Registration Dossier
Registration Dossier
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EC number: 949-711-6 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to Regulation (EC) No 1907/2006, Annex IX, 8.4, column 2, if there is a positive result in any of the in vitro genotoxicity studies in Annex VII or VIII and there are no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study shall be proposed by the registrant.
Based on the negative results obtained in all three in vitro genotoxicity studies from Annex VII or VIII with the target substance Saccharomyces cerevisiae cell wall, extracted (ref studies 471 and 487 to be added once performed and study reports available) or on its structurally related analogue Saccharomyces cerevisiae, lysate (Sire, Klimisch 1, GLP, 2018, OECD TG 490), an in vivo somatic cell genotoxicity study need not to be proposed.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
