Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The substance was not mutagenic in two Ames tests according to OECD TG 471 with Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98, and TA 102, when tested without and with metabolic activation in the plate incorporation as well as in the preincubation method.

Biologically relevant and statistically significant genotoxic potential was concluded from a gene mutation test with mammalian cells (HPRT) according to OECD TG 476 and from two in vitro chromosome aberration tests according to OECD TG 473. In these assays a significant concentration-related cytotoxicity was also revealed for the substance.

To clarify the relevance of the positive findings in the in vitro assays two in vivo genotoxicity tests were conducted. This approach is in line with common testing strategies including the Integrated Testing Strategy (ITS) for mutagenicity as outlined in Guidance Document R.7a (ECHA, 2014, chapter 7.7.6). Based on the ITS an in vivo micronucleus assay according to OECD TG 474 was performed to cover chromosome aberration and a rat liver UDS assay according to OECD TG 486 was performed as a surrogate for an in vivo gene mutation test. Aerosol inhalation up to the maximum tolerated concentration was chosen as route of exposure based on exposure considerations as well as taking into account the toxicological profile of the substance as well as the class of compounds under evaluation. Both studies revealed no indication of genotoxicity under in vivo conditions. Therefore the effects observed in vitro were not confirmed in vivo.

Overall, it is assumed that in vivo genotoxicity is not an endpoint of concern for the substance.

Justification for selection of genetic toxicity endpoint
No study selected since all available studies (in vitro, in vivo) are relevant for the assessment of genetic toxicity for the substance.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I, no classifcation is warranted for genetic toxicity.