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Key value for chemical safety assessment

Additional information

The test substance 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 (OECD 471). The doses ranged form 10 μg - 5000 μg/plate (SPT) and 10 μg - 2500 μg/plate (PIT). No precipitation of the test substance was found with and without S9 mix. A bacteriotoxic effect was observed depending on the strain and test conditions from about 333 μg/plate onward. A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. The test substance not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation (BASF SE, 2016).

In further tests, the substance was also not capable to induce point mutations with or without metabolic activation (OECD TG 471, but only four strains tested). The doses ranged from 4 to 5000 μg/plate and bacteriotoxicity was noted at doses of 2500 μg/plate and above (BASF AG, 1986). In another Ames test the test substance was also negative up to 2832 μg/plate with and without using S9-mix (BASF AG, 1980).

The test compound was also negative in gene mutation test in mammalian cells in a HGPRT assay with Chinese hamster V79 cells (OECD TG 476). The cells were exposed to concentrations ranging from 0.03 to 1.2 mg/ml without metabolic activation and 0.1 to 2 mg/ml with metabolic activation. Higher concentrations could not be tested due to severe cytotoxic effects (BASF AG, 1992b).

Negative results were also obtained in the cytogenetic chromosome aberration assay with CHO (Chinese hamster ovary) cells according to OECD TG 473. The doses ranged from 78 to 313 μg/ml without and 156 to 625 μg/ml with metabolic activation. Cytotoxicity was observed at doses of 313 μg/ml without and 625 μg/ml with S9-mix (BASF AG, 1992c).

In conclusion, the substance showed no mutagenic and no cytogenetic effect in three different test systems in vitro. No in vivo data were available and in accordance with column 2 of REACH Annex VIII, these data are not needed as all in vitro studies are negative.

Short description of key information:
The substance showed no genotoxic effects in the Ames test (OECD TG 471), cytogenetic assay with CHO cells (OECD TG 473, GLP) and HGPRT assay (OECD TG 476, GLP) when tested up to the cyto/bacteriotoxic range.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, classification as a genotoxic substance is not triggered according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.