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Key value for chemical safety assessment

Additional information

In vitro data

Mutagenicity in bacterial reverse mutation assays (Ames test) has been investigated in three tests. Negative results were obtained in all tests with and without metabolic activation. Test on Escherichia Coli is running and the result is expected by the end of July 2014

Clastogenicity in mammalian cells has been investigated in reliable studies with CAS 16090 -02 -1 (according to OECD TG 473). Negative results were obtained in the presence and absence of metabolic activation.

Mammalian mutagenicity test according to OECD 476 (HPRT) is in progress, therefore the results are not yet available. Nevertheless, at the present all the available data indicate that the substance has not mutagenic or genotoxicological properties; it it expected that the assessment in course will confirm these outcomes.

In vivo data

Induction of micronuclei in vivo was investigated in three reliable tests with mice which were orally treated with CAS 16090-02-1 at doses up to 5000 mg/kb bw. No increase in the number of micronuclei was observed. No toxic effects were observed. Induction of chromosome aberration in vivo was investigated in two reliable tests with chinese hamsters which were orally treated with CAS 16090 -02 -1 and 13863-31-5 at doses up to 5000 mg/kg bw. Both tests showed absence of clastogenic effects. No toxic effects were observed.

Justification for selection of genetic toxicity endpoint
Conclusion on the endpoint has been drawn integrating the evaluation of the following studies: Ames test (Ciba Geigy 1991), in vitro gene mutation on mammalian cells (Research Institute for Organic Syntheses Inc. CETA. 2014), in vitro chromosomal aberration (Ciba geigy 1991).
The HPRT test is in progress, therefore the results are not yet available. Nevertheless, at the present all the available data indicate that the substance has not mutagenic or genotoxicological properties; it it expected that the assessment in course will confirm these outcomes.

Short description of key information:
Ames test (OECD Guideline 471 (Bacterial Reverse Mutation Assay)) = negative with and without metabolic activation
In vitro chromosomal aberration (OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test)) = negative with and without metabolic activation
In vivo chromosomal aberration (OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)) = negative and no toxic effects observed
Mammalian mutagenicity test according to OECD 476 (HPRT) is in progress, therefore the results are not yet available.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.5 Germ cell mutagenicity section, a mutation means a permanent change in the amount or structure of the genetic material in a cell. The term ‘mutation’ applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known (including specific base pair changes and chromosomal trans locations). The term ‘mutagenic’ and ‘mutagen’ will be used for agents giving rise to an increased occurrence of mutations in population of cells and/or organisms.

The more general terms ‘genotoxic’ and ‘genotoxicity’ apply to agents or processes which alter the structure, information content, or segregation of DNA, including those which cause DNA damage by interfering with normal replication processes, or which in a non- physiological manner (temporarily) alter its replication. Genotoxicity test results are usually taken as indicators for mutagenic effects.

For the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two categories in consideration of the fact that they are:

- substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans or

- substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

The test substance did not show any reasons of concern in the test performed.

In conclusion, the available experimental data are adequate for classification and labelling and the substance is not classified for genetic toxicity according to the CLP Regulation (EC 1272/2008).