Registration Dossier
Registration Dossier
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EC number: 605-104-5 | CAS number: 157577-99-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test: Positive
Ames test, similar substance 1: Positive
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test), similar substance 1: negative
OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test) similar substance 1: negative
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test), similar substance 1: negative
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay), similar substance 2: testing proposal
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
One Ames test is available on Acid Black 234 (ABK210 Consortium); the tes was performed on strain: TA98, TA100, TA1535, TA1537 and TA102 of Salmonella typhimurium, both in the absence and in the presence of a reductive hamster liver metabolising system (S-9).
Moreover, an Ames test is also available on similar substance 1 (Stahl, 1996). The test was performed on strain: TA100, TA 98, TA1535, TA 1537, WP2P and WP2PuvrA both in the absence and in the presence of a reductive liver metabolising system (S-9 mix).
Both test were disrgegarded for the reason discussed in the expert statement.
Therefore, one expert assessment was added as Weight of evidence, in order to analyse all the results of the Ames test, considering also the structural and mechanicistic evaluations.
One In vitro mammalian cell micronucleus test following OECD 487 (Consortium, 2010) and one gene mutation in vitro, following OECD 476 (Stahl, 1996) are available on similar substance 1 and both test show negative results.
Moreover, also an in vivo test, following OECD 474 is available on similar substance 1 (Stahl, 1996) and the results are negative.
Therefore the substance is consider not mutagenic for the time being.
In order to conclude the endpoint a testing proposal for a Comet assay has been proposed.
Short description of key information:
not mutagenic
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Classification for mutagenicity is warranted for substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans
The classification in Category 2 is based on:
— positive evidence obtained from experiments in mammals and/or in some cases
from in vitro experiments, obtained from:
— somatic cell mutagenicity tests in vivo, in mammals; or
— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Based on the negative results of the in vivo tests on the similar substance, OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) no classification for mutagenicity is applied following Regulation 1272/2008.
This classification will be confirmed after the results of the OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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