CLH REPORT FOR 4-METHYLPENTAN-2-ONE CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: 4-methylpentan-2-one; isobutyl methyl ketone EC Number: 203-550-1 CAS Number: 108-10-1 Index Number: 606-004-00-4 Contact details for dossier submitter: Environment Agency Austria, Spittelauer Lände 5, A-1090 Vienna on behalf of the Austrian Competent Authority (Austrian Federal Ministry of Agriculture, Forestry, Environment and Water Management, Stubenring 1, 1010 Vienna, Austria) Version number: 02 Date: September 2018 CLH REPORT FOR 4-METHYLPENTAN-2-ONE CONTENTS 1 IDENTITY OF THE SUBSTANCE........................................................................................................................1 1.1 NAME AND OTHER IDENTIFIERS OF THE SUBSTANCE...............................................................................................1 1.2 COMPOSITION OF THE SUBSTANCE..........................................................................................................................1 2 PROPOSED HARMONISED CLASSIFICATION AND LABELLING............................................................2 2.1 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ACCORDING TO THE CLP CRITERIA............................2 3 HISTORY OF THE PREVIOUS CLASSIFICATION AND LABELLING ......................................................4 4 JUSTIFICATION THAT ACTION IS NEEDED AT COMMUNITY LEVEL.................................................4 5 IDENTIFIED USES..................................................................................................................................................4 6 DATA SOURCES .....................................................................................................................................................5 7 PHYSICOCHEMICAL PROPERTIES .................................................................................................................6 8 EVALUATION OF PHYSICAL HAZARDS.........................................................................................................6 9 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ..............7 9.1 SHORT SUMMARY AND OVERALL RELEVANCE OF THE PROVIDED TOXICOKINETIC INFORMATION ON THE PROPOSED CLASSIFICATION(S)..........................................................................................................................................8 10 EVALUATION OF HEALTH HAZARDS ............................................................................................................9 10.1.1 Short summary and overall relevance of the provided information on acute oral toxicity.....................9 10.1.2 Comparison with the CLP criteria ........................................................................................................10 10.1.3 Conclusion on classification and labelling for acute oral toxicity........................................................10 10.2 ACUTE TOXICITY - DERMAL ROUTE..................................................................................................................10 10.2.1 Short summary and overall relevance of the provided information on acute dermal toxicity ..............10 10.2.2 Comparison with the CLP criteria ........................................................................................................11 10.2.3 Conclusion on classification and labelling for acute dermal toxicity ...................................................11 10.3 ACUTE TOXICITY - INHALATION ROUTE ...........................................................................................................11 10.3.1 Short summary and overall relevance of the provided information on acute inhalation toxicity .........12 10.3.2 Comparison with the CLP criteria ........................................................................................................13 10.3.3 Conclusion on classification and labelling for acute inhalation toxicity..............................................13 10.4 SKIN CORROSION/IRRITATION ..........................................................................................................................13 10.4.1 Short summary and overall relevance of the provided information on skin corrosion/irritation .........14 10.4.2 Comparison with the CLP criteria ........................................................................................................15 10.4.3 Conclusion on classification and labelling for skin corrosion/irritation ..............................................15 10.5 SERIOUS EYE DAMAGE/EYE IRRITATION...........................................................................................................15 10.5.1 Short summary and overall relevance of the provided information on serious eye damage/eye irritation 17 10.5.2 Comparison with the CLP criteria ........................................................................................................18 10.5.3 Conclusion on classification and labelling for serious eye damage/eye irritation ...............................19 10.6 RESPIRATORY SENSITISATION ..........................................................................................................................19 10.7 SKIN SENSITISATION.........................................................................................................................................19 10.7.1 Short summary and overall relevance of the provided information on skin sensitisation.....................19 10.7.2 Comparison with the CLP criteria ........................................................................................................19 10.7.3 Conclusion on classification and labelling for skin sensitisation .........................................................20 10.8 GERM CELL MUTAGENICITY.............................................................................................................................20 10.8.1 Short summary and overall relevance of the provided information on germ cell mutagenicity ...........22 10.8.2 Comparison with the CLP criteria ........................................................................................................24 10.8.3 Conclusion on classification and labelling for germ cell mutagenicity ................................................25 10.9 CARCINOGENICITY...........................................................................................................................................25 10.9.1 Short summary and overall relevance of the provided information on carcinogenicity .......................26 10.9.2 Comparison with the CLP criteria ........................................................................................................41 10.9.3 Conclusion on classification and labelling for carcinogenicity............................................................42 CLH REPORT FOR 4-METHYLPENTAN-2-ONE 10.10 REPRODUCTIVE TOXICITY ................................................................................................................................43 10.10.1 Adverse effects on sexual function and fertility .....................................................................................43 10.10.2 Short summary and overall relevance of the provided information on adverse effects on sexual function and fertility..................................................................................................................................................44 10.10.3 Comparison with the CLP criteria ........................................................................................................46 10.10.4 Conclusion on classification and labelling for adverse effects on sexual function and fertility ...........46 10.10.5 Adverse effects on development.............................................................................................................47 10.10.6 Short summary and overall relevance of the provided information on adverse effects on development 47 10.10.7 Comparison with the CLP criteria ........................................................................................................50 10.10.8 Adverse effects on or via lactation.........................................................................................................50 10.11 SPECIFIC TARGET ORGAN TOXICITY - SINGLE EXPOSURE..................................................................................51 10.11.1 Short summary and overall relevance of the provided information on specific target organ toxicity – single exposure .........................................................................................................................................................53 10.11.2 Comparison with the CLP criteria ........................................................................................................57 10.11.3 Conclusion on classification and labelling for STOT SE ......................................................................58 10.12 SPECIFIC TARGET ORGAN TOXICITY-REPEATED EXPOSURE ..............................................................................59 10.12.1 Short summary and overall relevance of the provided information on specific target organ toxicity – repeated exposure .....................................................................................................................................................65 10.12.2 Comparison