Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test was negative.

Micronucleous mutagenicity test (OECD 487): negative

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No information on "genetic toxicity" is available for the Target Substance. However data on a Similar Substance (Similar Substance 02) was taken into account for the assessment. No mutagenic effects were observed.

Justification for classification or non-classification

Bacterial reverse mutation assay, Ames test, showed negative results both with and without metabolic activation.
In vitro micronucleos genotoxicity test gave negative results.

Based on the test results it could be stated that no classification for mutagenicity is warranted under Regulation (CE) 1272/2008.