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Key value for chemical safety assessment

Additional information

IN VITRO

In a reverse gene mutation assay in bacteria (BASF SE, 2009), strains TA 98 and TA mix (i.e. TA7001, TA 7002, TA 7003, TA 7004, TA 7005 and TA 7006) of S. typhimurium were exposed to 2-Methyl-3,4-dibrombuttersäureethylester (ca. 98% pure) in DMSO at concentrations of 4, 20, 100, 500, 2500, and 5000 µg/ml in the presence and absence of mammalian metabolic activation (liquid suspension assay; Ames II Assay). The test was carried out according to a modified version of the Ames test (OECD 471), designated Ames II Assay (microtiter version).

2-Methyl-3,4-dibrombuttersäureethylester was tested up to limit concentrations. The positive controls induced the appropriate responses in the corresponding strains.

There was no evidence of induced mutant colonies over background.

This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.

IN VIVO

No data is available.


Short description of key information:
IN VITRO
Not mutagenic in bacteria (Ames II Assay) (BASF SE, 2009).
No classification / labeling required.

IN VIVO
No data is available.

Endpoint Conclusion:

Justification for classification or non-classification

There is no need to classify 2-Methyl-3,4-dibrombuttersäureethylester for mutagenicity according to the Directive 67/548/EC and according to the GHS criteria.

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