Registration Dossier
Registration Dossier
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EC number: 274-402-1 | CAS number: 70210-05-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
One study (Clariant, 2005) has been chosen as key study for the genetic toxicity endpoint.
The test follows the OECD Test guideline 471 and in accordance to GLP principles and it was performed on Acid Violet 054.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the tested substance at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Therefore the substance is considered not mutagen.
Another study (Huntsman, 1994) is available for Acid Violet 054 and it was used as supporting.
The test follows the OECD Test guideline 471 and in accordance to GLP principles.
Also in this case the test article did not induce gene mutations.
Justification for selection of genetic toxicity endpoint
The study is performed in GLP and assesses the end point completely.
Short description of key information:
not mutagenic
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), for the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two categories in consideration of the fact that they are:
- substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans or
- substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.
The test substance did not show any reasons of concern in the test performed.
In conclusion, the substance is not classified for genetic toxicity according to the CLP Regulation (EC 1272/2008).
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