Registration Dossier
Registration Dossier
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EC number: 605-150-6 | CAS number: 15848-49-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The Ames test (Sokolowski, 2011) performed according to OECD 471 (1997; GLP compliant) was rated with RL=2 (reliable with restrictions) and used as a key study. The study had a negative result. The results indicate that the test substance under the experimental conditions described, is not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and E. coli strain WP2 uvrA in the presence and absence of a metabolising system.
Furthermore, an in vitro mammalian cell micronucleus test (Bohnenberger, 2012) performed according to OECD 487 (2010; GLP compliant) was rated with RL = 1 (reliable without restrictions) and used as a key study. The study had a negative result. The results indicate that the test item did not induce micronuclei in human lymphocytes in vitro, when tested up to cytotoxic, the highest evaluable or the highest required concentrations.
Short description of key information:
in vitro studies:
Bacterial reverse mutation assay/Ames test (OECD 471; GLP compliant): negative
in vitro mammalian cell micronucleus test (OECD 487; GLP compliant): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The available reliable studies showed no genetic toxicity for Sultanene. Thus, no classification is required according to Regulation 1272/2008 and subsequent regulations.
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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