CLH REPORT FOR LITHIUM SALTS CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: [1] Lithium carbonate; [2] lithium chloride; [3] lithium hydroxide EC Number: [1] 209-062-5; [2] 231-212-3; [3] 215-183-4 CAS Number: [1] 554-13-2; [2] 7447-41-8; [3] 1310-65-2 Index Number: - Contact details for dossier submitter: ANSES (on behalf of the French MSCA) 14 rue Pierre Marie Curie F-94701 Maisons-Alfort Cedex [email protected] Version number: 02 Date: June 2020 CLH REPORT FOR LITHIUM SALTS CONTENTS 1 IDENTITY OF THE SUBSTANCE........................................................................................................................1 1.1 NAME AND OTHER IDENTIFIERS OF THE SUBSTANCES .............................................................................................1 1.1.1 Lithium carbonate ........................................................................................................................................1 1.1.2 Lithium chloride ...........................................................................................................................................2 1.1.3 Lithium hydroxide.........................................................................................................................................3 1.2 COMPOSITION OF THE SUBSTANCE..........................................................................................................................3 2 PROPOSED HARMONISED CLASSIFICATION AND LABELLING............................................................6 2.1 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ACCORDING TO THE CLP CRITERIA............................6 3 HISTORY OF THE PREVIOUS CLASSIFICATION AND LABELLING ......................................................8 4 JUSTIFICATION THAT ACTION IS NEEDED AT COMMUNITY LEVEL.................................................8 5 IDENTIFIED USES..................................................................................................................................................8 6 DATA SOURCES .....................................................................................................................................................8 7 PHYSICOCHEMICAL PROPERTIES .................................................................................................................9 8 EVALUATION OF PHYSICAL HAZARDS.......................................................................................................12 9 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ............13 9.1 SHORT SUMMARY AND OVERALL RELEVANCE OF THE PROVIDED TOXICOKINETIC INFORMATION ON THE PROPOSED CLASSIFICATION(S)........................................................................................................................................13 10 EVALUATION OF HEALTH HAZARDS ..........................................................................................................15 10.1 ACUTE TOXICITY - ORAL ROUTE.......................................................................................................................15 10.2 ACUTE TOXICITY - DERMAL ROUTE..................................................................................................................15 10.3 ACUTE TOXICITY - INHALATION ROUTE ...........................................................................................................15 10.4 SKIN CORROSION/IRRITATION ..........................................................................................................................15 10.5 SERIOUS EYE DAMAGE/EYE IRRITATION...........................................................................................................15 10.6 RESPIRATORY SENSITISATION ..........................................................................................................................15 10.7 SKIN SENSITISATION.........................................................................................................................................15 10.8 GERM CELL MUTAGENICITY.............................................................................................................................16 10.8.1 Short summary and overall relevance of the provided information on germ cell mutagenicity ...........21 10.8.2 Comparison with the CLP criteria ........................................................................................................23 10.8.3 Conclusion on classification and labelling for germ cell mutagenicity ................................................24 10.9 CARCINOGENICITY...........................................................................................................................................24 10.9.1 Short summary and overall relevance of the provided information on carcinogenicity .......................27 10.9.2 Comparison with the CLP criteria ........................................................................................................29 10.9.3 Conclusion on classification and labelling for carcinogenicity............................................................30 10.10 REPRODUCTIVE TOXICITY ................................................................................................................................31 10.10.1 Adverse effects on sexual function and fertility .....................................................................................31 10.10.2 Short summary and overall relevance of the provided information on adverse effects on sexual function and fertility..................................................................................................................................................35 10.10.3 Comparison with the CLP criteria ........................................................................................................41 10.10.4 Adverse effects on development.............................................................................................................42 10.10.5 Short summary and overall relevance of the provided information on adverse effects on development 49 10.10.6 Comparison with the CLP criteria ........................................................................................................57 10.10.7 Adverse effects on or via lactation.........................................................................................................58 10.10.8 Short summary and overall relevance of the provided information on effects on or via lactation .......58 10.10.9 Comparison with the CLP criteria ........................................................................................................60 10.10.10 Conclusion on classification and labelling for reproductive toxicity....................................................61 10.11 SPECIFIC TARGET ORGAN TOXICITY-SINGLE EXPOSURE ...................................................................................63 10.12 SPECIFIC TARGET ORGAN TOXICITY-REPEATED EXPOSURE ..............................................................................63 CLH REPORT FOR LITHIUM SALTS 10.13 ASPIRATION HAZARD .......................................................................................................................................63 11 EVALUATION OF ENVIRONMENTAL HAZARDS.......................................................................................63 12 EVALUATION OF ADDITIONAL HAZARDS .................................................................................................63 13 ADDITIONAL LABELLING................................................................................................................................63 14 ANNEXES ...............................................................................................................................................................63 15 REFERENCES........................................................................................................................................................63 CLH REPORT FOR LITHIUM SALTS 1 IDENTITY OF THE SUBSTANCE 1.1 Name and other identifiers of the substances 1.1.1 Lithium carbonate Table 1: Substance identity and information related to molecular and structural formula of the substance Name(s) in the IUPAC nomenclature or other Lithium carbonate, Dilithium carbonate international chemical name(s) Other names (usual name, trade name, abbreviation) Lithium carbonate, Carbonic acid lithium salt (Li2CO3), Carbolithum, Priadel, Theralite, Plenur, Phasal, Manialith, Maniprex, Eskalith, Camcolit ISO common name (if available and appropriate) Not applicable EC number (if available and appropriate) 209-062-5 EC name (if available and appropriate) Lithium carbonate CAS number (if available) 554-13-2 Other identity code (if available) ICSC number: 1109, RTECS number: OJ5800000 Molecular formula Li2CO3 Structural formula SMILES notation (if available) C(=O)([O-])[O-].[Li+].[Li+] Molecular weight or molecular weight range 73.888 g/mol Information on optical activity and typical ratio of Not applicable (stereo) isomers (if applicable and appropriate) Description of the manufacturing process and identity Not applicable of the source (for UVCB substances only) Degree of purity (%) (if relevant for the entry in Annex No impurities or additives relevant for classification VI) 1 CLH REPORT FOR LITHIUM SALTS 1.1.2 Lithium chloride Table 2: Substance identity and information