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Key value for chemical safety assessment

Additional information

A key study for reverse mutation in bacteria was performed in the Ames test with Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA (Shanks, 2007). The study was conducted according to internationally accepted testing and GLP guidelines. The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level and was therefore tested up to the maximum recommended dose level of 5000 µg/plate. An oily precipitate was observed at 5000 µg/plate, this did not prevent the scoring of revertant colonies. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.The test material was considered to be non-mutagenic under the conditions of this test.

A key cytogenetic assay was performed in human peripheral lymphocytes both with and without S9 fraction (Buskens, 2009).The study was conducted according to internationally accepted testing and GLP guidelines. In a first test, at exposure up to 150 µg/ml for a 3 h exposure time, precipitation occurred and appropriate toxicity was reached at this dose level in the absence of S9-mix. In a second test, the test material was tested up to 100 µg/ml for a 24 h exposure time and up to 70 µg/ml for a 48 h exposure time in the absence of S9-mix. In the presence of S9-mix testing went up to 150 µg/ml for a 3 h exposure time. There were no statistically significant or biologically relevant increases in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments.

A key mammalian cell gene mutation test was performed with L518Y mouse lymphoma cells (Verspeek-Rip, 2010).The study was conducted according to internationally accepted testing and GLP guidelines.In a first experiment, testing was performed up to concentrations of 100 µg/ml (+ S9-mix). The incubation time was 3 hours. In a second experiment, testing was performed up to 100 µg/ml, (+ S9-mix). The incubation times were 24 hours and 3 hours for incubations in the absence and presence of S9-mix, respectively. The test substance precipitated in the exposure medium at these dose levels. The spontaneous mutation frequencies in the solvent-treated control cultures were between the minimum and maximum value of the historical control data range and within the acceptability criteria of this assay. 2,2'-ethylenedioxydiethyl bis (2-ethylhexanoate) did not induce a significant increases in the mutation frequency both with and without S9, and both in the first and second experiment. In conclusion, the test material is not mutagenic in the TK mutation test system. 

These three independent studies are GLP-compliant guideline, which shall be used for assessment.

Short description of key information:
Gene mutation (Ames test); S. typhimurium TA98, TA100, TA1535, TA1537 and E. coli WP2uvrA-: Negative with and without metabolic activation (OECD 471).
Chromosome aberration; peripheral human lymphocytes: Negative (OECD 473).
Mammalian cell gene mutation; L5178Y mouse lymphoma cells: Negative (OECD 476).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

As all genotoxicity assays were negative, classification is not warranted.