Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

An in vitro study key study was performed to investigate the potential of the test substance to induce gene mutations according to OECD Guideline 471 and EU Method B.14 in compliance with GLP. Under the study conditions, the test substance was considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.

A second key study was conducted with the test item according to OECD guideline no. 473 and in accordance with GLP.The test article was assessed for its potential toinduce structural chromosomal aberrations in V79 cells of the Chinese hamster in vitro. The substanceis considered to be non-mutagenic in this chromosome aberration test.

A third key study was conducted according to OECD guideline no. 476 and in accordance with GLP. In a mammalian cell gene mutation assay (HPRT locus), CHO cells cultured in vitro were exposed to the substance dissolved in culture medium at various concentrations. In the described in vitro cell gene mutagenicity test under the experimental conditions reported, the test item is considered to be mutagenic in the HPRT locus using CHO cells of the Chinese Hamster.

A testing proposal to perform an in vivo UDS assay according to OECD 486 guideline.


Justification for selection of genetic toxicity endpoint
All three studies were taken into consideration. The test substance showed negative results in the Salmonella typhimurium reverse mutation assay (OECD 471) and in an in vitro chromosome aberrations test (OECD 473). The substance showed positive results in the in vitro mammalian cell gene mutation assay (OECD 476).

Short description of key information:
The test substance showed negative results in the Salmonella typhimurium reverse mutation assay (OECD 471) and in the in vitro chromosome aberrations test (OECD 473) and Positive results in the in vitro in a mammalian cell gene mutation assay (OECD 476). The substance is therefore considered to have a mutagenic potential in vitro.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the above mentioned results the substance does not need to be classified according to CLP regulation (Regulation EC No.1272/2008).