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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Non mutagenic in the Ames assay.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Mutagenic activity of test item was evaluated according to OECD guideline 471 in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and E. colu WP2 uvrA in presence and absence of metabolic activation by S9 -mix.

A preliminary solubility test and a preliminary range-finding test (using the plate incorporation method) were run.

In the initial mutation test (plate incorporation method), test concentrations were:

-S9: 120, 80, 50, 16, 5, 1.6, 0.5 µg/plate;

+S9: 500, 160, 50, 16, 5, 1.6, 0.5 µg/plate.

In the confirmatory mutation test (plate incubation method), test concentrations were based on the palte incorporation test results and wer as follows:

-S9: 50, 16, 5, 1.6, 0.5, 0.16, 0.05 µg/plate;

+S9: 320, 160, 50, 16, 5, 1.6, 0.5 µg/plate.

No precipitation was seen in any concentration level.

Cytotoxicity was seen in all tester strains.

Positive and negative controls were valid.

No biologically relevant increases were observed in revertant colony numbers of any of the five test strains following treatment with test item at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments. Therefore, the item is considered not mutagenic in this assay.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), classification in:

-category 1 for germ cell mutagens applies to substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans.

- category 1A: is based on positive evidence from human epidemiological studies. Substances to be regarded as if they induce heritable mutations in the germ cells of humans.

- category 1B: is based on:

- positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or

 - positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells. It is possible to derive this supporting evidence from mutagenicity/genotoxicity tests in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells; or - positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.

- category 2: substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans, based on:

 - positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:

 - somatic cell mutagenicity tests in vivo, in mammals; or

 - other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays. Note: Substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, shall be considered for classification as category 2 mutagens.

Based on the result in bacteria cells, test item is considered as devoid of a genotoxic potential and is not classified within the CLP Regulation (EC 1272/2008).