Registration Dossier
Registration Dossier
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EC number: 456-880-5 | CAS number: 439685-79-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) were exposed to Mexoryl SBF at concentrations up to 5000 µg/plate with and without S9 mix and using direct plate incorporation method and incubation method (2nd experiment with S9). Mexoryl SBF showed no substantial increases in revertant colony numbers over control count obtained with any of the tester strains at any concentrations in either presence or absence of S9 mix.
In an in vitro chromosome aberration test performed according to OECD Guideline 473 and in compliance with GLP, cultured human lymphocytes were exposed to Mexoryl SBF up to 10 mM. Test item did not induce a biologically relevant and statistically significant increase in the percentage of cells with structural chromosome aberrations at any of the concentrations, when compared with the vehicle control values.
In an in vitro mammalian cell gene mutation test performed according to OECD Guideline 476 and in compliance with GLP, mouse lymphoma L5178Y tk+/- (3.7.2C) cells were exposed to Mexoryl SBF dissolved in DMSO in RPMI 1640 medium for 3 h, with and without metabolic activation up to 10 mM. MEXORYL SBF showed no cytotoxicity effect and the mutant frequencies did not increase significantly compared to mean control mutant frequencies.
Short description of key information:
MEXORYL SBF was found not to be mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102, it did not induce chromosome aberrations in cultured human lymphocytes and it did not induce mutation at the tk locus of L5178Y mouse lymphoma cells.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
As MEXORYL SBF was negative in an in vitro reverse gene mutation assay in bacteria, in an in vitro chromosome aberration test and in an in vitro mammalian cell gene mutation test, it is not classified as mutagenic according to Annex VI to the Directive 67/548/EEC and in CLP Regulation (EC) N° (1272-2008).
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