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Committee for Risk Assessment RAC Annex 1 Background Document to the Opinion Proposing Harmonised Classification and Labelling

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Committee for Risk Assessment RAC Annex 1 Background Document to the Opinion Proposing Harmonised Classification and Labelling Committee for Risk Assessment RAC Annex 1 Background document to the Opinion proposing harmonised classification and labelling at EU level of methyl acrylate; methyl propenoate EC Number: 202-500-6 CAS Number: 96-33-3 CLH-O-0000006956-59-01/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 18 March 2021 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 METHYL ACRYLATE CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: Methyl acrylate EC Number: 202-500-6 CAS Number: 96-33-3 Index Number: 607-034-00-0 Contact details for dossier submitter: Environment Agency Austria, Spittelauer Lände 5, A-1090 Vienna on behalf of the Austrian Competent Authority (Austrian Federal Ministry for sustainability and tourism, Stubenring 1, 1010 Vienna, Austria) Version number: 02 Date: January 2020 ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON METHYL ACRYLATE CONTENTS 1 IDENTITY OF THE SUBSTANCE ........................................................................................................... 1 1.1 NAME AND OTHER IDENTIFIERS OF THE SUBSTANCE .................................................................................. 1 1.2 COMPOSITION OF THE SUBSTANCE ............................................................................................................ 2 2 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ................................................ 4 2.1 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ACCORDING TO THE CLP CRITERIA ............... 4 3 HISTORY OF THE PREVIOUS CLASSIFICATION AND LABELLING .......................................... 7 4 JUSTIFICATION THAT ACTION IS NEEDED AT COMMUNITY LEVEL ..................................... 8 5 IDENTIFIED USES ..................................................................................................................................... 9 6 DATA SOURCES ........................................................................................................................................ 9 7 PHYSICOCHEMICAL PROPERTIES ................................................................................................... 10 8 EVALUATION OF PHYSICAL HAZARDS .......................................................................................... 11 9 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) 12 10 EVALUATION OF HEALTH HAZARDS .............................................................................................. 13 10.1 ACUTE TOXICITY - ORAL ROUTE ......................................................................................................... 13 10.1.1 Short summary and overall relevance of the provided information on acute oral toxicity ...... 15 10.1.2 Comparison with the CLP criteria ........................................................................................... 16 10.1.3 Conclusion on classification and labelling for acute oral toxicity ........................................... 16 10.2 ACUTE TOXICITY - DERMAL ROUTE .................................................................................................... 16 10.2.1 Short summary and overall relevance of the provided information on acute dermal toxicity.. 18 10.2.2 Comparison with the CLP criteria ........................................................................................... 18 10.2.3 Conclusion on classification and labelling for acute dermal toxicity ...................................... 18 10.3 ACUTE TOXICITY - INHALATION ROUTE .............................................................................................. 19 10.3.1 Short summary and overall relevance of the provided information on acute inhalation toxicity23 10.3.2 Comparison with the CLP criteria ........................................................................................... 24 10.3.3 Conclusion on classification and labelling for acute inhalation toxicity ................................. 24 10.4 SKIN CORROSION/IRRITATION ............................................................................................................. 25 10.5 SERIOUS EYE DAMAGE/EYE IRRITATION ............................................................................................. 30 10.6 RESPIRATORY SENSITISATION............................................................................................................. 30 10.7 SKIN SENSITISATION ........................................................................................................................... 30 10.8 GERM CELL MUTAGENICITY ............................................................................................................... 30 10.9 CARCINOGENICITY ............................................................................................................................. 30 10.10 REPRODUCTIVE TOXICITY................................................................................................................... 30 10.11 SPECIFIC TARGET ORGAN TOXICITY-SINGLE EXPOSURE ...................................................................... 30 ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON METHYL ACRYLATE 10.12 SPECIFIC TARGET ORGAN TOXICITY-REPEATED EXPOSURE ................................................................. 30 10.13 ASPIRATION HAZARD.......................................................................................................................... 30 11 EVALUATION OF ENVIRONMENTAL HAZARDS........................................................................... 31 12 EVALUATION OF ADDITIONAL HAZARDS ..................................................................................... 31 13 ADDITIONAL LABELLING ................................................................................................................... 31 14 ANNEXES................................................................................................................................................... 31 15 REFERENCES ........................................................................................................................................... 31 ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON METHYL ACRYLATE 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 international Methyl prop-2-enoate chemical name(s) Other names (usual name, trade name, abbreviation) 2-Propenoic acid methyl ester Propenoic acid methyl ester Methoxycarbonylethylene Acrylic acid methyl ester Methyl propenoate ISO common name (if available and appropriate) Not applicable EC number (if available and appropriate) 202-500-6 EC name (if available and appropriate) Methyl acrylate CAS number (if available) 96-33-3 Other identity code (if available) RTECS: AT2800000 ICSC Number: 0625 UN Number: 1919 PubChem CID: 7294 Molecular formula C4H6O2 Structural formula SMILES notation (if available) COC(=O)C=C Molecular weight or molecular weight range 86.09 g/mol Information on optical activity and typical ratio of (stereo) Not applicable isomers (if applicable and appropriate) Description of the manufacturing process and identity of the Not applicable source (for UVCB substances only) Degree of purity (%) (if relevant for the entry in Annex VI) ≥ 80 wt % 1 ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON METHYL ACRYLATE 1.2 Composition of the substance Methyl acrylate is a mono-constituent substance. Table 2: Constituents (non-confidential information). Constituent Concentration range Current CLH in Current self- (% w/w minimum and Annex VI Table 3.1 classification and (Name and numerical maximum in multi- (CLP) labelling (CLP) identifier) constituent substances) Methyl acrylate Not applicable Flam. Liq. 2 (H225) Flam. Liq. 2 (H225) EC 202-500-6 Acute Tox. 4 * (H302) Acute Tox. 4 (H302) CAS 96-33-3 Acute Tox. 4 * (H312) Acute Tox. 4 (H312) Acute Tox. 4 * (H332) Acute Tox. 3 (H331) Skin Irrit. 2 (H315) Skin Irrit. 2 (H315) Eye Irrit. 2 (H319) Eye Irrit. 2 (H319) Skin Sen. 1 (H317) Skin Sen. 1B (H317) STOT SE 3 (H335) STOT SE 3 (H335) Aquatic Chronic 3 (H412) Note D Table 3: Impurities (non-confidential information) if relevant for the classification of the substance. Impurity Concentration Current CLH in Current self- The impurity range Annex VI Table classification and contributes to the (Name and 3.1 (CLP) labelling (CLP) classification and numerical (% w/w minimum labelling identifier) and maximum) No data available Table 4: Additives (non-confidential information) if relevant for the classification of the substance. Additive Function Concentration Current CLH in Current self- The additive range Annex VI classification contributes to (Name and Table 3.1 and labelling the numerical (% w/w (CLP) (CLP) classification identifier) minimum and and labelling maximum) No relevant data on additives available.
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