3-(chloromethyl)heptane

Endpoint summary

Additional information

In vitro:

In the key study, the test substance 2-Ethylhexylchloride was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay (BASF SE, 2012). The study was performed according to OECD guideline 471 in compliance with GLP. Test strains were S. typhimurium strains TA 1535, TA 100, TA 1537, and TA 98, as well as E. coli strain WP2 uvrA. A standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats) was performed. The substance was tested in the dose ranges 0.33 μg - 5300 μg/plate (SPT, TA Strains), 33 μg - 5300 μg/plate (SPT, E.coli), 0.33 μg - 100 μg/plate (PIT, TA Strains), and 33 μg - 5 300 μg/plate (PIT, E.coli).

No Precipitation of the test substance was found with and without S9 mix. A strong bacteriotoxic effect was observed depending on the

strain and test conditions from about 10 μg/plate onward. According to the results of the present study, the test substance did not lead to a biologically relevant increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in three experiments carried out independently of each other (standard plate test and preincubation assay). Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study.

Conclusion: Thus, under the experimental conditions of this study, the test substance 2-Ethylhexylchloride was not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

Supportingly, in another Ames test that was performed according to OECD guideline 471 in compliance with GLP using the tester strains S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the absence and presence of a metabolic activation system (Phenobarbital/-beta-Naphthoflavone co-induced rat liver S9 mix) the test item did not induce gene mutations by base pair changes or frame-shifts in the genome of the tester strains at doses up to 1000 µg/plate (Evonik, 2003).

Short description of key information:
Ames test in S. typhimurium strains TA 1535, TA 100, TA 1537, and TA 98, as well as E. coli strain WP2 uvrA in the absence and the presence of metabolic activation: negative (BASF SE, 2012).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available experimental test data concerning genetic toxicity are reliable but not sufficient for the purpose of classification under Directive 67/548/EEC (only an Ames test is available for assessment which was negative). Therefore, no classification is warranted concerning genetic toxicity due to lacking data.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data concerning genetic toxicity are reliable but not sufficient for the purpose of classification under Regulation (EC) No. 1272/2008 (only an Ames test is available for assessment which was negative). Therefore, no classification is warranted concerning genetic toxicity due to lacking data.