Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test, similar substance 2: Positive


Ames test NR, similar substance 2: nitroreductase activity, plays a major role in the mutagenic properties of the substance


OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test), similar substance 2: negative


 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test), similar substance 2: negative


OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo), similar substance 2: negative


OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay), similar substance 3: testing proposal


 

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

Additional information

Justification for classification or non-classification

Classification for mutagenicity 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.

Based on the negative results of the in vivo tests on the similar substance,
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) and OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)  no classification for mutagenicity is applied following Regulation 1272/2008.
This classification will be confirmed after the results of the OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay).