CLH REPORT FOR 2,2-BIS(BROMOMETHYL)PROPANE-1,3-DIOL CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: 2,2-bis(bromomethyl)propane-1,3-diol EC Number: 221-967-7 CAS Number: 3296-90-0 Index Number: - Contact details for dossier submitter: Norwegian Environment Agency PB 5672 Sluppen, N-7485 Trondheim Norway Version number: 1.2 Date: 07.04.2017 CLH REPORT FOR 2,2-BIS(BROMOMETHYL)PROPANE-1,3-DIOL 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 ............................................... 3 2.1 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ACCORDING TO THE CLP CRITERIA................ 3 3 HISTORY OF THE PREVIOUS CLASSIFICATION AND LABELLING.......................................... 4 4 JUSTIFICATION THAT ACTION IS NEEDED AT COMMUNITY LEVEL .................................... 5 5 IDENTIFIED USES .................................................................................................................................... 5 6 DATA SOURCES........................................................................................................................................ 5 7 PHYSICOCHEMICAL PROPERTIES .................................................................................................... 5 8 EVALUATION OF PHYSICAL HAZARDS............................................................................................ 6 9 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION).. 6 9.1 SHORT SUMMARY AND OVERALL RELEVANCE OF THE PROVIDED TOXICOKINETIC INFORMATION ON THE PROPOSED CLASSIFICATION(S) .......................................................................................................................... 10 10 EVALUATION OF HEALTH HAZARDS ............................................................................................. 10 10.1 SKIN CORROSION/IRRITATION ............................................................................................................. 11 10.2 SERIOUS EYE DAMAGE/EYE IRRITATION.............................................................................................. 11 10.3 RESPIRATORY SENSITISATION ............................................................................................................. 11 10.4 SKIN SENSITISATION ........................................................................................................................... 11 10.5 GERM CELL MUTAGENICITY................................................................................................................ 11 10.5.1 Short summary and overall relevance of the provided information on germ cell mutagenicity19 10.5.2 Comparison with the CLP criteria ........................................................................................... 20 10.5.3 Conclusion on classification and labelling for germ cell mutagenicity.................................... 21 10.6 CARCINOGENICITY.............................................................................................................................. 21 10.6.1 Short summary and overall relevance of the provided information on carcinogenicity........... 26 10.6.2 Comparison with the CLP criteria ........................................................................................... 29 10.6.3 Conclusion on classification and labelling for carcinogenicity ............................................... 30 10.7 SPECIFIC TARGET ORGAN TOXICITY-SINGLE EXPOSURE ...................................................................... 30 10.8 SPECIFIC TARGET ORGAN TOXICITY-REPEATED EXPOSURE ................................................................. 30 10.9 ASPIRATION HAZARD .......................................................................................................................... 30 11 EVALUATION OF ENVIRONMENTAL HAZARDS.......................................................................... 30 12 EVALUATION OF ADDITIONAL HAZARDS .................................................................................... 30 13 ADDITIONAL LABELLING................................................................................................................... 30 14 REFERENCES .......................................................................................................................................... 31 15 ANNEXES.................................................................................................................................................. 31 CLH REPORT FOR 2,2-BIS(BROMOMETHYL)PROPANE-1,3-DIOL 1 IDENTITY OF THE SUBSTANCE 1.1 Name and other identifiers of the substance Table 1: Substance identity and information related to molecular and structural formula of the substance Name(s) in the IUPAC nomenclature or other 2,2-bis(bromomethyl)propane-1,3-diol international chemical name(s) Other names (usual name, trade name, abbreviation) BMP ISO common name (if available and appropriate) EC number (if available and appropriate) 221-967-7 EC name (if available and appropriate) 2,2-bis(bromomethyl)propane-1,3-diol CAS number (if available) 3296-90-0 Other identity code (if available) Molecular formula C5H10Br2O2 Structural formula SMILES notation (if available) C(CO)(CO)(CBr)CBr Molecular weight or molecular weight range 261.94 Information on optical activity and typical ratio of (stereo) isomers (if applicable and appropriate) Description of the manufacturing process and identity of the source (for UVCB substances only) Degree of purity (%) (if relevant for the entry in Annex ≥ 98.5 % VI) 1.2 Composition of the substance Table 2: Constituents (non-confidential information) - 1 CLH REPORT FOR 2,2-BIS(BROMOMETHYL)PROPANE-1,3-DIOL Table 3: Impurities (non-confidential information) if relevant for the classification of the substance Impurity Concentration Current CLH in Current self- The impurity (Name and range Annex VI Table 3.1 classification and contributes to the numerical (% w/w minimum (CLP) labelling (CLP) classification and identifier) and maximum) labelling - Table 4: Additives (non-confidential information) if relevant for the classification of the substance - 2 CLH REPORT FOR 2,2-BIS(BROMOMETHYL)PROPANE-1,3-DIOL 2 PROPOSED HARMONISED CLASSIFICATION AND LABELLING 2.1 Proposed harmonised classification and labelling according to the CLP criteria Table 5: Classification Labelling International Specific Pictogram, Suppl. Index No Chemical EC No CAS No Hazard Class Hazard Hazard Conc. Limits, Notes Signal Hazard Identification and Category statement statement M-factors Word statement Code(s) Code(s) Code(s) Code(s) Code(s) Current Annex VI - entry 2,2- Dossier 221-967- 3296-90- Muta. 1B H340 GHS08 H340 submitters bis(bromomethyl) 7 0 Dgr proposal propane-1,3-diol Carc. 1B H350 H350 Resulting Annex VI 2,2- 221-967- 3296-90- Muta. 1B H340 GHS08 H340 entry if bis(bromomethyl) agreed by 7 0 Carc. 1B H350 Dgr H350 RAC and propane-1,3-diol COM 3 CLH REPORT FOR 2,2-BIS(BROMOMETHYL)PROPANE-1,3-DIOL Table 6: Reason for not proposing harmonised classification and status under public consultation Within the scope of public Hazard class Reason for no classification consultation Explosives Hazard class not assessed in this dossier No Flammable gases (including Hazard class not assessed in this dossier No chemically unstable gases) Oxidising gases Hazard class not assessed in this dossier No Gases under pressure Hazard class not assessed in this dossier No Flammable liquids Hazard class not assessed in this dossier No Flammable solids Hazard class not assessed in this dossier No Self-reactive substances Hazard class not assessed in this dossier No Pyrophoric liquids Hazard class not assessed in this dossier No Pyrophoric solids Hazard class not assessed in this dossier No Self-heating substances Hazard class not assessed in this dossier No Substances which in contact with water emit flammable Hazard class not assessed in this dossier No gases Oxidising liquids Hazard class not assessed in this dossier No Oxidising solids Hazard class not assessed in this dossier No Organic peroxides Hazard class not assessed in this dossier No Corrosive to metals Hazard class not assessed in this dossier No Acute toxicity via oral route Hazard class not assessed in this dossier No Acute toxicity via dermal route Hazard class not assessed in this dossier No Acute toxicity via inhalation Hazard class not assessed in this dossier No route Skin corrosion/irritation Hazard class not assessed in this dossier No Serious eye damage/eye Hazard class not assessed in this dossier No irritation Respiratory sensitisation Hazard class not assessed in this dossier No Skin sensitisation Hazard class not assessed in this dossier No Germ cell mutagenicity Harmonised classification proposed Yes Carcinogenicity Harmonised classification proposed Yes Reproductive toxicity Hazard class not assessed in this dossier No Specific target organ toxicity- Hazard class not assessed in this dossier No single exposure Specific target organ toxicity- Hazard class not assessed in this dossier No