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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In a reliable and GLP guideline study, the substance showed no evidence of mutagenicity in a bacterial reverse mutation (Ames) assay in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli strain WP2uvra, with or without metabolic activation.

In a guideline and GLP in vitro chromosome abberation study using human blood lymphocytes, the substance did not induce chromosomal aberrations in human lymphocytes with our without metabolic activation.

In a guideline and GLP HPRT mammalian cell gene mutation assay using Chinese Hamster lung fibroblasts, the substance was unable to induce gene mutations and therefore considered negative in the assay.

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

Genetic toxicity in vivo

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

Additional information

Justification for classification or non-classification

From the available data on the substance, there is no indication of the substance having genotoxic or mutagenic properties, therefore classification is not warranted.

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