CLH report

Proposal for Harmonised Classification and Labelling

Based on Regulation (EC) No 1272/2008 (CLP Regulation), 
Annex VI, Part 2

Substance Name: 

EC Number:	
CAS Number:	
Index Number:	

Contact details for dossier submitter: 

Version number:  			Date:  		

CONTENTS

Part A. 
1	proposal for harmonised classification and labelling
1.1	Substance
1.2	Harmonised classification and labelling proposal
1.3	Proposed harmonised classification and labelling based on CLP Regulation and/or DSD criteria
2	BACKGROUND TO THE CLH PROPOSAL
2.1	History of the previous classification and labelling
2.2	Short summary of the scientific justification for the CLH proposal
2.3	Current harmonised classification and labelling
2.3.1	Current classification and labelling in Annex VI, Table 3.1 in the CLP Regulation
2.3.2	Current classification and labelling in Annex VI, Table 3.2 in the CLP Regulation
2.4	Current self-classification and labelling
2.4.1	Current self-classification and labelling based on the CLP Regulation criteria
2.4.2	Current self-classification and labelling based on DSD criteria
3	jUSTIFICATION THAT ACTION IS needeD at COMMUNITY level

Part B
scientific evaluation of the data
1	identity of the substance
1.1	Name and other identifiers of the substance
1.2	Composition of the substance
1.2.1	Composition of test material
1.3	Physico-chemical properties
2	maNufacture and uses
2.1	Manufacture
2.2	Identified uses
3	classification for physico-chemical properties
3.1	[Insert hazard class when relevant and repeat section if needed]
3.1.1	Summary and discussion of
3.1.2	Comparison with criteria
3.1.3	Conclusions on classification and labelling
4	Human health hazard assessment
4.1	Toxicokinetics (absorption, metabolism, distribution and elimination)
4.1.1	Non-human information
4.1.2	Human information
4.1.3	Summary and discussion on toxicokinetics
4.2	Acute toxicity
4.2.1	Non-human information
4.2.1.1	Acute toxicity: oral
4.2.1.2	Acute toxicity: inhalation
4.2.1.3	Acute toxicity: dermal
4.2.1.4	Acute toxicity: other routes
4.2.2	Human information
4.2.3	Summary and discussion of acute toxicity
4.2.4	Comparison with criteria
4.2.5	Conclusions on classification and labelling
4.3	Specific target organ toxicity – single exposure (STOT SE)
4.3.1	Summary and discussion of Specific target organ toxicity – single exposure
4.3.2	Comparison with criteria
4.3.3	Conclusions on classification and labelling
4.4	Irritation
4.4.1	Skin irritation
4.4.1.1	Non-human information
4.4.1.2	Human information
4.4.1.3	Summary and discussion of skin irritation
4.4.1.4	Comparison with criteria
4.4.1.5	Conclusions on classification and labelling
4.4.2	Eye irritation
4.4.2.1	Non-human information
4.4.2.2	Human information
4.4.2.3	Summary and discussion of eye irritation
4.4.2.4	Comparison with criteria
4.4.2.5	Conclusions on classification and labelling
4.4.3	Respiratory tract irritation
4.4.3.1	Non-human information
4.4.3.2	Human information
4.4.3.3	Summary and discussion of respiratory tract irritation
4.4.3.4	Comparison with criteria
4.4.3.5	Conclusions on classification and labelling
4.5	Corrosivity
4.5.1	Non-human information
4.5.2	Human information
4.5.3	Summary and discussion of corrosivity
4.5.4	Comparison with criteria
4.5.5	Conclusions on classification and labelling
4.6	Sensitisation
4.6.1	Skin sensititsation
4.6.1.1	Non-human information
4.6.1.2	Human information
4.6.1.3	Summary and discussion of skin sensitisation
4.6.1.4	Comparison with criteria
4.6.1.5	Conclusions on classification and labelling
4.6.2	Respiratory sensitisation
4.6.2.1	Non-human information
4.6.2.2	Human information
4.6.2.3	Summary and discussion of respiratory sensitisation
4.6.2.4	Comparison with criteria
4.6.2.5	Conclusions on classification and labelling
4.7	Repeated dose toxicity
4.7.1	Non-human information
4.7.1.1	Repeated dose toxicity: oral
4.7.1.2	Repeated dose toxicity: inhalation
4.7.1.3	Repeated dose toxicity: dermal
4.7.1.4	Repeated dose toxicity: other routes
4.7.1.5	Human information
4.7.1.6	Other relevant information
4.7.1.7	Summary and discussion of repeated dose toxicity
4.7.1.8	Summary and discussion of repeated dose toxicity findings relevant for classification according to DSD
4.7.1.9	Comparison with criteria of repeated dose toxicity findings relevant for classification according to DSD
4.7.1.10	Conclusions on classification and labelling of repeated dose toxicity findings relevant for classification according to DSD
4.8	Specific target organ toxicity (CLP Regulation) – repeated exposure (STOT RE)
4.8.1	Summary and discussion of repeated dose toxicity findings relevant for classification as STOT RE according to CLP Regulation
4.8.2	Comparison with criteria of repeated dose toxicity findings relevant for classification as STOT RE
4.8.3	Conclusions on classification and labelling of repeated dose toxicity findings relevant for classification as STOT RE
4.9	Germ cell mutagenicity (Mutagenicity)
4.9.1	Non-human information
4.9.1.1	In vitro data
4.9.1.2	In vivo data
4.9.2	Human information
4.9.3	Other relevant information
4.9.4	Summary and discussion of mutagenicity
4.9.5	Comparison with criteria
4.9.6	Conclusions on classification and labelling
4.10	Carcinogenicity
4.10.1	Non-human information
4.10.1.1	Carcinogenicity: oral
4.10.1.2	Carcinogenicity: inhalation
4.10.1.3	Carcinogenicity: dermal
4.10.2	Human information
4.10.3	Other relevant information
4.10.4	Summary and discussion of carcinogenicity
4.10.5	Comparison with criteria
4.10.6	Conclusions on classification and labelling
4.11	Toxicity for reproduction
4.11.1	Effects on fertility
4.11.1.1	Non-human information
4.11.1.2	Human information
4.11.2	Developmental toxicity
4.11.2.1	Non-human information
4.11.2.2	Human information
4.11.3	Other relevant information
4.11.4	Summary and discussion of reproductive toxicity
4.11.5	Comparison with criteria
4.11.6	Conclusions on classification and labelling
4.12	Other effects
4.12.1	Non-human information
4.12.1.1	Neurotoxicity
4.12.1.2	Immunotoxicity
4.12.1.3	Specific investigations: other studies
4.12.1.4	Human information
4.12.2	Summary and discussion
4.12.3	Comparison with criteria
4.12.4	Conclusions on classification and labelling
5	environmental hazard assessment
5.1	Degradation
5.1.1	Stability
5.1.2	Biodegradation
5.1.2.1	Biodegradation estimation
5.1.2.2	Screening tests
5.1.2.3	Simulation tests
5.1.3	Summary and discussion of degradation
5.2	Environmental distribution
5.2.1	Adsorption/Desorption
5.2.2	Volatilisation
5.2.3	Distribution modelling
5.3	Aquatic Bioaccumulation
5.3.1	Aquatic bioaccumulation
5.3.1.1	Bioaccumulation estimation
5.3.1.2	Measured bioaccumulation data
5.3.2	Summary and discussion of aquatic bioaccumulation
5.4	Aquatic toxicity
5.4.1	Fish
5.4.1.1	Short-term toxicity to fish
5.4.1.2	Long-term toxicity to fish
5.4.2	Aquatic invertebrates
5.4.2.1	Short-term toxicity to aquatic invertebrates
5.4.2.2	Long-term toxicity to aquatic invertebrates
5.4.3	Algae and aquatic plants
5.4.4	Other aquatic organisms (including sediment)
5.5	Comparison with criteria for environmental hazards (sections 5.1 – 5.4)
5.6	Conclusions on classification and labelling for environmental hazards (sections 5.1 – 5.4)
6	other information
7	references
8	Annexes

Part A.
1	proposal for harmonised classification and labelling
1.1	Substance 

Table 1: 	Substance identity
Substance name:		
EC number:		
CAS number:		
Annex VI Index number:		
Degree of purity:		
Impurities:		

1.2	 Harmonised classification and labelling proposal

Table 2: 	The current Annex VI entry and the proposed harmonised classification 
	CLP Regulation	Directive 67/548/EEC (Dangerous Substances Directive; DSD)	
Current entry in Annex VI, CLP Regulation			
Current proposal for consideration by RAC			
Resulting harmonised classification (future entry in Annex VI, CLP Regulation)			

1.3	
Proposed harmonised classification and labelling based on CLP Regulation and/or DSD criteria

Table 3: 	Proposed classification according to the CLP Regulation
CLP Annex I ref	Hazard class	Proposed classification	Proposed SCLs  and/or M-factors	Current classification 1)	Reason for no classification 2)	
2.1.	Explosives					
2.2.	Flammable gases 					
2.3. 	Flammable aerosols					
2.4. 	Oxidising gases					
2.5.	Gases under pressure					
2.6.	Flammable liquids					
2.7. 	Flammable solids 					
2.8.	Self-reactive substances and mixtures					
2.9.	Pyrophoric liquids					
2.10.	Pyrophoric solids					
2.11.	Self-heating substances and mixtures					
2.12.	Substances and mixtures which in contact with water emit flammable gases					
2.13.	Oxidising liquids					
2.14.	Oxidising solids					
2.15. 	Organic peroxides					
2.16.	Substance and mixtures corrosive to metals					
3.1.	Acute toxicity - oral					
	Acute toxicity - dermal					
	Acute toxicity - inhalation					
3.2.	Skin corrosion / irritation					
3.3.	Serious eye damage / eye irritation					
3.4.	Respiratory sensitisation					
3.4.	Skin sensitisation					
3.5.	Germ cell mutagenicity 					
3.6. 	Carcinogenicity					
3.7.	Reproductive toxicity					
3.8.	Specific target organ toxicity –single exposure					
3.9.	Specific target organ toxicity – repeated exposure					
3.10.	Aspiration hazard					
4.1.	Hazardous to the aquatic environment 					
5.1.	Hazardous to the ozone layer					
1) Including specific concentration limits (SCLs) and M-factors
2) Data lacking, inconclusive, or conclusive but not sufficient for classification
Labelling:	Signal word: 
Hazard statements: 
Precautionary statements:

Proposed notes assigned to an entry: 

Table 4: 	Proposed classification according to DSD 
Hazardous property
	Proposed classification	Proposed SCLs	Current classification 1)	Reason for no classification 2)	
Explosiveness					
Oxidising  properties					
Flammability					
Other physico-chemical properties
[Add rows when relevant]					
Thermal stability					
Acute toxicity					
Acute toxicity – irreversible damage after single exposure					
Repeated dose toxicity					
Irritation / Corrosion					
Sensitisation					
Carcinogenicity					
Mutagenicity – Genetic toxicity					
Toxicity to reproduction  – fertility					
Toxicity to reproduction – development					
Toxicity to reproduction – breastfed babies. Effects on or via lactation					
Environment					
1) Including SCLs 
2) Data lacking, inconclusive, or conclusive but not sufficient for classification

Labelling:	Indication of danger: 
R-phrases: 
S-phrases: 
2	
BACKGROUND TO THE CLH PROPOSAL
2.1	History of the previous classification and labelling
2.2	Short summary of the scientific justification for the CLH proposal 
2.3	Current harmonised classification and labelling 
2.3.1	Current classification and labelling in Annex VI, Table 3.1 in the CLP Regulation
2.3.2	Current classification and labelling in Annex VI, Table 3.2 in the CLP Regulation 
2.4	Current self-classification and labelling 
2.4.1	Current self-classification and labelling based on the CLP Regulation criteria
2.4.2	Current self-classification and labelling based on DSD criteria 

3	jUSTIFICATION THAT ACTION IS needeD at COMMUNITY level

	

Part B.

scientific evaluation of the data

1	identity of the substance 
1.1	Name and other identifiers of the substance

Table 5: 	Substance identity
EC number:		
EC name:		
CAS number (EC inventory):		
CAS number:		
CAS name:		
IUPAC name:		
CLP Annex VI Index number:		
Molecular formula:		
Molecular weight range:		

Structural formula:

1.2	Composition of the substance

Table 6: 	Constituents (non-confidential information)
Constituent	Typical concentration	Concentration range	Remarks	

Current Annex VI entry:

Table 7: 	Impurities (non-confidential information)
Impurity	Typical concentration	Concentration range	Remarks	

Current Annex VI entry:

Table 8: 	Additives (non-confidential information)
Additive	Function	Typical concentration	Concentration range	Remarks	

Current Annex VI entry:

1.2.1	Composition of test material
1.3	Physico-chemical properties

Table 9: Summary of physico - chemical properties 
Property	Value	Reference 	Comment (e.g. measured or estimated)	
State of the substance 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				
Flash point				
Flammability				
Explosive properties				
Self-ignition temperature				
Oxidising properties				
Granulometry				
Stability in organic solvents and identity of relevant degradation products				
Dissociation constant				
Viscosity				

2	maNufacture and uses
2.1	Manufacture
2.2	Identified uses

3	classification for physico-chemical properties

Table 10: 	Summary table for relevant physico-chemical studies
Method	Results	Remarks	Reference	

				

3.1	[Insert hazard class when relevant and repeat section if needed] 
3.1.1	Summary and discussion of 
3.1.2	Comparison with criteria
3.1.3	Conclusions on classification and labelling

4	Human health hazard assessment
4.1	Toxicokinetics (absorption, metabolism, distribution and elimination)
4.1.1	Non-human information
4.1.2	Human information
4.1.3	Summary and discussion on toxicokinetics

4.2	Acute toxicity

Table 11: 	Summary table of relevant acute toxicity studies
Method	Results	Remarks	Reference	

				

4.2.1	Non-human information
4.2.1.1	Acute toxicity: oral
4.2.1.2	Acute toxicity: inhalation
4.2.1.3	Acute toxicity: dermal
4.2.1.4	Acute toxicity: other routes
4.2.2	Human information
4.2.3	Summary and discussion of acute toxicity
4.2.4	Comparison with criteria
4.2.5	Conclusions on classification and labelling
4.3	Specific target organ toxicity – single exposure (STOT SE)
4.3.1	Summary and discussion of Specific target organ toxicity – single exposure 
4.3.2	Comparison with criteria
4.3.3	Conclusions on classification and labelling

4.4	Irritation
4.4.1	Skin irritation

Table 12: 	Summary table of relevant skin irritation studies
Method	Results	Remarks	Reference	

				

4.4.1.1	Non-human information
4.4.1.2	Human information
4.4.1.3	Summary and discussion of skin irritation
4.4.1.4	Comparison with criteria
4.4.1.5	Conclusions on classification and labelling

4.4.2	Eye irritation

Table 13: 	Summary table of relevant eye irritation studies
Method	Results	Remarks	Reference	

				

4.4.2.1	Non-human information
4.4.2.2	Human information
4.4.2.3	Summary and discussion of eye irritation
4.4.2.4	Comparison with criteria
4.4.2.5	Conclusions on classification and labelling

4.4.3	Respiratory tract irritation
4.4.3.1	Non-human information
4.4.3.2	Human information
4.4.3.3	Summary and discussion of respiratory tract irritation
4.4.3.4	Comparison with criteria
4.4.3.5	Conclusions on classification and labelling

4.5	Corrosivity

Table 14: 	Summary table of relevant corrosivity studies
Method	Results	Remarks	Reference	

				
4.5.1	Non-human information
4.5.2	Human information
4.5.3	Summary and discussion of corrosivity
4.5.4	Comparison with criteria
4.5.5	Conclusions on classification and labelling

4.6	Sensitisation
4.6.1	Skin sensititsation

Table 15: 	Summary table of relevant skin sensitisation studies
Method	Results	Remarks	Reference	

				

4.6.1.1	Non-human information
4.6.1.2	Human information
4.6.1.3	Summary and discussion of skin sensitisation
4.6.1.4	Comparison with criteria
4.6.1.5	Conclusions on classification and labelling

4.6.2	Respiratory sensitisation

Table 16: 	Summary table of relevant respiratory sensitisation studies
Method	Results	Remarks	Reference	

				

4.6.2.1	Non-human information
4.6.2.2	Human information
4.6.2.3	Summary and discussion of respiratory sensitisation
4.6.2.4	Comparison with criteria
4.6.2.5	Conclusions on classification and labelling

4.7	Repeated dose toxicity
Table 17: 	Summary table of relevant repeated dose toxicity studies
Method	Results	Remarks	Reference	

				
4.7.1	Non-human information
4.7.1.1	Repeated dose toxicity: oral
4.7.1.2	Repeated dose toxicity: inhalation
4.7.1.3	Repeated dose toxicity: dermal
4.7.1.4	Repeated dose toxicity: other routes
4.7.1.5	Human information
4.7.1.6	Other relevant information
4.7.1.7	Summary and discussion of repeated dose toxicity
4.7.1.8	Summary and discussion of repeated dose toxicity findings relevant for classification according to DSD 
4.7.1.9	Comparison with criteria of repeated dose toxicity findings relevant for classification according to DSD
4.7.1.10	Conclusions on classification and labelling of repeated dose toxicity findings relevant for classification according to DSD

4.8	Specific target organ toxicity (CLP Regulation) – repeated exposure (STOT RE)
4.8.1	Summary and discussion of repeated dose toxicity findings relevant for classification as STOT RE according to CLP Regulation
4.8.2	Comparison with criteria of repeated dose toxicity findings relevant for classification as STOT RE 
4.8.3	Conclusions on classification and labelling of repeated dose toxicity findings relevant for classification as STOT RE 

4.9	Germ cell mutagenicity (Mutagenicity)

Table 18: 	Summary table of relevant in vitro and in vivo mutagenicity studies
Method	Results	Remarks	Reference	

				

4.9.1	Non-human information
4.9.1.1	In vitro data
4.9.1.2	In vivo data
4.9.2	Human information
4.9.3	Other relevant information
4.9.4	Summary and discussion of mutagenicity
4.9.5	Comparison with criteria
4.9.6	Conclusions on classification and labelling

4.10	Carcinogenicity
Table 19: 	Summary table of relevant carcinogenicity studies
Method	Results	Remarks	Reference	

				

4.10.1	Non-human information
4.10.1.1	Carcinogenicity: oral
4.10.1.2	Carcinogenicity: inhalation
4.10.1.3	Carcinogenicity: dermal
4.10.2	Human information
4.10.3	Other relevant information
4.10.4	Summary and discussion of carcinogenicity
4.10.5	Comparison with criteria
4.10.6	Conclusions on classification and labelling

4.11	Toxicity for reproduction

Table 20: 	Summary table of relevant reproductive toxicity studies
Method	Results	Remarks	Reference	

				

4.11.1	Effects on fertility
4.11.1.1	Non-human information
4.11.1.2	Human information
4.11.2	Developmental toxicity
4.11.2.1	Non-human information
4.11.2.2	Human information
4.11.3	Other relevant information
4.11.4	Summary and discussion of reproductive toxicity
4.11.5	Comparison with criteria
4.11.6	Conclusions on classification and labelling

4.12	Other effects
4.12.1	Non-human information
4.12.1.1	Neurotoxicity
4.12.1.2	Immunotoxicity
4.12.1.3	Specific investigations: other studies
4.12.1.4	Human information
4.12.2	Summary and discussion
4.12.3	Comparison with criteria
4.12.4	Conclusions on classification and labelling

5	environmental hazard assessment
5.1	Degradation

Table 21: 	Summary of relevant information on degradation
Method	Results	Remarks	Reference	

				
				
5.1.1	Stability
5.1.2	Biodegradation
5.1.2.1	Biodegradation estimation
5.1.2.2	Screening tests
5.1.2.3	Simulation tests
5.1.3	Summary and discussion of degradation
5.2	Environmental distribution
5.2.1	Adsorption/Desorption
5.2.2	Volatilisation
5.2.3	Distribution modelling
5.3	Aquatic Bioaccumulation

Table 22: 	Summary of relevant information on aquatic bioaccumulation
Method	Results	Remarks	Reference	

				
				
5.3.1	Aquatic bioaccumulation
5.3.1.1	Bioaccumulation estimation
5.3.1.2	Measured bioaccumulation data
5.3.2	Summary and discussion of aquatic bioaccumulation
5.4	Aquatic toxicity

Table 23: Summary of relevant information on aquatic toxicity
Method	Results	Remarks	Reference	

				
				
5.4.1	Fish
5.4.1.1	Short-term toxicity to fish
5.4.1.2	Long-term toxicity to fish
5.4.2	Aquatic invertebrates
5.4.2.1	Short-term toxicity to aquatic invertebrates
5.4.2.2	Long-term toxicity to aquatic invertebrates
5.4.3	Algae and aquatic plants
5.4.4	Other aquatic organisms (including sediment)
5.5	Comparison with criteria for environmental hazards (sections 5.1 – 5.4)
5.6	Conclusions on classification and labelling for environmental hazards (sections 5.1 – 5.4)

6	other information

7	references

8	Annexes