Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

No reverse point mutation observed in a bacterial test system.

No clastogenic effects observed in human lymphocytes in vitro

No mutagenic effect observed in the mouse lymphoma assay in vitro.


Justification for selection of genetic toxicity endpoint
All 3 in vitro studies showed no effects.

Short description of key information:
Three in vitro key studies showed no mutagenic potential in the presence and absence of metabolic activation:
- an in vitro reverse mutation assay in S. typhimurium and E. coli (OECD 471)
- a chromosome aberration in human lymphocytes (OECD 473)
- a mouse lymphoma assay (OECD 476)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No mutagenic potential was detected in the 3 in vitro studies conducted according to current guidelines, in the presence or absence of metabolic potential.

Based on these data, there is currently no alert for mutagenic potential.