Registration Dossier
Registration Dossier
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EC number: 943-382-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro gene mutation, OECD 476, negative (similar substance 2)
in vitro bacteria test, OECD 471 with nitro-reductasi deficient strains: marked reduction in mutagenicity activity (similar substance 1)
Read across is attached in section 13
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
in vivo MNT, OECD 474: negative (on similar substance 2)
in vivo UDS, OECD 486: negative (on similar substance 2)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
For further details refer to the attached document on genotoxicity assessment
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 results of the in vivo and in vitro tests no classification for mutagenicity is applied following Regulation 1272/2008.
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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