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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Results of available in vitro studies:

- AMES test: negative

- mammalian cell gene mutation test (HPRT-locus): negative.

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

Genetic toxicity in vivo

Description of key information

No study available.

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The genetic toxicity of Chlorphenesin was investigated with different types of in vitro tests.

- AMES test: the test item Chlorphenesin was examined in 2017 for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy till concentration 5000 μg/plate. The test was negative for all 5 strains (TA1535, TA1537, TA98, TA100 and WP2 uvrA) with and without metabolic activation. Similar results were obtained in other AMES tests performed before 2017.

- Structural and numerical chromosome aberrations: a negative chromosomal aberration test with human lymphocytes exposed in vitro to Chlorphenesin is reported in literature.

- HPRT: Chlorphensin was tested in 1987 for its ability to induce forward mutation at the functionally hemizygous hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro both in the presence and the absence of exogenous metabolic activation in the form of Aroclor 1254-induced rat liver S-9. Treatment of CHO cells with Chlorphensin up to its limit of toxicity (1500 µg/ml) induced dose-related cytotoxicity in all tests in the presence and absence of S-9 mix. Chlorphensin failed to induce a significant dose-related increase in mutant frequency in all tests in the presence and absence of S-9.

Justification for classification or non-classification

Chlorphenesin is not classified for genetic toxicity according to the CLP Regulation (EC.n.1272/2008). For justificationsee the results of available studies.

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