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Administrative data

Key value for chemical safety assessment

Additional information

One key study investigating the bacterial gene mutation properties in bacteria of 2-(1-methylethoxy)ethyl acetate (CAS 19234-20-9) is available (Thompson, 2012). The study was conducted according to OECD guideline 471 under GLP conditions. The tester strains, Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 were investigated. The experiments of the main study were performed at concentrations from 50 to 5000 µg/plate in the first experiment according to the plate incorporation procedure and at 50 to 5000 µg/plate in the second experiment according to the pre-incubation procedure with and without a metabolic activation system (Aroclor 1254 -induced rat liver S9-mix). No cytotoxicity was observed up to the limit concentrations. No increase in the number of revertant colonies was observed in any of the bacterial strains, with and without metabolic activation system. The included positive and negative controls in the experiments showed the expected results and were therefore considered as valid. Under the conditions of this study, the test substance did not induce mutations in the bacterial mutation tests in the absence and presence of a metabolic activation system in any of the strains tested.

A single key study of mutagenicity in mammalian cells in-vitro is available, this conducted according OECD guideline 476 (Brown, 2013).The method used was designed to assess the potential mutagenicity of the substance on the thymidine kinase (TK +/-) locus of the L5178Y mouse lymphoma cell line. Two independent experiments were performed. In the first, cells were treated at six dose levels using 4-hours exposure both in the absence and presence of metabolic activation (S9). In the second experiment, the cells were treated at six dose levels for 4-hours exposure in the presence of metabolic activation (S9) and 24-hours exposure in the absence of metabolic activation. Concentrations ranging from 45.69 to 1462 μg/mL were investigated. The substance did not induce any toxicologically significant increases in the mutant frequency and is therefore considered to be non-mutagenic under the conditions of the test.

A single key study describing the results of an in vitro study for the detection of structural chromosomal aberrations in cultured mammalian cells is available (Morris, 2013). The study was conducted according to OECD guideline 473 under GLP conditions. Four treatment conditions were used for the study: in Experiment 1, 4 hours in the presence of an induced rat liver homogenate metabolizing system (S9), at a 2% final concentration with cell harvest after a 20-hour expression period and a 4 hours exposure in the absence of metabolic activation (S9) with a 20-hour expression period. In Experiment 2, the 4 hours exposure with addition of S9 was repeated (using a 1% final S9 concentration), whilst in the absence of metabolic activation the exposure time was increased to 24 hours. Concentrations of 45.69, 91.38, 182.75, 365.5, 731 and 1462 μg/mL were investigated and the three higher concentrations evaluated. The substance was non-toxic and did not induce any statistically significant increases in the frequency of cells with aberrations in either of two separate experiments

 

Conclusion for genetic toxicity

In-vitro studies with 2-(1-methylethoxy)ethyl acetate (CAS 19234-20-9) investigating the genetic mutation in bacteria and mammalian cells and cytogenicity in mammalian cells are available and provide negative results.


Justification for selection of genetic toxicity endpoint
No study was selected, since all available in vitro genetic toxicity studies were negative.

Short description of key information:
In vitro gene mutation in bacteria: negative with and without metabolic activation
In vitro cytogenicity in mammalian cells: negative with and without metabolic activation
In vitro gene mutation in mammalian cells: negative with and without metabolic activation

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification and labelling according to Regulation (EC) 1272/2008 or Directive 67/548/EEC of 2 -(1 -methylethoxy)ethyl acetate (CAS 19234-20-9) with respect to genetic toxicity is not justified on the basis of negative findings in 3 separate in-vitro tests for gene mutation/cytogenicity.