and discussion of repeated dose toxicity ........................................................... 16
5.7         Mutagenicity....................................................................................................................................................... 16



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                                                                                               CHEMICAL SAFETY REPORT TEMPLATE

    5.7.1       Non-human information ..................................................................................................... 16
       5.7.1.1           In vitro data .......................................................................................................................................... 16
       5.7.1.2           In vivo data........................................................................................................................................... 16
    5.7.2       Human information ............................................................................................................ 16
    5.7.3       Summary and discussion of mutagenicity ......................................................................... 16
5.8         Carcinogenicity .................................................................................................................................................. 16
    5.8.1       Non-human information ..................................................................................................... 16
       5.8.1.1           Carcinogenicity: oral ............................................................................................................................ 16
       5.8.1.2           Carcinogenicity: inhalation .................................................................................................................. 16
       5.8.1.3           Carcinogenicity: dermal ....................................................................................................................... 16
    5.8.2       Human information ............................................................................................................ 16
    5.8.3       Summary and discussion of carcinogenicity ...................................................................... 16
5.9         Toxicity for reproduction ................................................................................................................................... 17
    5.9.1       Effects on fertility .............................................................................................................. 17
       5.9.1.1           Non-human information ....................................................................................................................... 17
       5.9.1.2           Human information .............................................................................................................................. 17
    5.9.2       Developmental toxicity ...................................................................................................... 17
       5.9.2.1           Non-human information ....................................................................................................................... 17
       5.9.2.2           Human information .............................................................................................................................. 17
    5.9.3       Summary and discussion of reproductive toxicity ............................................................. 17
5.10        Other effects ....................................................................................................................................................... 17
    5.10.1           Non-human information ................................................................................................. 17
       5.10.1.1          Neurotoxicity ....................................................................................................................................... 17
       5.10.1.2          Immunotoxicity .................................................................................................................................... 17
       5.10.1.3          Specific investigations: other studies ................................................................................................... 17
    5.10.2           Human information ........................................................................................................ 17
    5.10.3           Summary and discussion ................................................................................................ 17
5.11        Derivation of DNEL(s) /DMELs ........................................................................................................................ 17
    5.11.1    Overview of typical dose descriptors for all endpoints.................................................. 17
    5.11.2    Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative
    descriptor for critical health effects ............................................................................................... 19
6      HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES ............. 20
6.1         Explosivity ......................................................................................................................................................... 20
6.2         Flammability ...................................................................................................................................................... 20
6.3         Oxidising potential ............................................................................................................................................. 20
7      ENVIRONMENTAL HAZARD ASSESSMENT ........................................................................ 21
7.1         Aquatic compartment (including sediment) ....................................................................................................... 21
    7.1.1       Toxicity data ...................................................................................................................... 21
       7.1.1.1     Fish ....................................................................................................................................................... 21
          7.1.1.1.1 Short-term toxicity to fish ............................................................................................................... 21
          7.1.1.1.2 Long-term toxicity to fish ................................................................................................................ 21
       7.1.1.2     Aquatic invertebrates ........................................................................................................................... 21
          7.1.1.2.1 Short-term toxicity to aquatic invertebrates .................................................................................... 21
          7.1.1.2.2 Long-term toxicity to aquatic invertebrates ..................................................................................... 21



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CHEMICAL SAFETY REPORT TEMPLATE

       7.1.1.3           Algae and aquatic plants ...................................................................................................................... 21
       7.1.1.4           Sediment organisms ............................................................................................................................. 21
       7.1.1.5           Other aquatic organisms ....................................................................................................................... 21
    7.1.2       Calculation of Predicted No Effect Concentration (PNEC)............................................... 21
       7.1.2.1           PNEC water.......................................................................................................................................... 21
       7.1.2.2           PNEC sediment .................................................................................................................................... 22
7.2         Terrestrial compartment ..................................................................................................................................... 22
    7.2.1       Toxicity data ...................................................................................................................... 22
       7.2.1.1           Toxicity to soil macro organisms ......................................................................................................... 22
       7.2.1.2           Toxicity to terrestrial plants ................................................................................................................. 22
       7.2.1.3           Toxicity to soil micro-organisms ......................................................................................................... 22
       7.2.1.4           Toxicity to other terrestrial organisms ................................................................................................. 22
    7.2.2       Calculation of Predicted No Effect Concentration (PNEC_soil) ....................................... 22
7.3         Atmospheric compartment ................................................................................................................................. 22
7.4         Microbiological activity in sewage treatment systems ....................................................................................... 22
    7.4.1       Toxicity to aquatic micro-organisms ................................................................................. 22
    7.4.2       PNEC for sewage treatment plant ...................................................................................... 22
7.5         Non compartment specific effects relevant for the food chain (secondary poisoning) ...................................... 23
    7.5.1       Toxicity to birds ................................................................................................................. 23
    7.5.2       Toxicity to mammals ......................................................................................................... 23
    7.5.3       Calculation of PNECoral (secondary poisoning) ............................................................... 23
7.6         Conclusion on the environmental classification and labelling ........................................................................... 23
8      PBT AND VPVB ASSESSMENT ............................................................................................. 24
8.1         Assessment of PBT/vPvB Properties ................................................................................................................. 24
    8.1.1       Summary and overall conclusions on PBT or vPvB properties ......................................... 24
    8.1.2       Assessed substance: Substance itself ................................................................................. 24
8.2         Emission characterisation ................................................................................................................................... 27
9      EXPOSURE ASSESSMENT .................................................................................................... 28
9.0         General information ........................................................................................................................................... 28
    9.0.1       Overview ............................................................................................................................ 28
       9.0.1.1           Overview of exposure scenarios .......................................................................................................... 28
       9.0.1.2           Overview of uses .................................................................................................................................. 28
    9.0.2       Scope and type of exposure assessment ............................................................................. 29
       9.0.2.1           Environment ......................................................................................................................................... 29
       9.0.2.2           Worker ................................................................................................................................................. 31
       9.0.2.3           Consumer ............................................................................................................................................. 32
    9.0.3       Regional environmental exposure from the releases of all exposure scenarios covered ... 32
       9.0.3.1           Total releases........................................................................................................................................ 32
       9.0.3.2           Regional exposure: environment .......................................................................................................... 33
       9.0.3.3           Regional exposure: man via environment ............................................................................................ 33
9.x <NAME OF EXPOSURE SCENARIO X> ................................................................................................................ 34
    9.x.1 Exposure scenario ................................................................................................................. 34
       9.x.1.1. Control of environmental exposure: <contributing scenario name> .......................................................... 34
       9.x.1.2. Control of workers exposure for "<Contributing scenario name>" [<PROC>] ......................................... 34


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                                                                                             CHEMICAL SAFETY REPORT TEMPLATE

        9.x.1.2. Control of consumers exposure for "<Contributing scenario name>" ....................................................... 35
        9.x.2.1 Exposure estimation for the environment (<contributing scenario name>) ................................................ 36
           9.x.2.1.1 Environmental releases ..................................................................................................................... 36
           9.x.2.1.2 Environmental exposure ................................................................................................................... 36
           9.x.2.1.3 Indirect exposure of humans via the environment ......................................................................... 37
        9.x.2.2 Exposure estimation for workers / consumers for ....................................................................................... 38
10           RISK CHARACTERISATION ............................................................................................. 39
10.x (Title of exposure scenario x) ................................................................................................................................... 39
     10.x.1 Human Health ..................................................................................................................... 39
        10.x.1.1 Workers ..................................................................................................................................................... 39
        10.x.1.2 Consumers ................................................................................................................................................. 40
        10.x.1.3 Indirect exposure of humans via the environment ..................................................................................... 40
     10.x.2 Environment ........................................................................................................................ 41
        10.x.2.0 Risk characterisation for PBT ................................................................................................................... 41
        10.x.2.1 Aquatic compartment (incl. sediment) ...................................................................................................... 41
        10.x.2.2 Terrestrial compartment ............................................................................................................................ 42
        10.x.2.3 Atmospheric compartment ........................................................................................................................ 42
        10.x.2.4 Microbiological activity in sewage treatment systems .............................................................................. 42
10.n Overall exposure (combined for all relevant emission/release sources) ................................................................... 42
     10.n.1 Human health (combined for all exposure routes) .............................................................. 42
     10.n.2 Environment (combined for all emission sources) ............................................................. 43
        10.n.2.1 Exposure and risks due to all wide dispersive uses ................................................................................... 43
REFERENCES ............................................................................................................................... 44




                                                                            TABLES
TABLE 1:   SUBSTANCE IDENTITY .................................................................................................................................. 8
TABLE 2:   CONSTITUENTS ............................................................................................................................................ 8
TABLE 3:   IMPURITIES .................................................................................................................................................. 8
TABLE 4:   ADDITIVES ................................................................................................................................................... 8
TABLE 5:   OVERVIEW OF PHYSICOCHEMICAL PROPERTIES ........................................................................................... 9
TABLE 6:   DESCRIPTION OF IDENTIFIED USES ............................................................................................................. 10
TABLE 7:   CLASSIFICATION ACCORDING TO DIRECTIVE 67/548/EEC CRITERIA ......................................................... 11
TABLE 8:   EXAMPLE TABLE FOR REPORTING (ROBUST) STUDY SUMMARIES ............................................................... 12
TABLE 9:   EXAMPLE TABLE FOR REPORTING (ROBUST) STUDY SUMMARIES ............................................................... 14
TABLE 10:  AVAILABLE DOSE DESCRIPTOR(S) PER ENDPOINT FOR A CERTAIN SUBSTANCE AS A RESULT OF ITS HAZARD
    ASSESSMENT. ........................................................................................................................................................... 18
TABLE 11:  DN(M)ELS FOR WORKERS ........................................................................................................................ 19
TABLE 12:  DN(M)ELS FOR THE GENERAL POPULATION ............................................................................................. 19
TABLE 13:  EXAMPLE TABLE FOR REPORTING (ROBUST) STUDY SUMMARIES ............................................................... 20
TABLE 14:  EXAMPLE TABLE FOR REPORTING (ROBUST) STUDY SUMMARIES ............................................................... 21
TABLE 15:  PNEC AQUATIC ......................................................................................................................................... 21
TABLE 16:  PNEC SEDIMENT ....................................................................................................................................... 22
TABLE 17:  PNEC SOIL ................................................................................................................................................ 22
TABLE 18:  PNEC SEWAGE TREATMENT PLANT ........................................................................................................... 22
TABLE 19:  PNEC ORAL............................................................................................................................................... 23
TABLE 20:  OVERVIEW OF EXPOSURE SCENARIOS (ES) DESCRIBED IN SECTIONS 9.1FF. ............................................... 28
TABLE 21:  OVERVIEW OF USES BROKEN DOWN BY LIFE CYCLE STAGES AND THE EXPOSURE SCENARIOS (ES)
    DESCRIBED IN SECTIONS 9.1FF. ................................................................................................................................ 28




                                                                                                                                                                               5
CHEMICAL SAFETY REPORT TEMPLATE

TABLE 22:   TABLE: SCOPE AND TYPE OF EXPOSURE ASSESSMENT BASED ON HAZARD ASSESSMENT ............................ 30
TABLE 23:   SCOPE AND TYPE OF EXPOSURE ASSESSMENT BASED ON HAZARD ASSESSMENT ......................................... 31
TABLE 24:   SCOPE AND TYPE OF EXPOSURE ASSESSMENT BASED ON HAZARD ASSESSMENT ......................................... 32
TABLE 25:   SUMMARY OF PREDICTED REGIONAL EXPOSURE CONCENTRATIONS (REGIONAL PEC) .............................. 33
TABLE 26:   SUMMARY OF ESTIMATED DAILY HUMAN DOSES THROUGH INTAKE AND CONCENTRATIONS IN FOOD FROM
    REGIONAL EXPOSURE ............................................................................................................................................... 33
TABLE 27:   SUMMARY OF THE LOCAL RELEASES TO THE ENVIRONMENT ...................................................................... 36
TABLE 28:   SUMMARY OF EXPOSURE CONCENTRATIONS .............................................................................................. 37
TABLE 29:   SUMMARY OF ESTIMATED DAILY HUMAN DOSES THROUGH INTAKE AND CONCENTRATIONS IN FOOD ........ 38
TABLE 30:   SUMMARY OF EXPOSURE CONCENTRATION FOR CONTRIBUTING SCENARIO: .............................................. 38
TABLE 31:   RISK CHARACTERISATION: <CONTRIBUTING SCENARIO NAME> ................................................................ 39
TABLE 32:   RISK CHARACTERISATION: <CONTRIBUTING SCENARIO NAME> ................................................................ 40
TABLE 33:   RISK CHARACTERISATION FOR HUMANS EXPOSED VIA THE ENVIRONMENT ................................................ 41
TABLE 34:   CLOCAL/PNEC RATIOS.............................................................................................................................. 41
TABLE 35:   RISK CHARACTERISATION FOR THE AQUATIC COMPARTMENT (INCL. SEDIMENT AND SECONDARY
    POISONING) .............................................................................................................................................................. 41
TABLE 36:   RISK CHARACTERISATION FOR THE TERRESTRIAL COMPARTMENT (INCL. SECONDARY POISONING) ........... 42
TABLE 37:   RISK CHARACTERISATION FOR THE MICROBIOLOGICAL ACTIVITY IN SEWAGE TREATMENT SYSTEMS ........ 42
TABLE 38:   RISK CHARACTERISATION FOR THE EXPOSURE DUE TO ALL WIDE DISPERSIVE USES ................................... 43



                                                                           FIGURES




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                              CHEMICAL SAFETY REPORT TEMPLATE


                        PART A

1   SUMMARY OF RISK MANAGEMENT MEASURES

2   DECLARATION THAT RISK MANAGEMENT MEASURES ARE
    IMPLEMENTED

3   DECLARATION THAT RISK MANAGEMENT MEASURES ARE
    COMMUNICATED




                                                            7
CHEMICAL SAFETY REPORT TEMPLATE


                                                 PART B

1            IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL
             PROPERTIES

1.1          Name and other identifiers of the substance

Table 1:         Substance identity
EC number:

EC name:

CAS number (EC inventory):

CAS number:

CAS name:

IUPAC name:

Annex I index number

Molecular formula:

Molecular weight range:

Structural formula:



1.2          Composition of the substance

Table 2:         Constituents
Constituent                   Typical concentration      Concentration range        Remarks




Table 3:         Impurities
Impurities                    Typical concentration      Concentration range        Remarks




Table 4:         Additives
Constituent               Function         Typical concentration   Concentration range   Remarks




8
                                                          CHEMICAL SAFETY REPORT TEMPLATE

1.3           Physicochemical properties



Table 5:            Overview of physicochemical properties
Property                                        Results        Value used for CSA / Discussion
Physical state at 20°C and 101.3 kPa
Melting/freezing point
Boiling point
Relative density
Vapour pressure
Surface tension
Water solubility
Partition coefficient n-octanol/water (log
value)
Flash point
Flammability
Explosive properties
Self-ignition temperature
Oxidising properties
Granulometry
Stability in organic solvents and identity of
relevant degradation products
Dissociation constant
Viscosity
Reactivity towards container material
Thermal stability
[enter other property or delete row]




                                                                                                 9
CHEMICAL SAFETY REPORT TEMPLATE


2            MANUFACTURE AND USES

2.1          Manufacture

2.2          Identified uses

Table 6:          Description of identified uses
Identified    Sector of Use (SoU)      Preparation             Process category         Article category
use                                    Category (PC)           (PROC)                   (AC)




2.3          Uses advised against

3            CLASSIFICATION AND LABELLING1

3.1          Classification and labelling in Annex I of Directive 67/548/EEC
Classification
[The substance] is classified [if applicable]:
         for physical - chemical properties:
         for health effects:
         for the environment:
Labelling
Indication of danger:
R-phrases:
S-phrases:
Specific concentration limits:




1The template will be updated once the Regulation on Classification, Labelling and Packaging of substances and
mixtures (implementing the GHS) will be adopted.



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                                                               CHEMICAL SAFETY REPORT TEMPLATE

3.2         Self classification(s) and labelling

Table 7:            Classification according to Directive 67/548/EEC criteria
Endpoints                                     Classification            Reason for no    Justification
                                                                        classification   for (non)
                                                                                         classification
                                                                                         can be found
                                                                                         in section
Explosiveness                                                                            6.1
Oxidising properties                                                                     6.3
Flammability                                                                             6.2
Thermal stability
Acute toxicity                                                                           5.2
Acute toxicity- irreversible damage after                                                5.2
single exposure
Repeated dose toxicity                                                                   5.6
Irritation / Corrosion                                                                   5.3.4 and 5.4.3
Sensitisation                                                                            5.5.3
Carcinogenicity                                                                          5.8.3
Mutagenicity - Genetic Toxicity                                                          5.7.3
Toxicity to reproduction- fertility                                                      5.9.3
Toxicity to reproduction- development                                                    5.9.3
Toxicity to reproduction – breastfed babies                                              5.9.3
Environment                                                                              7.6


Labelling
Indication of danger:
R-phrases:
S-phrases:
Specific concentration limits:




                                                                                                           11
CHEMICAL SAFETY REPORT TEMPLATE


4          ENVIRONMENTAL FATE PROPERTIES
Whenever results from (robust) study summaries are reported in any sections the following table
could be used.

Table 8:       Example table for reporting (robust) study summaries
Method                        Results                    Remarks           Reference




4.1        Degradation

4.1.1      Abiotic degradation

4.1.1.1    Hydrolysis

4.1.1.2    Phototransformation/photolysis

4.1.1.2.1 Phototransformation in air

4.1.1.2.2 Phototransformation in water

4.1.1.2.3 Phototransformation in soil

4.1.2      Biodegradation

4.1.2.1    Biodegradation in water

4.1.2.1.1 Estimated data

4.1.2.1.2 Screening tests

4.1.2.1.3 Simulation tests

4.1.2.2    Biodegradation in sediments

4.1.2.3    Biodegradation in soil

4.1.2.4    Summary and discussion on biodegradation

4.1.3      Summary and discussion on degradation




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                                              CHEMICAL SAFETY REPORT TEMPLATE

4.2     Environmental distribution

4.2.1    Adsorption/desorption

4.2.2    Volatilisation

4.2.3    Distribution modelling

4.3      Bioaccumulation

4.3.1    Aquatic bioaccumulation

4.3.2    Terrestrial bioaccumulation

4.3.3    Summary and discussion of bioaccumulation

4.4      Secondary poisoning




                                                                           13
CHEMICAL SAFETY REPORT TEMPLATE


5          HUMAN HEALTH HAZARD ASSESSMENT
Whenever results from (robust) study summaries are reported in any sections the following table
could be used.

Table 9:       Example table for reporting (robust) study summaries
Method                            Results                 Remarks            Reference




5.1        Toxicokinetics (absorption, metabolism, distribution and elimination)

5.1.1      Non-human information

5.1.2      Human information

5.1.3      Summary and discussion on toxicokinetics

5.2        Acute toxicity

5.2.1      Non-human information

5.2.1.1    Acute toxicity: oral

5.2.1.2    Acute toxicity: inhalation

5.2.1.3    Acute toxicity: dermal

5.2.1.4    Acute toxicity: other routes

5.2.2      Human information

5.2.3      Summary and discussion of acute toxicity




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                                                 CHEMICAL SAFETY REPORT TEMPLATE

5.3       Irritation

5.3.1     Skin

5.3.1.1   Non-human information

5.3.1.2   Human information

5.3.2     Eye

5.3.2.1   Non-human information

5.3.2.2   Human information

5.3.3     Respiratory tract

5.3.3.1   Non-human information

5.3.3.2   Human information

5.3.4     Summary and discussion of irritation

5.4       Corrosivity

5.4.1     Non-human information

5.4.2     Human information

5.4.3     Summary and discussion of corrosion

5.5       Sensitisation

5.5.1     Skin

5.5.1.1   Non-human information

5.5.1.2   Human information

5.5.2     Respiratory system

5.5.2.1   Non-human information

5.5.2.2   Human information



                                                                              15
CHEMICAL SAFETY REPORT TEMPLATE

5.5.3     Summary and discussion of sensitisation

5.6       Repeated dose toxicity

5.6.1     Non-human information

5.6.1.1   Repeated dose toxicity: oral

5.6.1.2   Repeated dose toxicity: inhalation

5.6.1.3   Repeated dose toxicity: dermal

5.6.1.4   Repeated dose toxicity: other routes

5.6.2     Human information

5.6.3     Summary and discussion of repeated dose toxicity

5.7       Mutagenicity

5.7.1     Non-human information

5.7.1.1   In vitro data

5.7.1.2   In vivo data

5.7.2     Human information

5.7.3     Summary and discussion of mutagenicity

5.8       Carcinogenicity

5.8.1     Non-human information

5.8.1.1   Carcinogenicity: oral

5.8.1.2   Carcinogenicity: inhalation

5.8.1.3   Carcinogenicity: dermal

5.8.2     Human information

5.8.3     Summary and discussion of carcinogenicity



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                                                            CHEMICAL SAFETY REPORT TEMPLATE

5.9        Toxicity for reproduction

5.9.1      Effects on fertility

5.9.1.1    Non-human information

5.9.1.2    Human information

5.9.2      Developmental toxicity

5.9.2.1    Non-human information

5.9.2.2    Human information

5.9.3      Summary and discussion of reproductive toxicity

5.10       Other effects

5.10.1     Non-human information

5.10.1.1 Neurotoxicity

5.10.1.2 Immunotoxicity

5.10.1.3 Specific investigations: other studies

5.10.2     Human information

5.10.3    Summary and discussion

5.11       Derivation of DNEL(s) /DMELs2

5.11.1     Overview of typical dose descriptors for all endpoints




2 The heading has been slightly modified compared to the format given in Annex I of the REACH Regulation (section
7) to clarify the content of the section.



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Table 10:      Available dose descriptor(s) per endpoint for a certain substance as a result of
its hazard assessment.
Endpoint                                               Quantitative dose                       Associated                 Remarks on study5
                                                       descriptor3 (appropriate                relevant effect4
                                                       unit) or qualitative
                                                       assessment
                                                       Local6            Systemic7
Acute toxicity8                 oral
                                dermal
                                inhalation
Irritation/Corrosivity          skin                                     NA9
                                eye                                      NA
                                resp. tract                              NA
Sensitisation                   skin                                     NA
                                resp. tract                              NA
Repeated dose toxicity          oral
sub-acute/ sub-chronic/         dermal
chronic
                                inhalation
Mutagenicity                    in vitro
                                in vivo
Carcinogenicity                 oral
                                dermal
                                inhalation
Reproductive                    oral                   NA
toxicity10
                                dermal                 NA
fertility impairment
                                inhalation             NA
Reproductive toxicity           oral                   NA
developmental tox               dermal                 NA
                                inhalation             NA




3 NOAEL (NOAEC), LOAEL , T25, BMD(L)10 or any other dose descriptor; indicate whether this concerns a no or lowest observed effect level etc
4 In this column the relevant effect for which the dose descriptor is determined is provided
5 This column is for indicating whether data were available, whether the substance is classified for this endpoint, for shortly describing specifics of
the study (e.g. 28-d gavage rat, 5 d/wk or 2-gen diet rat, 7 d/wk), and for indicating (additional) uncertainty in available data
6 Local exposure: units are mg/m3 for inhalation, and mg/cm2 or ppm for dermal exposure
7 Systemic: units are mg/m3 for inhalation, and mg/kg bw/day for oral and dermal exposure
8 In general, sublethal toxicity is a more rational starting point for acute toxicity than mortality data; information on acute toxicity may also be
derived from e.g. repeated dose toxicity studies or reproductive toxicity studies
9 Not Applicable
10 These repeated exposure studies may also show relevant acute effects of the test substance; these should be accounted for under the endpoint acute
toxicity



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5.11.2       Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative
             descriptor for critical health effects

Table 11:          DN(M)ELs for workers11
Exposure pattern            Route                 Descriptors12    DNEL/DMEL            Most             Justification
                                                                   (appropriate         sensitive
                                                                   unit)                endpoint
Acute - systemic effects    dermal (mg/kg bw
                            /day)
                            Inhalation (mg/m3)
Acute - local effects       Dermal (mg/cm2)
                            Inhalation (mg/m3)
Long-term - systemic        Dermal (mg/kg bw
effects                     /day)
                            Inhalation (mg/m3)
Long-term – local           Dermal (mg/cm2)
effects
                            Inhalation (mg/m3)




Discussion



Table 12:          DN(M)ELs for the general population13
Exposure pattern        Route                     Descriptors      DNEL/DMEL             Most            Justification
                                                                   (appropriate          sensitive
                                                                   unit)                 endpoint
Acute - systemic        Dermal (mg/kg bw
effects                 /day)
                        Inhalation (mg/m3)
                        Oral (mg/kg bw /day)
Acute - local           Dermal (mg/cm2)
effects
                        Inhalation (mg/m3)



11 As the respiration rate is taken into account for the derivation of the DNEL, this table need to be repeated in case
different exposure scenarios lead to different respiration rate.
12 Values   in IUCLID 5 are DNEL/DMEL/ not quantifiable
13 General population includes consumers and humans via the environment. In rare cases it may also be relevant to
derive a DNEL for specific subpopulations, such as children. In this case the table need to be repeated. In addition as
the respiration rate is taken into account for the derivation of the DNEL, this table need to be repeated in case different
exposure scenarios lead to different respiration rate.




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Long-term -           dermal(mg/kg bw /day)
systemic effects
                      Inhalation (mg/m3)
                      oral(mg/kg bw /day)
Long-term – local     Dermal (mg/cm2)
effects
                      Inhalation (mg/m3)



Discussion

6          HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL
           PROPERTIES
Whenever results from (robust) study summaries are reported in any sections the following table
could be used.

Table 13:          Example table for reporting (robust) study summaries
Method                               Results                Remarks          Reference




6.1        Explosivity

6.2        Flammability

6.3        Oxidising potential




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7          ENVIRONMENTAL HAZARD ASSESSMENT
Whenever results from (robust) study summaries are reported in any sections the following table
could be used.

Table 14:         Example table for reporting (robust) study summaries
Method                              Results                  Remarks             Reference




7.1        Aquatic compartment (including sediment)

7.1.1      Toxicity data

7.1.1.1    Fish

7.1.1.1.1 Short-term toxicity to fish

7.1.1.1.2 Long-term toxicity to fish

7.1.1.2    Aquatic invertebrates

7.1.1.2.1 Short-term toxicity to aquatic invertebrates

7.1.1.2.2 Long-term toxicity to aquatic invertebrates

7.1.1.3    Algae and aquatic plants

7.1.1.4    Sediment organisms

7.1.1.5    Other aquatic organisms

7.1.2      Calculation of Predicted No Effect Concentration (PNEC)

7.1.2.1    PNEC water

Table 15:         PNEC aquatic
                                       Value    Assessment    Remarks/Justification
                                                factor
PNEC aqua – freshwater (mg/l)
PNEC aqua - marine water (mg/l)
PNEC aqua – intermittent releases
(mg/l)




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7.1.2.2    PNEC sediment

Table 16:           PNEC sediment
                                    Value         Assessment factor   Remarks/Justification
PNEC sediment ( mg/kg d.w.)


7.2        Terrestrial compartment

7.2.1      Toxicity data

7.2.1.1    Toxicity to soil macro organisms

7.2.1.2    Toxicity to terrestrial plants

7.2.1.3    Toxicity to soil micro-organisms

7.2.1.4    Toxicity to other terrestrial organisms

7.2.2      Calculation of Predicted No Effect Concentration (PNEC_soil)

Table 17:           PNEC soil
                                    Value         Assessment factor   Remarks/Justification
PNEC soil ( mg/kg.w.)


7.3        Atmospheric compartment

7.4        Microbiological activity in sewage treatment systems

7.4.1      Toxicity to aquatic micro-organisms

7.4.2      PNEC for sewage treatment plant

Table 18:           PNEC sewage treatment plant
                                    Value         Assessment factor   Remarks/Justification
PNEC stp ( mg/l.)




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7.5         Non compartment specific effects relevant for the food
            chain (secondary poisoning) 14

7.5.1       Toxicity to birds

7.5.2       Toxicity to mammals

7.5.3       Calculation of PNECoral (secondary poisoning)

Table 19:         PNEC oral
                                          Value            Assessment factor        Remarks/Justification
PNEC oral ( mg/kg food)




7.6         Conclusion on the environmental classification and labelling15




14  The effects via food chain accumulation have to be evaluated (see Annex I of REACH Regulation, section 3.0.2) and
it is suggested to report the effect assessment relevant for that purpose under this heading, although it does not exist in
the format given in Annex I of REACH Regulation, section 7.
15 The classification and labelling has to be presented and justified (see Annex I REACH Regulation, section 1.3.). For
the environment it is suggested to report that assessment under this heading, although it does not exist in the format
given in Annex I of REACH Regulation, section 7.



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8           PBT AND VPVB ASSESSMENT

8.1         Assessment of PBT/vPvB Properties16

     8.1.1 Summary and overall conclusions on PBT or vPvB properties
Overall conclusion: Based on the assessment described in the subsections below the submission
substance is not considered as PBT / vPvB.
Overall conclusion: Based on the assessment described in the subsections below the submission
substance is considered as PBT / vPvB or treated as if it were a PBT / vPvB substance.
Rationale
PBT/vPvB criteria and justification

     8.1.2 Assessed substance: Substance itself
8.1.2.1 Assessed substance: Constituent: <Constituent>
8.1.2.2 Assessed substance: Transformation product: <Transformation product>


Persistence assessment
Screening criteria



Screening test                  Test results / Justification
Ready biodegradability
test(s)
Inherent biodegradability
test(s) under valid
conditions


The assessed substance is readily biodegradable indicating that the substance is not a P/vP.

The assessed substance is inherently biodegradable indicating that the substance is not a P.

The available data from screening tests do not allow concluding that the assessed substance is not a
P / vP.

There are no appropriate data available from screening tests for drawing conclusions as to the P / vP
properties of the assessed substance.



16   Please remove all predefined texts and/or table(s) if not relevant and/or appropriate.



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                                                             CHEMICAL SAFETY REPORT TEMPLATE

Criteria based on Annex XIII of REACH



Criterion for non-P           Test results / Justification
T1/2 <= 60 days in marine
water
T1/2 <= 40 days in fresh-
or estuarine water
T1/2 <= 180 days in
marine sediment
T1/2 <= 120 days in fresh-
or estuarine sediment
T1/2 <= 120 days in soil


Criterion for non-vP
T1/2 <= 60 days in
marine, fresh- or estuarine
water
T1/2 <= 180 days in
marine, fresh- or estuarine
sediment
T1/2 <= 180 days in soil


Based on the available half-life data it cannot be concluded that the assessed substance is not a P /
vP.
The available half-life data indicate that the assessed substance is not a P.
The available half-life data indicate that the assessed substance is not a vP.
There are no appropriate half-life data available for drawing conclusions as to the P / vP properties
of the assessed substance.

Other evidence of non-P / non-vP
There is other evidence available allowing the conclusion that the assessed substance is not a P / vP.
Testing proposal
A testing proposal has been submitted.
Conclusion of P / vP assessment
Bioaccumulation assessment


Screening criteria




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CHEMICAL SAFETY REPORT TEMPLATE


Screening test                Test results / Justification
Log Kow <= 4.5


The Log Kow for the assessed substance is <= 4.5 indicating that the substance is not a B/vB.
Criteria based on Annex XIII of REACH

Criterion for non-B                 Test results / Justification
BCF <= 2000 L/kg


Criterion for non-vB                Test results / Justification
BCF <= 5000 L/kg
Based on the available BCF data it cannot be concluded that the assessed substance is not a B / vB.
The available BCF data indicate that the assessed substance is not a B.
The available BCF data indicate that the assessed substance is not a vB.
Other evidence of non-B / non-vB
There is other evidence available allowing the conclusion that the assessed substance is not a B /
vB.
Testing proposal
A testing proposal has been submitted.
Conclusion of B / vB assessment
Toxicity assessment
Criteria based on Annex XIII of REACH

Criterion for non-T                 Test results / Justification
NOEC >= 0.01 mg/L for marine
or freshwater organisms (long-
term toxicity)
Substance is not classified as
carcinogenic (category 1 or 2),
mutagenic (category 1 or 2), or
toxic for reproduction (category
1, 2 or 3)
No other evidence of chronic
toxicity, as identified by the
classifications: T, R48, or Xn,
R48 according to Directive
67/548/EEC


Based on the available information it cannot be concluded that the assessed substance is not a T.


The available information indicates that the assessed substance is not a T.

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                                                      CHEMICAL SAFETY REPORT TEMPLATE

Other evidence of non-T
There is other evidence available allowing the conclusion that the assessed substance is not a T.
Testing proposal
A testing proposal has been submitted.
Conclusion of T assessment

8.2     Emission characterisation
Operational conditions and risk management measures:
The operational conditions and risk management measures put in place are reported in the exposure
scenarios in sections "9.x.1.1. Control of environmental exposure".
Residual releases
The emissions values are reported in the sections "9.x.2.1.1 Environmental releases".
The sum of the release from all life cycle stages (across all exposure scenarios) is reported in
section "9.0.3.1 Total releases".
Likely routes by which humans and the environment are exposed:
Justification of minimisation of emission/exposure:
The justification of the minimisation of emissions and (subsequent) exposures of humans and the
environment is reported in sections "10.x.2.0 Risk characterisation for PBT".




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9            EXPOSURE ASSESSMENT17
The submission substance does not meet the criteria to be classified dangerous for physical,
environmental and health hazards nor is regarded as PBT or vPvB. Hence, according to Article
14(4) of the REACH regulation an exposure assessment and risk characterisation is not required.

9.0         General information

     9.0.1 Overview

     9.0.1.1       Overview of exposure scenarios

Table 20:           Overview of exposure scenarios (ES) described in sections 9.1ff.
ES     Exposure scenario                     Manufacture / Use / Subsequent service life      Stage no.*)
number name



*) Consecutive numbers of each stage; no unique ID numbers.


The stage numbers are set with the following rules: an abbreviation of the main life cycle stage
followed by consecutive numbers.
Manufacture: M-#, Formulation: F-#, Industrial end use: IW-#, Professional end use: PW-#,
Consumer end use: C-#, Service life (by workers in industrial settings): SL-IW-#, Service life (by
professional workers): SL-PW-#, Service life (by consumers): SL-C-#.



     9.0.1.2       Overview of uses

Table 21:    Overview of uses broken down by life cycle stages and the exposure scenarios
(ES) described in sections 9.1ff.




17   Please remove all predefined texts and/or table(s) if not relevant and/or appropriate.



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                                                               CHEMICAL SAFETY REPORT TEMPLATE


Main life          Stage       Manufacture / Use /              Related          Market        Tonnage ES
cycle stage        No.18       Subsequent service life          Subsequent       sector        (tonnes No.
                                                                service life                   per
                                                                                               year)




  9.0.2 Scope and type of exposure assessment



  9.0.2.1       Environment
The submission substance is considered as PBT / vPvB (see CSR section 8). Hence, a PBT
assessment has been carried out demonstrating minimisation of releases.
The submission substance is considered as PBT / vPvB (see CSR section 8). Hence, a PBT
assessment has been carried out. >>>NOTE: As appropriate, fill in the field "Justification of
minimisation of emission/exposure" and select the checkbox "Risk controlled" in the tab
"Environment (PBT/vPvB): Risk characterisation".<<<




18The stage numbers are set with the following rules: an abbreviation of the main life cycle stage followed by
consecutive numbers.

Manufacture: M-#, Formulation: F-#, Industrial end use: IW-#, Professional end use: PW-#, Consumer end use: C-#,
Service life (by workers in industrial settings): SL-IW-#, Service life (by professional workers): SL-PW-#, Service life
(by consumers): SL-C-#.

In IUCLID section 3.5 the numbering of identified uses is an integer. As Formulation uses and Industrial end uses are
reported in the same table they are numbered starting at 1001 for Formulation and starting at 2001 for Industrial end
uses. In the CSR both numbering systems are reported.



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Table 22:     Table: Scope and type of exposure assessment based on hazard assessment
Protectio   Type of assessment            Explanation / Justification
n target
Water:      Exposure assessment and       Aquatic toxicity unlikely. See justification in section 7.1.2.
            risk characterisation not     No potential for bioaccumulation
            required                      No potential to cause toxic effects if accumulated via the
                                          food chain
                                          Justification:

            Quantitative                  Quantitative exposure assessment (EUSES 2.1) and risk
                                          characterisation



                                          No data available: testing technically not feasible
            Qualitative risk              No or insufficient data available at present
            characterisation with
                                          No emission to STP expected
            quantitative exposure
                                          No exposure of sediment expected
            assessment where applicable
                                          Risk characterisation cannot be carried out due to missing
                                          input information.




Air:        Quantitative exposure
            assessment


Soil:       Exposure assessment and       No PNEC oral because no potential for bioaccumulation
            risk characterisation not     No potential to cause toxic effects if accumulated via the
            required                      food chain
                                          Justification:

            Quantitative                  Quantitative exposure assessment (EUSES 2.1) and risk
                                          characterisation


            Qualitative risk              No data available: testing technically not feasible
            characterisation with         No or insufficient data available at present
            quantitative exposure         No exposure of soil expected
            assessment where applicable   Risk characterisation cannot be carried out due to missing
                                          input information.




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  9.0.2.2     Worker

Table 23:        Scope and type of exposure assessment based on hazard assessment
Route of     Type of assessment               Explanation / Justification
exposure
and type
of effects
             Exposure assessment and risk     The substance does not meet the criteria to be classified
             characterisation not required    dangerous for respiratory irritation/corrosion and
                                              respiratory sensitisation.

                                              The substance does not meet the criteria to be classified
                                              dangerous for skin/eye irritation/corrosion and skin
                                              sensitisation.
                                              The substance does not meet the criteria to be classified
                                              dangerous for acute toxicity.



                                              Quantitative exposure assessment and risk
             Quantitative
                                              characterisation. See DNEL in section 5.11.2.



                                              Semi-quantitative exposure assessment and risk
                                              characterisation. See DMEL in section 5.11.2.
             Semi-quantitative




             Qualitative risk                 No data available: testing technically not feasible
             characterisation with            Insufficient data available: testing proposed
             quantitative exposure            No-threshold effect and/or no dose-response information
             assessment where applicable      available
                                              Exposure based waiving
                                              Risk characterisation cannot be carried out due to missing
                                              input information.




Hazard level (for qualitative assessment)
The hazard level is assigned based on the classification of the substance. The assignment rules are
described in section E.3.4.4 of part E of the Guidance on Information Requirement and Chemical
Safety Assessment. The hazard level determines the risk management strategy to be described in
the exposure scenarios.
Hazard level:
Justification:




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     9.0.2.3    Consumer

Table 24:          Scope and type of exposure assessment based on hazard assessment
Route of       Type of assessment              Explanation / Justification
exposure
and type
of effects
               Exposure assessment and risk    The substance does not meet the criteria to be classified
               characterisation not required   dangerous for respiratory irritation/corrosion and
                                               respiratory sensitisation.
                                               The substance does not meet the criteria to be classified
                                               dangerous for skin/eye irritation/corrosion and skin
                                               sensitisation.
                                               The substance does not meet the criteria to be classified
                                               dangerous for acute toxicity.

               Quantitative                    Quantitative exposure assessment and risk
                                               characterisation. See DNEL in section 5.11.2.

                                               Semi-quantitative exposure assessment and risk
               Semi-quantitative               characterisation. See DMEL in section 5.11.2.




                                               No data available: testing technically not feasible
               Qualitative risk
                                               Insufficient data available: testing proposed
               characterisation with
                                               No-threshold effect and/or no dose-response information
               quantitative exposure           available
               assessment where applicable     Exposure based waiving
                                               Risk characterisation cannot be carried out due to missing
                                               input information.




Hazard level (for qualitative assessment)
The hazard level is assigned based on the classification of the substance. The assignment rules are
described in section E.3.4.4 of part E of the Guidance on Information Requirement and Chemical
Safety Assessment.
Hazard level:
Justification:

     9.0.3 Regional environmental exposure from the releases of all exposure scenarios covered

     9.0.3.1    Total releases
Summed releases from all life cycle stages:
         Water:         tonnes/year



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          Air:             tonnes/year
          Soil:            tonnes/year

  9.0.3.2          Regional exposure: environment
The substance is considered as PBT/vPvB. Consequently the regional concentration cannot be
estimated.

Table 25:           Summary of predicted regional exposure concentrations (Regional PEC)
Protection target             Regional PEC
Water:
Air:
Soil:



  9.0.3.3          Regional exposure: man via environment
The substance is considered as PBT. Consequently, exposure to man via environment cannot be
estimated with sufficient reliability.
Regional total estimated daily intake for humans:



Table 26:    Summary of estimated daily human doses through intake and concentrations in
food from regional exposure
Type of            Estimated daily human dose         Concentration in food from
food               through intake from regional       regional exposure
                   exposure
Drinking           <Dose, Drinking water, regional>   <Conc., Drinking water, regional>
water
Fish               <Dose, Fish, regional>             <Conc., Fish, regional>
Leaf crops         <Dose, Leaf crops, regional>       <Conc., Leaf crops, regional>
Root crops         <Dose, Root crops, regional>       <Conc., Root crops, regional>
Meat               <Dose, Meat, regional>             <Conc., Meat, regional>
Milk               <Dose, Milk, regional>             <Conc., Milk, regional>




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9.x <NAME OF EXPOSURE SCENARIO X>



M Market sector:
Sector of use:
Article categories:

Environment:

Worker/Consumer



 Subsequent service life exposure scenario(s): number and name of all exposure scenarios
 developed for the service life stages that are referred to at the “stage”, i.e. ES 2: “service
 life of coated furniture” [only relevant for end-use stages]
 Exposure scenario of the uses leading to the inclusion of the substance into the article:
 number and name of all exposure scenarios developed for the end use stages that have
 referred to the selected service life stage, i.e. ES 1: “coating of furniture” [Only relevant for
 service life stage]


     9.x.1 Exposure scenario

[Add any explanation on the activities and technical processes covered in the exposure
scenario] (Freetext)




     9.x.1.1. Control of environmental exposure: <contributing scenario name>

[further specification – Environment]

<Determinant category heading>

[further specification on the determinant value]




     9.x.1.2. Control of workers exposure for "<Contributing scenario name>" [<PROC>]



 Article categories [for service life (by workers)]:




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                                                             CHEMICAL SAFETY REPORT TEMPLATE


                                                                                       Inhal19        Derm

                                                                                       Loc       Sys Loc Sys

<Determinant category heading>

<Determinant name>                              <Determinant value(including                     A,
                                                unit)> <effectiveness>                           L




     9.x.1.2. Control of consumers exposure for "<Contributing scenario name>"

<further specifications (product)>[for consumer use]
<further specifications (article)> [for service life (by consumers)]



                                                                             Inhal20      Derm         Oral

                                                                             Loc Sys Loc Sys Loc Sys

<Determinant category heading>

                                                                                          A,L



[further specification on the determinant value]




19 The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which
the determinant has been used for exposure estimation are reported.
20The route of exposure (Inhalation, Dermal, Oral) and type of effect (Local, Systemic and Acute or Long term) for
which the determinant has been used for exposure estimation are reported.



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9.x.2 Exposure estimation for <Name of Exposure scenario 1>

     9.x.2.1 Exposure estimation for the environment (<contributing scenario name>)



     9.x.2.1.1 Environmental releases



Table 27:       Summary of the local releases to the environment
Compart       Release factor    Explanation / Justification
ment          estimation
              method
Water                           Initial release factor (%):
                                Release factor after on site risk management (%):
                                Local release rate (kg/day):
                                Justification of SPERC initial release factor:
                                Explanation / Justification:
Air                             Initial release factor (%):
                                Release factor after on site risk management (%):
                                Local release rate (kg/day):
                                Justification of SPERC initial release factor:
                                Explanation / Justification:
Soil                            Initial release factor (%):
                                Release factor after on site risk management (%):
                                Justification of SPERC initial release factor:
                                Explanation / Justification:


Summed releases from all life cycle stages: see section 9.0.3.

     9.x.2.1.2 Environmental exposure
The substance is considered as PBT/vPvB. Consequently the regional concentration cannot be
estimated. The local concentrations are displayed in the following table.




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Table 28:     Summary of exposure concentrations
Protectio   Exposure                  Explanation / Justification
n target    concentration
Water:      Local PEC:                Representativity and reliability:
            Local concentration:      Remark on exposure value:
            Concentration:            <Remark on exposure value>
            (not used for RC)         Conditions of use leading to the exposure:
Air:        as above                  as above
Soil:       as above                  as above


For regional PECs: see section 9.0.3.2.



  9.x.2.1.3 Indirect exposure of humans via the environment
The substance is considered as PBT. Consequently, exposure to man via environment cannot be
estimated with sufficient reliability.
Exposure via inhalation
The exposure concentrations in air are reported in the Table "Summary of exposure concentrations"
of the preceding section 9.x.2.1.2 "Environmental exposure".
Exposure via food consumption: Total daily intake for humans
The substance is considered as PBT. Consequently exposure via the oral route cannot be estimated
with sufficient reliability
Representativity and reliability:
Remark on exposure value:




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Table 29:       Summary of estimated daily human doses through intake and concentrations in
food
Type of         Daily human dose through intake                            Explanation / Justification
food
                Total estimated daily intake for humans:                   Representativity and reliability:
                Regional total estimated daily intake for
                humans:                                                    Remark on exposure value:
                Estimated daily dose    Concentration in food from local
                through intake from     exposure
                local exposure
Drinking
water
Fish
Leaf crops
Root crops
Meat
Milk
                Dose from regional exposure: see section 9.0.3.3



     9.x.2.2 Exposure estimation for workers / consumers for

Table 30:       Summary of exposure concentration for contributing scenario:
Route of      Exposure    Method / name of                 Explanation / Justification
exposure      concentrati exposure assessment
and type      on
of effects
              (not used       Method:                      Representativity and reliability:
              for RC)         Name:                        Remark on exposure value:
                                                           Conditions of use leading to the exposure:




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10          RISK CHARACTERISATION21
The submission substance does not meet the criteria to be classified dangerous for physical,
environmental and health hazards nor is regarded as PBT or vPvB. Hence, according to Article
14(4) of the REACH regulation an exposure assessment and risk characterisation is not required.


See section 9.0.2 "Scope and type of exposure assessment" as to whether a risk characterisation is
required for the different target groups and exposure pathways.



10.x (Title of exposure scenario x)

     10.x.1 Human Health

     10.x.1.1 Workers
This exposure scenario does not address workers.



Table 31:   Risk characterisation: <Contributing scenario name>
Route    of Risk    characterisation Risk characterisation
exposure    ratio
and type of
effects
Inhalation: RCR =                                       Prevention of release/exposure:
Long term,
Systemic    Exposure/DMEL =                             Expected residual exposure:
                    Qualitative                 risk Conclusion on risk characterisation:
                    characterisation
                    Summed RCR including
                    contribution of exposure
                    via the environment (see
                    section 9.x.1.3):
Dermal:    RCR =
Long term,
Systemic
Combined   RCR =
routes:
Long term, Summed RCR including
           contribution of exposure

21   Please remove all predefined texts and/or table(s) if not relevant and/or appropriate.



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Systemic        via the environment (see
                section 9.x.1.3):



     10.x.1.2 Consumers
This exposure scenario does not address consumers.



Table 32:   Risk characterisation: <Contributing scenario name>
Route    of Risk    characterisation Risk characterisation
exposure    ratio
and type of
effects
Inhalation: RCR =                             Prevention of release/exposure:
Long term,
Systemic    Exposure/DMEL =                   Expected residual exposure:
                Qualitative           risk Conclusion on risk characterisation:
                characterisation
                Summed RCR including
                contribution of exposure
                via the environment see
                section    9.x.1.3:    (for
                Inhalation: Long term,
                Systemic and oral long
                term systemic if available)
Oral: Long RCR =
term,
Systemic
Combined     RCR
routes: long
term,        Summed RCR including
systemic     contribution of exposure
             via the environment (see
             section 9.x.1.3):



     10.x.1.3 Indirect exposure of humans via the environment
The substance is considered as PBT. Consequently, exposure to man via environment cannot be
estimated with sufficient reliability. See section 10.x.2.0 for Risk characterisation for PBT.




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                                                                CHEMICAL SAFETY REPORT TEMPLATE

Table 33:   Risk characterisation for humans exposed via the environment22
Route of Risk                   Risk characterisation
exposure   characterisation
and type ratio
of effects
                  RCR =                         Conclusion on risk characterisation:




     10.x.2 Environment

     10.x.2.0 Risk characterisation for PBT
The substance is considered as PBT (see section 8).
Justification of minimisation of emission/exposure

Table 34:           Clocal/PNEC ratios
Protection target                                       Clocal/PNEC
Fresh Water                                             <Clocal/PNEC>
Marine Water                                            <Clocal/PNEC>
Agricultural Soil                                       <Clocal/PNEC>


Expected residual releases
The total releases are displayed in section 9.0.3.1.
Expected residual releases:

     10.x.2.1 Aquatic compartment (incl. sediment)
See section 10.x.2.0

Table 35:    Risk characterisation for the aquatic compartment (incl. sediment and
 secondary poisoning)
Protection Risk              Risk characterisation
target      characterisation
            ratio
<Protectio        RCR =                    Prevention of releases and exposure:
n target>*)
                  Qualitative risk Expected residual releases and exposure:
                  characterisation
                                   Conclusion on risk characterisation:


22   Qualitative assessment still to be added



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     10.x.2.2 Terrestrial compartment


See section 10.x.2.0

Table 36:    Risk characterisation for the terrestrial compartment (incl. secondary
 poisoning)
Protection Risk               Risk characterisation
target      characterisation
            ratio
               RCR =               Prevention of releases and exposure:
               Qualitative risk Expected residual releases and exposure:
               characterisation
                                Conclusion on risk characterisation:



     10.x.2.3 Atmospheric compartment
See section 10.x.2.0
Conclusion on risk characterisation:

     10.x.2.4 Microbiological activity in sewage treatment systems
See section 10.x.2.0

Table 37:       Risk characterisation for the microbiological activity in sewage treatment
 systems
Protection     Risk                Risk characterisation
target         characterisation
               ratio
Sewage         RCR =               Prevention of releases and exposure:
Treatment
Plant          Qualitative     risk Expected residual releases and exposure:
(Effluent)     characterisation
                                    Conclusion on risk characterisation:



10.n Overall exposure (combined for all relevant emission/release sources)



     10.n.1 Human health (combined for all exposure routes)




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                                                  CHEMICAL SAFETY REPORT TEMPLATE

>>>Note: When relevant select the combinations of exposure scenarios which could result in
simultaneous exposure of humans and report the outcome of the assessment here.<<<



  10.n.2 Environment (combined for all emission sources)

  10.n.2.1 Exposure and risks due to all wide dispersive uses



Table 38:    Risk characterisation for the exposure due to all wide dispersive uses
Protection      PEC local due to all Risk characterisation
target          wide dispersive uses
Water:                                  RCR=


Soil:                                   RCR=




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REFERENCES




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