CLH REPORT FOR 2-(2-METHOXYETHOXY)ETHANOL 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-methoxyethoxy)ethanol; diethylene glycol monomethyl ether EC Number: 203-906-6 CAS Number: 111-77-3 Index Number: 603-107-00-6 Contact details for dossier submitter: RIVM, The Netherlands National Institute for Public Health and the Environment Centre for Safety of Substances and Products Bilthoven, The Netherlands Version number: 2.0 Date: 2019-04-04 [04.01-MF-003.01] CLH REPORT FOR 2-(2-METHOXYETHOXY)ETHANOL 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 ........................................................... 3 2.1 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ACCORDING TO THE CLP CRITERIA ........................... 3 3 HISTORY OF THE PREVIOUS CLASSIFICATION AND LABELLING ..................................................... 5 4 JUSTIFICATION THAT ACTION IS NEEDED AT COMMUNITY LEVEL ................................................ 5 5 IDENTIFIED USES ................................................................................................................................................ 5 6 DATA SOURCES.................................................................................................................................................... 5 7 PHYSICOCHEMICAL PROPERTIES ................................................................................................................ 6 8 EVALUATION OF PHYSICAL HAZARDS ....................................................................................................... 6 9 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ............. 7 9.1 SUMMARY AND OVERALL RELEVANCE OF THE PROVIDED TOXICOKINETIC INFORMATION ON THE PROPOSED CLASSIFICATION(S) ......................................................................................................................................................... 8 10 EVALUATION OF HEALTH HAZARDS ......................................................................................................... 11 10.1 ACUTE TOXICITY ............................................................................................................................................ 11 10.2 SKIN CORROSION/IRRITATION ......................................................................................................................... 11 10.3 SERIOUS EYE DAMAGE/EYE IRRITATION ......................................................................................................... 11 10.4 RESPIRATORY SENSITISATION......................................................................................................................... 11 10.5 SKIN SENSITISATION ....................................................................................................................................... 11 10.6 GERM CELL MUTAGENICITY ........................................................................................................................... 11 10.7 CARCINOGENICITY ......................................................................................................................................... 11 10.8 REPRODUCTIVE TOXICITY............................................................................................................................... 12 10.8.1 Adverse effects on sexual function and fertility .................................................................................... 12 10.8.2 Summary and overall relevance of the animal studies on adverse effects on sexual function and fertility 13 10.8.3 Human data .......................................................................................................................................... 14 10.8.4 Other relevant data .............................................................................................................................. 14 10.8.5 Short summary and overall relevance of the provided information on adverse effects on sexual function and fertility ................................................................................................................................................ 14 10.8.6 Comparison with the CLP criteria ....................................................................................................... 15 10.8.7 Developmental effects .......................................................................................................................... 15 10.8.8 Summary and overall relevance of the provided animal studies on adverse effects on development .. 17 10.8.9 Human data .......................................................................................................................................... 19 10.8.10 Other relevant information .................................................................................................................. 19 10.8.11 Short summary and overall relevance of the provided information on adverse effects on development 19 10.8.12 Comparison with the CLP criteria ....................................................................................................... 20 10.8.13 Adverse effects on or via lactation ....................................................................................................... 22 10.8.14 Animal data .......................................................................................................................................... 22 10.8.15 Human data .......................................................................................................................................... 22 10.8.16 Short summary and overall relevance of the provided information on effects on or via lactation ...... 22 10.8.17 Comparison with the CLP criteria ....................................................................................................... 22 10.8.18 Conclusion on classification and labelling for reproductive toxicity ................................................... 22 10.9 SPECIFIC TARGET ORGAN TOXICITY-SINGLE EXPOSURE .................................................................................. 22 10.10 SPECIFIC TARGET ORGAN TOXICITY-REPEATED EXPOSURE ............................................................................. 22 11 EVALUATION OF ENVIRONMENTAL HAZARDS ...................................................................................... 22 [04.01-MF-003.01] CLH REPORT FOR 2-(2-METHOXYETHOXY)ETHANOL 12 REFERENCES ...................................................................................................................................................... 23 13 ANNEXES .............................................................................................................................................................. 24 13.1 ANNEX 1, STUDY SUMMARIES ...................................................................................................................... 24 13.1.1 Summary of the developmental toxicity study by Hardin et al. (1986) ................................................. 24 13.1.1.1 Introduction and overview study design (methods & endpoints) ...................................................................... 25 13.1.1.2 Results .............................................................................................................................................................. 25 13.1.1.3 Discussion & Summary .................................................................................................................................... 32 13.1.2 Summary of the developmental toxicity study by Yamano et al. (1993) ............................................... 33 13.1.2.1 Introduction and overview study design (methods & endpoints) ...................................................................... 33 13.1.2.2 Results .............................................................................................................................................................. 34 13.1.2.1 Discussion & Summary .................................................................................................................................... 42 13.2 ANNEX 2, SUMMARY OF REPRODUCTIVE TOXICITY PROFILE OF 2-METHOXYACETIC ACID ............................ 43 13.2.1 Introduction .......................................................................................................................................... 43 13.2.2 Effects on fertility and development ..................................................................................................... 43 13.2.3 Conclusions and relation of effects caused by MAA and DEGME ...................................................... 44 [04.01-MF-003.01] CLH REPORT FOR 2-(2-METHOXYETHOXY)ETHANOL 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