Registration Dossier
Registration Dossier
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EC number: 432-840-2 | CAS number: 220926-97-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In a reverse gene mutation assay in bacteria, histidine dependent auxotrophic mutants of S. typhimurium (strains TA 1535, TA 1537, TA 100 et TA 98) and a tryptophan dependent mutant of E. Coli (WP2uvrA/pKM101) were exposed to E96095 diluted in purified water with 0.15 % agar added to assist suspension in the presence and absence of liver preparations from Aroclor 1254-induced rats (S9 mix). A first experiment was a standard plate incorporation assay at 7 concentrations up to 5000 µg/plate. A second experiment involved a pre-incubation stage with 5 concentrations tested. There was no evidence of induced mutant colonies over background in this study.
In an in vitro chromosome aberration test performed according to OECD guideline No 473 and in compliance with GLP, E96095 showed no
evidence of chromosome aberration induced over background in human primary lymphocyte cultures exposed to up to 5000 µg/mL with and without metabolic activation.
In a mouse lymphoma assay performed according to OECD guideline No 476 and in compliance with GLP, E96095 showed no
increase in cell mutants up to the precipitation 160 µg/mL test concentration with and without metabolic activation.
Under the test conditions, E96095 is not mutagenic and clastogenic in vitro.
Justification for selection of genetic toxicity endpoint
None selected, all in vitro assays were negative
Short description of key information:
In a reverse gene mutation assay in bacteria performed according to OECD guideline No 471 and in compliance with GLP, E96095 induced no increase of revertants in any strains at any test substance concentrations in the absence and the presence of metabolic activation system.
In an in vitro chromosome aberration test performed according to OECD guideline No 473 and in compliance with GLP, E96095 induced no
increase of chromosomal aberrations in human primary lymphocyte cultures in the absence and the presence of metabolic activation system.
in a mouse lymphoma assay performed according to OECD guideline No 476 and in compliance with GLP, E96095 induced no increase in cell mutants at any test substance concentrations in the absence and the presence of metabolic activation system.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
In two in vitro genotoxicity studies, a reverse gene mutation assay in bacteria and a chromosomal aberration test in human primary lymphocyte cultures, E96095 showed neither increase of bacterial revertants nor chromosomal aberrations, respectively, with and without metabolic activation system
In a third in vitro genotoxicity study, mouse lymphoma assay, E96095 induced no cell mutant increase with and without metabolic activation system.
Therefore, E96095 is not considered as genotoxic and not classified according to the CLP Regulation (1272/2008).
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