Registration Dossier

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Administrative data

Key value for chemical safety assessment

Additional information

Oxaphthalimid was shown to be not mutagenic with and without metabolic activation in a bacterial reverse mutation assay with the S. typhimurium strains TA 1535, TA 100, TA 1537, TA 98 and TA 102. The study was conducted using the plate incorporation and preincubation method with substance concentrations from 50 to 5000 µg per plate.

Short description of key information:
Gene mutation in vitro (bacterial reverse mutation assay, GLP, OECD TG 471, EU Method B. 13/14, EPA OPPTS 870.5100): negative in all tested Salmonella typhimurium strains
[Bayer AG, Report No. PH-34867, 2007-04-13]

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.