Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

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

Genetic toxicity in vivo

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

Additional information

Both in vitro and in vivo mutagenicity tests are available for analogue substance 4.

an ames test is in progress and expected negative.

The results of the in vitro mammalian cell gene mutation assay and the in vivo micronucleous assay, chromosome aberration test, made on the similar substance 2, are both negative.

In addiction also the in vivo micronucleus (bone marrow) test, made on analogue substance 4, following NTP guideline, showed negative results.

Based on these tests and the read across considerations same results apply to target substance

Short description of key information:

Not mutagenic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.

For the purpose of classification for germ cell mutagenicity, substances are classified if there is at least positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:

— somatic cell mutagenicity tests in vivo, in mammals; or

— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

The presented results from in vivo and the in vitro tests are negative, therefore it is concluded that target substance is not genotoxic with or without metabolic activation.