Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

in vitro bacteria mutagenicity with nitroreductasi deficient strains (modified OECD471): in progress

in vitro mammallian gene mutation (OECD 476): negative

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

in vivo UDS (OECD 486): negative

in vivo micronucleo (OECD 474): negative

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The read-across analogue substance is under investigation for in vitro bacteria mutagenicity follwoing a modified OECD 471 with nitroreductasi deficient strains. All other experiments using bacteria in vivo (host mediated assay), mammalian cells in vitro (CHO, hamster; HGPRT test), mammalian cells in a combined in vitro/in vivo study (UDS test) or whole animals (in vivo micronucleus test) the test substance did not exhibit any genetic activity.

Therefore, based on the information currently available, the substance does not meet the criteria for mutagenic effects classification under the Regulation EC 1272/2008 (CLP).