Committee for Risk Assessment RAC Annex 1 Background document to the Opinion proposing harmonised classification and labelling at EU level of divanadium pentaoxide; vanadium pentoxide EC Number: 215-239-8 CAS Number: 1314-62-1 CLH-O-0000006927-60-01/F The background document is a compilation of information considered relevant by the dossier submitter or by RAC for the proposed classification. It includes the proposal of the dossier submitter and the conclusion of RAC. It is based on the official CLH report submitted to public consultation. RAC has not changed the text of this CLH report but inserted text which is specifically marked as ‘RAC evaluation’. Only the RAC text reflects the view of RAC. Adopted 10 December 2020 P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu [04.01-ML-009.02] ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON DIVANADIUM PENTAOXIDE; VANADIUM PENTOXIDE ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON DIVANADIUM PENTAOXIDE; VANADIUM PENTOXIDE CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: Divanadium pentaoxide EC Number: 215-239-8 CAS Number: 1314-62-1 Index Number: 023-001-00-8 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: August 2019 3 ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON DIVANADIUM PENTAOXIDE; VANADIUM PENTOXIDE CONTENTS 1 IDENTITY OF THE SUBSTANCE ....................................................................................................................... 6 1.1 NAME AND OTHER IDENTIFIERS OF THE SUBSTANCE .............................................................................................. 6 1.2 COMPOSITION OF THE SUBSTANCE ......................................................................................................................... 7 2 SEE SPECIFIC STUDY RECORDS BELOW FOR FURTHER INFORMATION.PROPOSED HARMONISED CLASSIFICATION AND LABELLING .......................................................................................... 10 2.1 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ACCORDING TO THE CLP CRITERIA .......................... 10 3 HISTORY OF THE PREVIOUS CLASSIFICATION AND LABELLING .................................................... 12 4 JUSTIFICATION THAT ACTION IS NEEDED AT COMMUNITY LEVEL ............................................... 12 5 IDENTIFIED USES ............................................................................................................................................... 12 6 DATA SOURCES .................................................................................................................................................. 12 7 PHYSICOCHEMICAL PROPERTIES............................................................................................................... 15 8 EVALUATION OF PHYSICAL HAZARDS ...................................................................................................... 16 9 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ............ 17 9.1 SHORT SUMMARY AND OVERALL RELEVANCE OF THE PROVIDED TOXICOKINETIC INFORMATION ON THE PROPOSED CLASSIFICATION(S) ....................................................................................................................................... 18 10 EVALUATION OF HEALTH HAZARDS ......................................................................................................... 22 10.1 ACUTE TOXICITY - ORAL ROUTE ...................................................................................................................... 22 10.1.1 Short summary and overall relevance of the provided information on acute oral toxicity ................... 24 10.1.2 Comparison with the CLP criteria ........................................................................................................ 25 10.1.3 Conclusion on classification and labelling for acute oral toxicity ....................................................... 25 10.2 ACUTE TOXICITY - DERMAL ROUTE ................................................................................................................. 25 10.2.1 Short summary and overall relevance of the provided information on acute dermal toxicity .............. 26 10.2.2 Comparison with the CLP criteria ........................................................................................................ 26 10.2.3 Conclusion on classification and labelling for acute dermal toxicity ................................................... 26 10.3 ACUTE TOXICITY - INHALATION ROUTE ........................................................................................................... 27 10.3.1 Short summary and overall relevance of the provided information on acute inhalation toxicity ......... 29 10.3.2 Comparison with the CLP criteria ........................................................................................................ 30 10.3.3 Conclusion on classification and labelling for acute inhalation toxicity .............................................. 30 10.4 SKIN CORROSION/IRRITATION ......................................................................................................................... 43 10.5 SERIOUS EYE DAMAGE/EYE IRRITATION .......................................................................................................... 43 10.6 RESPIRATORY SENSITISATION ......................................................................................................................... 44 10.6.1 Comparison with the CLP criteria ........................................................................................................ 49 10.6.2 Conclusion on classification and labelling for respiratory sensitisation .............................................. 49 10.7 SKIN SENSITISATION ........................................................................................................................................ 53 10.8 GERM CELL MUTAGENICITY ............................................................................................................................ 53 10.8.1 Short summary and overall relevance of the provided information on germ cell mutagenicity ........... 64 10.8.2 Comparison with the CLP criteria ........................................................................................................ 66 10.8.3 Conclusion on classification and labelling for germ cell mutagenicity ................................................ 68 10.9 CARCINOGENICITY .......................................................................................................................................... 76 10.9.1 Short summary and overall relevance of the provided information on carcinogenicity ....................... 81 10.9.2 Comparison with the CLP criteria ........................................................................................................ 85 10.9.3 Conclusion on classification and labelling for carcinogenicity ............................................................ 87 10.10 REPRODUCTIVE TOXICITY ............................................................................................................................... 95 4 ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON DIVANADIUM PENTAOXIDE; VANADIUM PENTOXIDE 10.10.1 Adverse effects on sexual function and fertility..................................................................................... 95 10.10.2 Short summary and overall relevance of the provided information on adverse effects on sexual function and fertility ............................................................................................................................................... 103 10.10.3 Comparison with the CLP criteria ...................................................................................................... 107 10.10.4 Adverse effects on development .......................................................................................................... 109 10.10.5 Short summary and overall relevance of the provided information on adverse effects on development 117 10.10.6 Comparison with the CLP criteria ...................................................................................................... 119 10.10.7 Adverse effects on or via lactation ...................................................................................................... 122 10.10.8 Short summary and overall relevance of the provided information on effects on or via lactation ..... 126 10.10.9 Comparison with the CLP criteria ...................................................................................................... 128 10.10.10 Conclusion on classification and labelling for reproductive toxicity ................................................. 130 10.11 SPECIFIC TARGET ORGAN TOXICITY-SINGLE EXPOSURE ................................................................................. 151 10.12 SPECIFIC TARGET ORGAN TOXICITY-REPEATED EXPOSURE ............................................................................ 151 10.12.1 Short summary and overall relevance of the provided information on specific target organ toxicity – repeated exposure .................................................................................................................................................