Registration Dossier
Registration Dossier
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EC number: 618-251-5 | CAS number: 89182-60-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
A bacterial reverse mutation assay with S. typhimurium was conducted using N-Formylaminosorbit concentrations from 8 to 5000 µg per plate. Doses up to and including 5000 μg/plate did not cause any bacteriotoxic effects. N-Formylaminosorbit was not mutagenic with and without metabolic activation in all tested S. typhymurium strains (TA 1535, TA 100, TA 1537 and TA 98).
A chromosome aberration test in vitro was conducted in Chinese hamster V79 cells. The cells were treated with 525, 1050 and 2100 µg/ml N-Formylaminosorbit with and without S9 mix for 4 h and additionally, with the same concentrations without S9 mix for 18 h. Without S9 mix cytotoxic effects were observed at 2100 µg/ml only after 4 h treatment. With S9 mix no cytotoxic effects were observed. None of these cultures showed statistically significant or biologically relevant increases of numbers of metaphases with aberrations. Therefore, N-Formylaminosorbit is considered not to be clastogenic for mammalian cells in vitro.
Short description of key information:
Gene mutation in vitro (bacterial reverse mutation assay, GLP, OECD TG 471): negative in the Salmonella typhimurium strains TA 1535, TA 1537, TA 100 and TA 98 with and without S9 mix
[Bayer AG, Report No. 19393, 1990-08-08]
Chromosome aberration in vitro (Chinese hamster V79 cells, GLP, OECD TG 473, EU Method B.10, OPPTS 870.5375): negative with and without S9 mix
[Bayer AG, Report No. PH-34432, 2006-04-27]
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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