Chemical Safety Report Format

CHEMICAL SAFETY REPORT TEMPLATE
CHEMICAL SAFETY REPORT
Substance Name:
EC Number:
CAS Number:
Registrant’s identity
1
CONTENTS
PART A
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
PART B
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 Physico-chemical 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
1
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

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

5.2.1.1 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
5.2.3 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
5.3.3 Respiratory tract...................................................................................................................................15
5.3.4 Summary and discussion of irritation...................................................................................................15
5.4 Corrosivity.......................................................................................................................................................15
5.4.3 Summary and discussion of corrosion..................................................................................................15
5.5 Sensitisation.....................................................................................................................................................15
5.5.1 Skin.......................................................................................................................................................15
5.5.2 Respiratory system...............................................................................................................................15
5.5.3 Summary and discussion of sensitisation.............................................................................................16
5.6 Repeated dose toxicity.....................................................................................................................................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
5.6.3 Summary and discussion of repeated dose toxicity:.............................................................................16
2
5.7 Mutagenicity....................................................................................................................................................16
5.7.1.1 In vitro data.............................................................................................................................16
5.7.1.2 In vivo data.............................................................................................................................16
5.7.3 Summary and discussion of mutagenicity............................................................................................16
5.8 Carcinogenicity................................................................................................................................................16
5.8.1.1 Carcinogenicity: oral..............................................................................................................16
5.8.1.2 Carcinogenicity: inhalation....................................................................................................16
5.8.1.3 Carcinogenicity: dermal.........................................................................................................16
5.8.3 Summary and discussion of carcinogenicity........................................................................................16
5.9 Toxicity for reproduction.................................................................................................................................17

5.9.1 Effects on fertility.................................................................................................................................17
5.9.2 Developmental toxicity.........................................................................................................................17
5.9.3 Summary and discussion of reproductive toxicity................................................................................17
5.10 Other effects.....................................................................................................................................................17

5.10.1.1 Neurotoxicity..........................................................................................................................17
5.10.1.2 Immunotoxicity......................................................................................................................17
5.10.1.3 Specific investigations: other studies.....................................................................................17
5.10.3 Summary and discussion......................................................................................................................17
Derivation of DNEL(s) /DMELs.....................................................................................................................17

5.11.1 Overview of typical dose descriptors for all endpoints........................................................................17
5.11.2 Correction of dose descriptors if needed (for example route-to-route extrapolation), application of
assessment factors and derivation of the endpoint specific DN(M)EL................................................19
5.11.3 Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative descriptor for critical
health effects.........................................................................................................................................22
6 HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICO-CHEMICAL PROPERTIES...............................24
6.1 Explosivity.......................................................................................................................................................24
6.2 Flammability....................................................................................................................................................24
6.3 Oxidising potential...........................................................................................................................................24
7 ENVIRONMENTAL HAZARD ASSESSMENT...................................................................................................25
7.1 Aquatic compartment (including sediment).....................................................................................................25

7.1.1 Toxicity data.........................................................................................................................................25
7.1.1.1 Fish.........................................................................................................................................25
7.1.1.1.1 Short-term toxicity to fish.....................................................................................25
7.1.1.1.2 Long-term toxicity to fish......................................................................................25
7.1.1.2 Aquatic invertebrates..............................................................................................................25
7.1.1.2.1 Short-term toxicity to aquatic invertebrates..........................................................25
7.1.1.2.2 Long-term toxicity to aquatic invertebrates..........................................................25
7.1.1.3 Algae and aquatic plants.........................................................................................................25
7.1.1.4 Sediment organisms................................................................................................................25
7.1.1.5 Other aquatic organisms.........................................................................................................25
3
7.1.2 Calculation of Predicted No Effect Concentration (PNEC).................................................................25

7.1.2.1 PNEC water............................................................................................................................25
7.1.2.2 PNEC sediment......................................................................................................................26
7.2 Terrestrial compartment...................................................................................................................................26

7.2.1 Toxicity data.........................................................................................................................................26
7.2.1.1 Toxicity to soil macro organisms...........................................................................................26
7.2.1.2 Toxicity to terrestrial plants....................................................................................................26
7.2.1.3 Toxicity to soil micro-organisms............................................................................................26
7.2.1.4 Toxicity to other terrestrial organisms...................................................................................26
7.2.2 Calculation of Predicted No Effect Concentration (PNEC_soil).........................................................26
7.3 Atmospheric compartment...............................................................................................................................26
7.4 Microbiological activity in sewage treatment systems....................................................................................26

7.4.1 Toxicity to aquatic micro-organisms....................................................................................................26
7.4.2 PNEC for sewage treatment plant.........................................................................................................26
7.5 Non compartment specific effects relevant for the food chain (secondary poisoning)...................................27
7.5.1 Toxicity to birds....................................................................................................................................27
7.5.2 Toxicity to mammals............................................................................................................................27
7.5.3 Calculation of PNECoral (secondary poisoning).................................................................................27
7.6 Conclusion on the environmental classification and labelling.........................................................................27
8 PBT AND VPVB ASSESSMENT...........................................................................................................................28
8.1 Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex XIII....................................28
8.1.1 Persistence Assessment........................................................................................................................28
8.1.2 Bioaccumulation Assessment...............................................................................................................28
8.1.3 Toxicity Assessment.............................................................................................................................28
8.1.4 Summary and overall Conclusions on PBT or vPvB Properties..........................................................28
8.2 Emission Characterisation................................................................................................................................28
9 EXPOSURE ASSESSMENT...................................................................................................................................29
9.1 (Title of Exposure scenario 1)..........................................................................................................................31

9.1.1 Exposure scenario.................................................................................................................................31
9.1.1.1 Description of activities and processes covered in the exposure scenario.............................31
9.1.1.2 Operational conditions related to frequency, duration and amount of use.............................31
9.1.1.3 Operational conditions and risk management measures related to product characteristics.. .32
9.1.1.4 Operational conditions related to available dilution capacity and characteristics of exposed
humans....................................................................................................................................32
9.1.1.5 Other operational conditions of use........................................................................................33
9.1.1.6 Risk management measures...................................................................................................33
9.1.1.7 Waste related measures..........................................................................................................34
9.1.2 Exposure estimation.............................................................................................................................34
9.1.2.1 Workers exposure...................................................................................................................34
9.1.2.1.1 Acute/Short term exposure....................................................................................34
9.1.2.1.2 Long-term exposure...............................................................................................35
9.1.2.2 Consumer exposure................................................................................................................36
9.1.2.2.1 Acute/Short term exposure....................................................................................36
9.1.2.2.2 Long-term exposure...............................................................................................36
9.1.2.3 Indirect exposure of humans via the environment (oral)........................................................37
9.1.2.4 Environmental exposure.........................................................................................................38
9.1.2.4.1 Environmental releases..........................................................................................38
9.1.2.4.2 Exposure concentration in sewage treatment plants (STP)...................................39
9.1.2.4.3 Exposure concentration in aquatic pelagic compartment......................................40
9.1.2.4.4 Exposure concentration in sediments....................................................................41
4
9.1.2.4.5 Exposure concentrations in soil and groundwater.................................................42

9.1.2.4.6 Atmospheric compartment....................................................................................42
9.1.2.4.7 Exposure concentration relevant for the food chain (Secondary poisoning)........43
9.2 (Title of exposure scenario 2)..........................................................................................................................44

9.2.1 Exposure scenario.................................................................................................................................44
9.2.2 Exposure estimation.............................................................................................................................44
9.3 Regional exposure concentrations...................................................................................................................45
10 RISK CHARACTERISATION................................................................................................................................46

10.1.1 Human health........................................................................................................................................46
10.1.1.1 Workers..................................................................................................................................46
10.1.1.2 Consumers..............................................................................................................................47
10.1.1.3 Indirect exposure of humans via the environment.................................................................48
10.1.2 Environment.........................................................................................................................................49
10.1.2.1 Aquatic compartment (including sediment and secondary poisoning)..................................49
10.1.2.2 Terrestrial compartment (including secondary poisoning).....................................................49
10.1.2.3 Atmospheric compartment.....................................................................................................50
10.1.2.4 Microbiological activity in sewage treatment systems...........................................................50
10.3 Overall exposure (combined for all relevant emission/release sources)..........................................................50

10.3.1 Human health (combined for all exposure routes)...............................................................................50
10.3.2 Environment (combined for all emission sources)...............................................................................50
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: Corrected dose descriptor(s) per endpoint and endpoint-specific DNEL(s)/DMEL(s) for the relevant
exposure pattern.............................................................................................................................................................20
Table 12: DN(M)ELs for workers..................................................................................................................................22
Table 13: DN(M)ELs for the general population...........................................................................................................22
Table 14: Example table for reporting (robust) study summaries..................................................................................24
Table 15: Example table for reporting (robust) study summaries..................................................................................25
Table 16: PNEC aquatic.................................................................................................................................................25
Table 17: PNEC sediment..............................................................................................................................................26
Table 18: PNEC soil.......................................................................................................................................................26
Table 20: PNEC sewage treatment plant.......................................................................................................................26
Table 21: PNEC oral......................................................................................................................................................27
Table 22: Overview on exposure scenarios and coverage of substance life cycle.........................................................30
Table 23: Acute exposure concentrations to workers....................................................................................................34
Table 24: Summary of acute exposure concentrations to workers................................................................................35
Table 25: Long-term exposure concentrations to workers.............................................................................................35
5
Table 26: Summary of long-term exposure concentration to workers...........................................................................35

Table 27: Acute exposure concentrations to consumers................................................................................................36
Table 28: Summary of acute exposure concentrations to consumers............................................................................36
Table 29: Long term exposure concentrations to consumers.........................................................................................36
Table 30: Summary of long term exposure concentrations to consumers.....................................................................37
Table 31: Concentration for oral exposure of humans via the environment..................................................................37
Table 32: Total daily dose for oral exposure of humans via the environment...............................................................38
Table 33: Releases to the environment..........................................................................................................................38
Table 34: Summary of the releases to the environment.................................................................................................38
Table 35: Concentrations in sewage..............................................................................................................................39
Table 36: Predicted Exposure Concentrations (PEC) in sewage...................................................................................39
Table 37: Local concentrations in water........................................................................................................................40
Table 38: Predicted Exposure Concentrations (PEC) in aquatic compartment.............................................................40
Table 39: Local concentrations in sediment...................................................................................................................41
Table 40: Predicted Exposure Concentrations (PEC) in sediments...............................................................................41
Table 41: Local concentrations in soil...........................................................................................................................42
Table 42: Predicted Exposure Concentrations (PEC) in soil and groundwater.............................................................42
Table 43: Local concentrations in air.............................................................................................................................42
Table 44: Predicted Exposure Concentration (PEC) in air............................................................................................43
Table 45: Local concentration relevant for secondary poisoning..................................................................................43
Table 46: Predicted Exposure Concentration in food (PECoral) for secondary poisoning...........................................44
Table 47: Regional concentrations in the environment..................................................................................................45
Table 48: Regional concentrations in food and drinking water.....................................................................................45
Table 49: (Semi) Quantitative risk characterisation for workers...................................................................................46
Table 50: Qualitative risk characterisation for workers.................................................................................................46
Table 51: (Semi) Quantitative risk characterisation for consumers...............................................................................47
Table 52: Qualitative risk characterisation for consumers.............................................................................................47
Table 53: (Semi) Quantitative risk characterisation for humans exposed via the environment....................................48
Table 54: Qualitative risk characterisation for humans exposed via the environment..................................................49
Table 55: Risk characterisation for the aquatic compartment........................................................................................49
Table 56: Risk characterisation for the terrestrial compartment....................................................................................49
Table 57: Identification of relevant combination of exposure scenarios.......................................................................50
Table 58: Risk characterisation for combined relevant emission..................................................................................50
FIGURES
6
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
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
1.3 Physicochemical properties
Table 5: Overview of physicochemical properties

Property Value Remarks
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
Auto flammability
Reactivity towards container material
Thermal stability
[enter other property or delete row]
9
2 MANUFACTURE AND USES
2.1 Manufacture
2.2 Identified uses

Table 6: Description of identified uses
Identified Preparation Process category Article category
Sector of Use (SoU)
use Category (PC) (PROC) (AC)
2.3 Uses advised against
3 CLASSIFICATION AND LABELLING 1
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.
10
3.2 Self classification(s) and labelling

Table 7: Classification according to Directive 67/548/EEC criteria
Endpoints Classification Reason for no Justification for
classification (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 single 5.2
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
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
12
4.1.4 Environmental distribution
4.1.5 Adsorption/desorption
4.1.6 Volatilisation
4.1.7 Distribution modelling
4.2 Bioaccumulation
4.2.1 Aquatic bioaccumulation
4.2.2 Terrestrial bioaccumulation
4.2.3 Summary and discussion of bioaccumulation
4.3 Secondary poisoning
13
5 HUMAN HEALTH HAZARD ASSESSMENT
could be used.
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
5.2.1.1 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
5.2.3 Summary and discussion of acute toxicity
14
5.3 Irritation
5.3.1 Skin
5.3.1.1 Non-human information
5.3.1.2 Human information
5.3.2 Eye
5.3.3 Respiratory tract
5.3.4 Summary and discussion of irritation
5.4 Corrosivity
5.4.3 Summary and discussion of corrosion
5.5 Sensitisation
5.5.1 Skin
5.5.2 Respiratory system
15
5.5.3 Summary and discussion of sensitisation
5.6 Repeated dose toxicity
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
5.6.3 Summary and discussion of repeated dose toxicity
5.7 Mutagenicity
5.7.1.1 In vitro data
5.7.1.2 In vivo data
5.7.3 Summary and discussion of mutagenicity
5.8 Carcinogenicity
5.8.1.1 Carcinogenicity: oral
5.8.1.2 Carcinogenicity: inhalation
5.8.1.3 Carcinogenicity: dermal
5.8.3 Summary and discussion of carcinogenicity
16
5.9 Toxicity for reproduction
5.9.1 Effects on fertility
5.9.2 Developmental toxicity
5.9.3 Summary and discussion of reproductive toxicity
5.10 Other effects
5.10.1.1 Neurotoxicity
5.10.1.2 Immunotoxicity
5.10.1.3 Specific investigations: other studies
5.10.3 Summary and discussion
5.11 Derivation of DNEL(s) /DMELs 2
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.
17
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
Local 6
Systemic 7
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 toxicity10 oral NA
fertility impairment
dermal NA
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
18
5.11.2 Correction of dose descriptors if needed (for example route-to-route extrapolation),

application of assessment factors and derivation of the endpoint specific DN(M)EL
19
Table 11: Corrected dose descriptor(s) per endpoint and endpoint-specific DNEL(s)/DMEL(s) for the relevant exposure pattern 11
Endpoint Route Most relevant quantitative Corrected dose descriptor Overall AF Endpoint-specific
dose descriptor12 (appropriate unit) applied DNEL/DMEL
(appropriate unit) (appropriate unit)
Local13 Systemic14 Local Systemic Local Systemic
Acute toxicity oral

dermal
inhalation
Irritation/Corrosivity skin NA15 NA NA
eye NA NA NA
resp. tract NA NA NA
Sensitisation skin NA NA NA
resp. tract NA NA NA
Repeated dose toxicity oral
sub-acute/ sub-chronic/
dermal
chronic
inhalation
Mutagenicity in vitro
in vivo
Carcinogenicity oral
dermal
inhalation
11 Repeat as appropriate for the different populations (workers/general population and eventually specific sensitive population)
12 NOAEL (NOAEC), LOAEL , T25, BMD10 etc or any other dose descriptor; indicate whether this concerns a no or lowest observed effect level etc
13 Local exposure: units are mg/m3 for inhalation, and mg/cm2 or ppm for dermal exposure
14 Systemic: units are mg/m3 for inhalation, and mg/kg bw/day for oral and dermal exposure
15 Not Applicable
20
Endpoint Route Most relevant quantitative Corrected dose descriptor Overall AF Endpoint-specific
dose descriptor (appropriate unit) applied DNEL/DMEL
(appropriate unit) (appropriate unit)
Local Systemic Local Systemic Local Systemic
Reproductive toxicity oral NA NA NA

fertility impairment
dermal NA NA NA
inhalation NA NA NA
Reproductive toxicity oral NA NA NA
developmental tox
dermal NA NA NA
inhalation NA NA NA
.
21
5.11.3 Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative

descriptor for critical health effects
Table 12: DN(M)ELs for workers 16
Exposure pattern Route Descriptors17 DNEL/DMEL Most sensitive

(appropriate unit) endpoint
Acute - systemic dermal (mg/kg bw /day)
effects
Inhalation (mg/m3)
Acute - local effects Dermal (mg/cm2)
Inhalation (mg/m3)
Long-term - systemic Dermal (mg/kg bw /day)
effects
Inhalation (mg/m3)
Long-term – local Dermal (mg/cm2)
effects
Inhalation (mg/m3)
Discussion
Table 13: DN(M)ELs for the general population18

Exposure pattern Route Descriptors DNEL/DMEL Most sensitive
(appropriate unit) endpoint
Acute - systemic Dermal (mg/kg bw /day)
effects
Inhalation (mg/m3)
Oral (mg/kg bw /day)
Acute - local effects Dermal (mg/cm2)
Inhalation (mg/m3)
Long-term - systemic dermal(mg/kg bw /day)
effects
Inhalation (mg/m3)
oral(mg/kg bw /day)
Long-term – local Dermal (mg/cm2)
effects
Inhalation (mg/m3)
Discussion
16 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.
17 Values in IUCLID 5 are DNEL/DMEL/ not quantifiable
18 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.
22
23
6 HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL

PROPERTIES
could be used.
6.1 Explosivity
6.2 Flammability
6.3 Oxidising potential
24
7 ENVIRONMENTAL HAZARD ASSESSMENT
could be used.
25
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 16: PNEC aquatic
Value Assessment Remarks/Justification
factor
PNEC aqua – freshwater (mg/l)
PNEC aqua - marine water (mg/l)
PNEC aqua – intermittent releases
(mg/l)
26
7.1.2.2 PNEC sediment

Table 17: 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 18: PNEC soil
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 19: PNEC sewage treatment plant
PNEC stp ( mg/l.)
27
7.5 Non compartment specific effects relevant for the food

chain (secondary poisoning) 19
7.5.1 Toxicity to birds
7.5.2 Toxicity to mammals
7.5.3 Calculation of PNECoral (secondary poisoning)

Table 20: PNEC oral
PNEC oral ( mg/kg food)
7.6 Conclusion on the environmental classification and labelling 20
19 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.
20 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.
28
8 PBT AND VPVB ASSESSMENT
8.1 Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex XIII
8.1.1 Persistence Assessment
8.1.2 Bioaccumulation Assessment
8.1.3 Toxicity Assessment
8.1.4 Summary and overall Conclusions on PBT or vPvB Properties
8.2 Emission Characterisation
29
9 EXPOSURE ASSESSMENT
Overview of exposure scenarios
30
Table 21: Overview on exposure scenarios and coverage of substance life cycle
Resulting
Identified
life cycle
uses
stage
Service life (for

Linked to
ES Volume Preparation Process category Article category
Identified Sector of Use (SU)21
Consumer use
number (tonnes) Category (PC) (PROC) (AC)
Manufacture
Use
Formulation
Waste stage
articles)
End use
ES 1
21 The four descriptors should be consistent with the ones describing the identified use in section 2.2
31
9.1 (Title of Exposure scenario 1)
9.1.1 Exposure scenario
9.1.1.1 Description of activities and processes covered in the exposure scenario
9.1.1.2 Operational conditions related to frequency, duration and amount of use

Example tables have been developed so that information can be reported in a standardised way.
To include the relevant table for your case you can:
click right on the icon
select “document object” and then “select”
click on “display as icon”
Depending on the coverage of the exposure scenario, different type of information might be needed
and therefore several example tables have been developed to cover those different situations. In
most situations only one of those table will be necessary for one exposure scenario.
For ES covering industrial sites (point sources), the following example table for reporting
information is available:
For ES covering professional uses outside industrial sites (wide disperse use and emissions), the
22
following example table for reporting information is available.
For ES covering consumer uses (wide disperse use and emissions), the following example table for
reporting information is available.
22 Professional use is defined here as non consumer use
32
For ES covering exposure related to the article service life.

The substance may have been incorporated into the article during industrial use, professional use or
consumer use of the substance.
If the same ES covers both one of the above cited use of the substance and its service life, the
following example table should be added to the previous selected one.
If the ES only covers the service life of the article, then only the following example table should be
used.
9.1.1.3 Operational conditions and risk management measures related to product 23
characteristics
For substances used on their own or in preparation, the following example table for reporting
For substances incorporated in articles, the following example table for reporting information is
available:
9.1.1.4 Operational conditions related to available dilution capacity and characteristics of

exposed humans
For exposure scenarios covering worker uses, the following example table for reporting information
is available:
For exposure scenarios covering consumer uses, the following example table for reporting
23 “Product” includes substances, preparations and articles
33
Environmental surroundings characteristics

Available water volume per time for dilution (m3/d): 24
9.1.1.5 Other operational conditions of use

Process condition
Releases to air, water and waste before risk management
the following example table for reporting information is available.
9.1.1.6 Risk management measures

Example tables have been developed so that information can be reported in a standardised way.
Depending on the coverage of the exposure scenario, different type of information might be needed
and therefore several example tables have been developed to cover those different situations.
For ES covering industrial sites (point sources) the following example table for reporting
information is available.
For ES covering professional use outside industrial sites (wide disperse use and emissions) the
following example table for reporting information is available.
For ES covering consumer uses (wide disperse use and emissions) the following example table for
reporting information is available.
9.1.1.7 Waste related measures

The following example table for reporting information is available.
24E.g. flow rate of river receiving waste water (emissions from a site or a sewage treatment plant)
34
9.1.2 Exposure estimation
9.1.2.1 Workers exposure
9.1.2.1.1 Acute/Short term exposure

Table 22: Acute exposure concentrations to workers
Estimated
Measured exposure
Exposure
concentrations Explanation / source of measured data
Concentrations
Routes of exposure value unit Value unit
Dermal exposure
Inhalation exposure
Summary of the short-term exposure values.

Table 23: Summary of acute exposure concentrations to workers
Routes of exposure Concentrations Justification
Dermal local exposure
(in mg/cm2)25
Dermal systemic
exposure
(in mg/kg bw/d)
Inhalation exposure
(in mg/m3)26
9.1.2.1.2 Long-term exposure

Table 24: Long-term exposure concentrations to workers
Estimated
Measured exposure
Exposure
Concentrations
Dermal exposure
25 per day or per event, which ever is more relevant

26 during short-term exposure, air concentration ate the workplace
35
Estimated
Measured exposure
Exposure
Concentrations
Inhalation exposure
Summary of the long-term exposure values.

Table 25: Summary of long-term exposure concentration to workers
Dermal local
exposure
(in mg/cm2)
Dermal systemic
exposure
(in mg/kg bw/d)
Inhalation exposure
(in mg/m3)/8h
workday27
9.1.2.2 Consumer exposure
9.1.2.2.1 Acute/Short term exposure

Table 26: Acute exposure concentrations to consumers
Estimated
Measured exposure
Exposure
Routes of exposure concentrations Explanation / source of measured data
Concentrations
value unit Value unit
Oral exposure
Dermal exposure
Inhalation exposure
Summary of the short-term exposure values.
27 air concentration at the workplace
36
Table 27: Summary of acute exposure concentrations to consumers

Oral exposure
(in mg/kg bw/d)
(in mg/cm2)28
Dermal systemic
exposure
(in mg/kg bw/d)
Inhalation exposure
(in mg/m3)29
9.1.2.2.2 Long-term exposure

Table 28: Long term exposure concentrations to consumers
Estimated
Measured exposure
Exposure
Routes of exposure concentrations Explanation / source of measured data
Concentrations
value unit value unit
Oral exposure
Dermal exposure
Inhalation exposure
Summary of the long-term exposure values.

Table 29: Summary of long term exposure concentrations to consumers
Oral exposure
(in mg/kg bw/d)
(in mg/cm2 /d)
Dermal systemic exposure
(in mg/kg bw/d)
Inhalation exposure
(in mg/m3)
28 per day or per event, which ever is more relevant

29 during short-term exposure
37
9.1.2.3 Indirect exposure of humans via the environment (oral)

Table 30: Concentration for oral exposure of humans via the environment
Estimated
exposure Measured exposure
concentrations concentrations Explanation / source of measured data
Wet fish
Drinking water
Meat
Milk
Other
Summary of the exposure concentration in to be used for the risk characterisation of indirect
exposure of man via the environment
Table 31: Total daily dose for oral exposure of humans via the environment
Total daily dose for oral exposure via the
environment (mg/kg bw/d)
Justification
Exposed via local Exposed via local and
concentration regional concentration
9.1.2.4 Environmental exposure

In case the exposure scenario is covering several life stages, the section below has to be repeated to
cover those different life stages within this section.
9.1.2.4.1 Environmental releases

Table 32: Releases to the environment
Predicted Measured release Explanation / source of measured data
Compartments releases (kg/d) (kg/d)
These data correspond to release to sewage
Aquatic (without
STP)
38
Predicted Measured release Explanation / source of measured data

Compartments releases (kg/d) (kg/d)
Aquatic (after These correspond to release to natural waters after
STP) the sewage treatment plant.
Air (direct +
STP)
Soil (direct only)
Summary of the releases taken into account for the exposure estimation.
Table 33: Summary of the releases to the environment
Release from Total release
point source for regional
(kg/d) (local exposure
exposure estimation
Compartments estimation) (kg/d) Justification
Aquatic (without
STP)
Aquatic (after STP)
Air (direct + STP)
Soil (direct releases
only)
9.1.2.4.2 Exposure concentration in sewage treatment plants (STP)

Table 34: Concentrations in sewage
Estimated
exposure Measured exposure
Compartments concentrations concentrations Explanation / source of measured data
Sewage (STP effluent)
Sewage sludge
Summary of the exposure concentration in sewage treatment plants taken into account for further
exposure estimation (water and soil concentrations) or risk characterisation for micro organisms in
the STP
39
Table 35: Predicted Exposure Concentrations (PEC) in sewage

Value Justification
Concentration in sewage
(PECstp)(in mg/l)
Concentration in sewage sludge
(in mg/kg d.w.)
9.1.2.4.3 Exposure concentration in aquatic pelagic compartment

Table 36: Local concentrations in water
Estimated Measured local
exposure exposure

Estimated local exposure concentration
based on…
Estimated predicted exposure
concentration (PEC) = estimated local
exposure concentration + regional
Freshwater concentration (from Table 46)
Measured concentration in…
based on…
Marine water concentration (from Table 46)
Intermittent releases to
water
Summary of the Predicted Exposure Concentrations (PEC) in the aquatic pelagic compartment
taken into account for risk characterisation
Table 37: Predicted Exposure Concentrations (PEC) in aquatic compartment
Local PEC aquatic
Compartments concentration (local+regional) Justification
Freshwater (in mg/l)
Marine water (in mg/l)
Intermittent releases to water (in mg/l)
40
9.1.2.4.4 Exposure concentration in sediments

Table 38: Local concentrations in sediment
exposure exposure

based on…
Estimated predicted exposure concentration
(PEC) = estimated local exposure
concentration + regional concentration
Freshwater sediments (from Table 46)
based on…
Estimated predicted exposure concentration
(PEC) = estimated local exposure
Marine water concentration + regional concentration
sediments (from Table 46)
.
Summary of the exposure concentration in aquatic sediments taken into account for risk
characterisation
Table 39: Predicted Exposure Concentrations (PEC) in sediments
Local PEC sediment
Compartments Justification
concentration (local+regional)
Freshwater sediments
(in mg/kg d.w)
Marine water sediments
(in mg/kg d.w.)
41
9.1.2.4.5 Exposure concentrations in soil and groundwater

Table 40: Local concentrations in soil
exposure exposure

based on…
Agricultural soil exposure concentration + regional
averaged concentration (from Table 46)
Grassland averaged
Groundwater
Summary of the Predicted Exposure Concentration (PEC) in soil taken into account for risk
characterisation
Table 41: Predicted Exposure Concentrations (PEC) in soil and groundwater
Local PEC
concentration soil/groundwater
Justification
(local+regional)
Agricultural soil averaged
(mg/kg ww)
Grassland averaged (mg/kg
ww)
Groundwater(mg/l)
9.1.2.4.6 Atmospheric compartment

Table 42: Local concentrations in air
exposure exposure
During emission
annual average
Annual total
deposition
42
Summary of the Predicted Exposure Concentration in soil taken into account for risk
characterisation
Table 43: Predicted Exposure Concentration (PEC) in air
Local PEC air
Justification
concentration (local+regional)
During emission (μg/m3)
annual average (μg/m3)
Annual deposition (μg/m2/d)
9.1.2.4.7 Exposure concentration relevant for the food chain (Secondary poisoning)
Table 44: Local concentration relevant for secondary poisoning
Predicted Measured local
exposure exposure

based on…
Concentration in food
of fish eating predator
concentration (from Table 46)
based on…
Concentration in food Estimated predicted exposure
of fish eating top- concentration (PEC) = estimated local
predator (marine) exposure concentration + regional
concentration (from Table 46)
Concentration in
earthworm
Summary of the Predicted Exposure Concentration in food for secondary poisoning taken into
account for risk characterisation
43
Table 45: Predicted Exposure Concentration in food (PECoral) for secondary poisoning
Local PEC oral
concentration (local+regional) Justification
PECoral predator (in mg/kg
w.w)
PECoral top predator (in
mg/kg w.w.)
Concentration in earthworm
(in mg/kg w.w.)
9.2 (Title of exposure scenario 2)
9.2.1 Exposure scenario
9.2.2 Exposure estimation
9.3 Regional exposure concentrations 30
Table 46: Regional concentrations in the environment

Predicted
regional Measured regional
Exposure exposure Explanation / source of measured data
Concentrations concentrations
Freshwater
Marine water
Freshwater sediments
Marine sediments
Agricultural soil
Grassland
Air
30 The estimation of regional exposure has to be performed 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.
44
Table 47: Regional concentrations in food and drinking water

Predicted
regional Measured regional
Exposure exposure Explanation / source of measured data
Concentrations concentrations
value unit value Unit
Wet fish
Drinking water
Meat
Milk
45
10 RISK CHARACTERISATION
10.1.1 Human health
10.1.1.1 Workers
Table 48: (Semi) Quantitative risk characterisation for workers
Route ES 1- exposure Leading toxic DN(M)EL31 Risk characterisation
concentrations end point / ratio32
(EC) Critical effect
Acute - Dermal mg/kg bw/d
systemic
Inhalation mg/m3
effects
Acute - local Dermal mg/cm2*
effects
Inhalation mg/m3 **
Combined RCR Inhalation- systemic +
routes RCR Dermal- systemic
Long-term - Dermal mg/kg bw/d
systemic
Inhalation mg/m3
effects
Long-term – Dermal mg/cm2/d
local effects
Inhalation mg/m3 ***
31 The 8 D(M)NELs relevant here can be extracted from IUCLID 5 and are already reported in Table 12.
32 Equal to the ratio of the relevant EC (reported in column 3) to the relevant D(M)NEL (reported in column 5)
46
* per day or event, which ever is more relevant

** same value as “Acute systemic effects-inhalation exposure concentration”
*** same value as “Long-term systemic effects-inhalation exposure concentration”
Table 49: Qualitative risk characterisation for workers
Route ES 1- exposure Leading toxic Qualitative risk characterisation
concentrations end point /
systemic
Inhalation mg/m3
effects
Acute - local Dermal mg/cm2 *
effects
Inhalation mg/m3 **
Combined
routes
systemic
Inhalation mg/m3
effects
Combined
routes
local effects
47

10.1.1.2 Consumers
Table 50: (Semi) Quantitative risk characterisation for consumers
Route ES 1- exposure Leading toxic DN(M)EL33 Risk characterisation ratio34
systemic
Inhalation mg/m3
effects
effects
Inhalation mg/m3 **
Oral mg/kg bw/d
systemic
Inhalation mg/m3
effects
Oral mg/kg bw/d
local effects
33 The 8 D(M)NELs relevant here can be extracted from IUCLID 5 and are already reported in Table 12.
48

Table 51: Qualitative risk characterisation for consumers
Route ES 1- exposure Leading toxic Qualitative risk characterisation
systemic
Inhalation mg/m3
effects
effects
Inhalation mg/m3 **
Oral mg/kg bw/d
Combined
routes
systemic
Inhalation mg/m3
effects
Oral mg/kg bw/d
Combined
routes
local effects
10.1.1.3 Indirect exposure of humans via the environment

Table 52: (Semi) Quantitative risk characterisation for humans exposed via the environment
Route ES 1- exposure Leading toxic end DN(M)EL35 Risk characterisation
concentrations (EC) point / Critical ratio36
effect
Dermal- systemic37 mg/kg bw/d
(acute or long term)
Inhalation- systemic mg/m3
(long term)
Oral- systemic (long mg/kg bw/d
term)
Combined routes RCR Inhalation-
systemic + RCR Oral-
systemic
35 The 8 D(M)NELs relevant here can be extracted from IUCLID 5 and are already reported in Table 12
37 Dermal exposure is rarely relevant for exposure of man via the environment (bathing waters)
49
Table 53: Qualitative risk characterisation for humans exposed via the environment
Route ES 1- exposure Leading toxic end Qualitative risk characterisation
concentrations (EC) point / Critical
effect
Dermal- systemic38 mg/kg bw/d
(acute or long term)
Inhalation- systemic mg/m3
(long term)
Oral- systemic (long mg/kg bw/d
term)
Combined routes RCR Inhalation- systemic + RCR Oral-
systemic
10.1.2 Environment
10.1.2.1 Aquatic compartment (including sediment and secondary poisoning) 39
Table 54: Risk characterisation for the aquatic compartment

Compartments PEC PNEC PEC/PNEC Discussion
Freshwater in mg/l in mg/l
Marine water idem idem
Sediment in mg/kg in mg/kg
Aquatic freshwater in mg/kg
in mg/kg
food chain food
Aquatic marine water
idem idem
food chain
10.1.2.2 Terrestrial compartment (including secondary poisoning) 40
Table 55: Risk characterisation for the terrestrial compartment

Agricultural soil in mg/kg in mg/kg
Grassland idem idem
Terrestrial food in mg/kg
in mg/kg
chain food
38 Dermal exposure is rarely relevant for exposure of man via the environment (bathing waters)
39 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.
40 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.
50
10.1.2.3 Atmospheric compartment
10.1.2.4 Microbiological activity in sewage treatment systems

STP in mg/l in mg/l
10.3 Overall exposure (combined for all relevant emission/release sources)
10.3.1 Human health (combined for all exposure routes)

Table 56: Identification of relevant combination of exposure scenarios
Exposure scenarios Combination 1 Combination 2
ES 1
ES 2
ES 3
Table 57: Risk characterisation for combined relevant emission

Relevant combination of
Risk characterisation ratio
exposure scenario
Combination 1
Combination 2
10.3.2 Environment (combined for all emission sources)
51
REFERENCES
52
ANNEX
53

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CHEMICAL SAFETY REPORT TEMPLATE

CHEMICAL SAFETY REPORT

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

1.1 Name and other identifiers of the substance....................................................................................................8

1.2 Composition of the substance..........................................................................................................................8

1.3 Physico-chemical properties............................................................................................................................9

2 MANUFACTURE AND USES...............................................................................................................................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

4.2 Environmental distribution..............................................................................................................................13

4.2.3 Distribution modelling..........................................................................................................................13

4.4 Secondary poisoning........................................................................................................................................13

5 HUMAN HEALTH HAZARD ASSESSMENT......................................................................................................14

5.1 Toxicokinetics (absorption, metabolism, distribution and elimination)..........................................................14

5.2 Acute toxicity...................................................................................................................................................14

5.6 Repeated dose toxicity.....................................................................................................................................16

5.9 Toxicity for reproduction.................................................................................................................................17

5.10 Other effects.....................................................................................................................................................17

Derivation of DNEL(s) /DMELs.....................................................................................................................17

6 HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICO-CHEMICAL PROPERTIES...............................24

6.3 Oxidising potential...........................................................................................................................................24

7 ENVIRONMENTAL HAZARD ASSESSMENT...................................................................................................25

7.1 Aquatic compartment (including sediment).....................................................................................................25

7.1.2 Calculation of Predicted No Effect Concentration (PNEC).................................................................25

7.2 Terrestrial compartment...................................................................................................................................26

7.3 Atmospheric compartment...............................................................................................................................26

7.4 Microbiological activity in sewage treatment systems....................................................................................26

7.6 Conclusion on the environmental classification and labelling.........................................................................27

8 PBT AND VPVB ASSESSMENT...........................................................................................................................28

8.2 Emission Characterisation................................................................................................................................28

9.1 (Title of Exposure scenario 1)..........................................................................................................................31

9.1.2.4.5 Exposure concentrations in soil and groundwater.................................................42

9.2 (Title of exposure scenario 2)..........................................................................................................................44

9.3 Regional exposure concentrations...................................................................................................................45

10.1 (Title of exposure scenario 1)..........................................................................................................................46

10.2 (Title of exposure scenario 2)..........................................................................................................................50

10.3 Overall exposure (combined for all relevant emission/release sources)..........................................................50

Table 26: Summary of long-term exposure concentration to workers...........................................................................35

1 SUMMARY OF RISK MANAGEMENT MEASURES

2 DECLARATION THAT RISK MANAGEMENT MEASURES ARE

3 DECLARATION THAT RISK MANAGEMENT MEASURES ARE

1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL

1.1 Name and other identifiers of the substance

CAS number (EC inventory):

Annex I index number

Molecular weight range:

1.2 Composition of the substance

1.3 Physicochemical properties

Table 5: Overview of physicochemical properties

2 MANUFACTURE AND USES

2.2 Identified uses