Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

in vitro gene mutation in bacteria, OECD 471: positive

in vitro gene mutation in mammalian cells: waiving

in vitro cytogenicity in mammalian cells: waiving

Genetic toxicity in vivo

Description of key information

in vivo micronucleus OECD 474: negative

in vivo gene mutation, OECD 486: negative

in vivo gene mutation, OECD 489: TPE

Additional information

Justification for classification or non-classification

Classification for mutagenicity under Regulation 1272/2008 is warranted for substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans. The classification in Category 2 is based on:

— 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 test item is positive to the in vitro gene mutation in bacteria which triggers some tests at Annex IX level. A reliabale and adequate in vivo genetic toxicity test, OECD 486 UDS Assay, is available showing negative results that will be supported by the results of a testing proposal for a Comet Assay OECD 489 on the substance itself.

Also an in vivo micronucleus OECD 474 is available on the analogue substance showing negative results.

Based on the current available information, the substance is not considered mutagenic and a review of the classification will be performed once the OECD 489 results are available.

Categories Display