Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

All available in vitro tests in genetic toxicity (GLP compliant and scored Klimisch 1 and 2) showed negative results. Thus there is no need to carry out in vivo studies in genetic toxicity.

Justification for selection of genetic toxicity endpoint
No specific study was selected because all available in vitro studies were negative. Conclusions are based on the following assays: Bacterial reverse mutation assay (Ames test); Mammalian cell gene mutation assay; In vitro micronucleous test.

Short description of key information:
There are'nt any available studies on humans for this endpoint. There are four in vitro studies availble.

The results of in vitro studies are negative, both with and without metabolic activation:

- Two Ames test with S. typhimurium TA 98, TA 100, TA102, TA 1535 and TA 1537 (met. act.: with and without) (OECD TG 471 and GLP compliant); no toxicity was observed.

- Mammalian cell gene mutation assay at the Thymidine Kinase Locus (TK) in Mouse Lynphoma L5178Y cells (met. act.: with and without) (OECD Guideline 476 and GLP); cytotoxicity: preliminary toxicity tests didn't show cytotoxicity, toxicity was detected at 6000 µg/mL in the second experiment after 24 hour of exposure with metabolic activation. The experiments resulted on negative results (no adverse effect observed).

- In vitro Micronoucleous Test in Chinese Hamster V79 cells (met. act.: with and without) (OECD Guideline 487 and GLP): preliminary toxicity tests showed citotoxicity at 1470.5 µg/mL and above. The result of the study is that the substance is considered to be non-mutagenic in this in vitro test system, when tested up to the highest evaluable and/or precipitating concentrations.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Following the criteria as described in Directive 67/548/EEC and Annex 1of Regulation (EC) No. 1272/2008, and based on the available data, the substance is not classified for genetic toxicity