Registration Dossier
Registration Dossier
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EC number: 228-391-5 | CAS number: 6258-06-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Data on the genotoxicity of the test substance is available only as secondary source (ECB-IUCLID, 2000, Val. 4):
In Vitro
In an Ames assay, the S. typhimurium strains TA 1535, TA1537, TA 98 and TA100 were treated with the test substance. The test was conducted with and without metabolic activation. On S. typhimurium TA 100 and TA 98 a biologically relevant increase in the mutant count compared to the corresponding negative control was found. The positive response was found only with S9 mix. No further details were given (Bayer 17879, 1989).
In another Ames assay S. typhimurium strains TA 1535, TA1537, TA 1538, TA 98 and TA100 were treated with the test substance. The test was conducted with and without metabolic activation and revealed a negative result. No further details were given (Brown and Brown 1979).
An UDS assay was conducted in primary rat liver cells that revealed a negatve result. No further details were given (Bayer 20388, 1991).
In Vivo
In a micronucleus assay, which was conducted under GLP conditions, mice were treated once intraperitoneally with the test substance at concentrations of 20, 175, 350 and 700 mg/kw bw (Bayer 20898, 1991). No relevant indications of a clastogenic effect were found up to and including 700 mg/kg. No further details were given.
Short description of key information:
In vitro:
- Ames: positive in 2 of 4 tested strains with metabolic activation (TA98 and TA100; Bayer 17879, 1989).
- Ames: negative (Brown and Brown 1979)
- UDS: negative (Bayer 20388, 1991)
In vivo:
- Micronucleus assay: negative (Bayer 20898, 1991)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
Based on the available data of the test substance, classification for genetic toxicity under Directive 67/548/EEC is not warrented.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
Based on the available data of the test substance, classification for genetic toxicity under Regulation (EC) No. 1272/2008 is not warrented.
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