Registration Dossier
Registration Dossier
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EC number: 700-162-9 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In the in vitro chromosomal aberration test the ambiguous result after 21 hour exposure without metabolic activation is considered as artifactual result. Based on the very low water solubility of the test substance it is to be assumed that cells were not exposed to true solutions of the substance but to dispersions. It is known that exposure of cells to precipitates or dispersions, i.e. concentrated test substance, can lead to artifactual, false positive results.
In the in vivo micronucleus test in mice induction of chromosomal aberration was not detected up to and including the highest dose of 2000 mg/kg/day.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
There were no statistically significant increases in three in vitro and one in vivo genetic toxicity studies. Therefore, the attained results do not necessitate any labelling regarding mutagenicity according to EU classification rules [REGULATION (EC) 1272/2008].
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