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Administrative data

Key value for chemical safety assessment

Additional information

None of the three in vitro mutagenicity studies in bacteria and mammalian cells afforded indications of mutagenic effects neither with nor without metabolic activation. No gene mutations nor chromosomal aberrations were detected.

The substance is regarded as not mutagenic.


Short description of key information:
There are 3 studies available:
Bacterial reverse mutation assay (Ames test) according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A with and without metabolic activation.
Dose range in all tests (with & without metabolic activation): 50 ... 5000 µg/plate

In vitro mammalian cell gene mutation (gene mutation) according to OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test) in a mammalian cell line (Mouse lymphoma L5178Y cells) with and without metabolic activation.
Doses: Concentration range in the main test 1 (with and without metabolic activation): 500 ... 4000 µg/ml
Concentration range in the main test 2 (with and without metabolic activation): 1000 ... 4000 µg/ml

In vitro mammalian chromosome aberration test according to OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test) in lymphocytes (human, primary culture) with and without metabolic activation.
Doses: Concentration range in the main test (with & without metabolic activation): 1250 ... 5000 µg/ml

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

None of the three in vitro mutagenicity studies in bacteria and mammalian cells afforded indications of mutagenic effects neither with nor without metabolic activation. No gene mutations nor chromosomal aberrations were detected.

The substance is

regarded as not mutagenic.