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Glycidyl Methacrylate, GMA) CLH REPORT FOR 2,3-EPOXYPROPYL METHACRYLATE (GLYCIDYL METHACRYLATE) CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 Substance Name: 2,3-epoxypropyl methacrylate (Glycidyl methacrylate, GMA) EC Number: 203-441-9 CAS Number: 106-91-2 Index Number: 607-123-00-4 Contact details for dossier submitter: Bureau REACH National Institute for Public Health and the Environment (RIVM) The Netherlands [email protected] Version number: 2.0 Date: March 2015 1 CLH REPORT FOR 2,3-EPOXYPROPYL METHACRYLATE (GLYCIDYL METHACRYLATE) CONTENTS Part A. 1 PROPOSAL FOR HARMONISED CLASSIFICATION AND LABELLING ................................................. 5 1.1 SUBSTANCE ........................................................................................................................................................... 5 1.2 HARMONISED CLASSIFICATION AND LABELLING PROPOSAL .................................................................................. 5 1.3 PROPOSED HARMONISED CLASSIFICATION AND LABELLING BASED ON CLP REGULATION .................................... 7 1.4 HISTORY OF THE PREVIOUS CLASSIFICATION AND LABELLING ............................................................................ 11 1.5 SHORT SUMMARY OF THE SCIENTIFIC JUSTIFICATION FOR THE CLH PROPOSAL .................................................. 11 1.6 CURRENT HARMONISED CLASSIFICATION AND LABELLING .................................................................................. 14 1.6.1 Current classification and labelling in Annex VI, Table 3.1 in the CLP Regulation ................................ 14 1.7 CURRENT SELF-CLASSIFICATION AND LABELLING ............................................................................................... 15 1.7.1 Current self-classification and labelling based on the CLP Regulation criteria ...................................... 15 2 JUSTIFICATION THAT ACTION IS NEEDED AT COMMUNITY LEVEL .............................................. 15 Part B. SCIENTIFIC EVALUATION OF THE DATA ........................................................................................................... 16 1 IDENTITY OF THE SUBSTANCE .................................................................................................................... 16 1.1 NAME AND OTHER IDENTIFIERS OF THE SUBSTANCE ............................................................................................ 16 1.2 COMPOSITION OF THE SUBSTANCE ...................................................................................................................... 17 1.2.1 Composition of test material ..................................................................................................................... 17 1.3 PHYSICO-CHEMICAL PROPERTIES ........................................................................................................................ 22 2 MANUFACTURE AND USES ............................................................................................................................ 24 2.1 MANUFACTURE ................................................................................................................................................... 24 2.2 IDENTIFIED USES ................................................................................................................................................. 24 3 CLASSIFICATION FOR PHYSICO-CHEMICAL PROPERTIES ................................................................ 25 3.1 HAZARD CLASSES FOR PHYSICO-CHEMICAL PROPERTIES ......................................................................................... 25 3.1.1 Summary and discussion of classification for physico-chemical properties ............................................. 25 3.1.2 Comparison with criteria .......................................................................................................................... 25 3.1.3 Conclusions on classification and labelling ............................................................................................. 25 4 HUMAN HEALTH HAZARD ASSESSMENT .................................................................................................. 25 4.1 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ............................................. 25 4.1.1 Non-human information ............................................................................................................................ 25 4.1.2 Human information ................................................................................................................................... 31 4.1.3 Summary and discussion on toxicokinetics ............................................................................................... 31 4.2 ACUTE TOXICITY ................................................................................................................................................. 33 4.2.1 Non human information ......................................................................................................................................... 33 4.2.1.1 Acute toxicity: oral ................................................................................................................................................ 33 4.2.1.2 Acute toxicity: inhalation ....................................................................................................................................... 33 4.2.1.3 Acute toxicity: dermal ............................................................................................................................................ 35 The available information on the only available study is very limited and would normally not be usable for classification. However, there is already a harmonised minimum classification of GMA for acute dermal toxicity. It is likely that this study was the basis for the current harmonised classification. Therefore, this study can be used to adapt the current minimum classification. ......................................................................................................................................................... 36 4.2.1.4 Acute toxicity: other routes .................................................................................................................................... 36 4.2.2 Human information ................................................................................................................................... 36 4.2.3 Summary and discussion of acute toxicity ................................................................................................ 36 The available information on the only available acute dermal study is very limited and would normally not be usable for classification. However, there is already a harmonised minimum classification of GMA for acute dermal toxicity. It is 2 CLH REPORT FOR 2,3-EPOXYPROPYL METHACRYLATE (GLYCIDYL METHACRYLATE) likely that this study was the basis for the current harmonised classification. Therefore, this study can be used to adapt the current minimum classification. The dermal LD50 for rabbits in this study was 480 mg/kg bw (Smyth et al.: 1969). ......... 36 4.2.4 Comparison with criteria .......................................................................................................................... 37 4.2.5 Conclusions on classification and labelling ............................................................................................. 37 4.3 SPECIFIC TARGET ORGAN TOXICITY – SINGLE EXPOSURE (STOT SE).................................................................. 38 4.3.1 Summary and discussion of Specific target organ toxicity – single exposure ........................................... 38 4.3.2 Comparison with criteria .......................................................................................................................... 39 4.3.3 Conclusions on classification and labelling ............................................................................................. 40 4.4 IRRITATION ......................................................................................................................................................... 40 4.4.1 Skin irritation ............................................................................................................................................ 40 4.4.1.1 Non-human information ......................................................................................................................................... 40 4.4.1.2 Human information ................................................................................................................................................ 41 4.4.1.3 Summary and discussion of skin irritation ............................................................................................................. 41 4.4.1.4 Comparison with criteria ........................................................................................................................................ 43 4.4.1.5 Conclusions on classification and labelling ........................................................................................................... 43 4.4.2 Eye irritation ............................................................................................................................................. 43 4.4.2.1 Non-human information ........................................................................................................................................
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