Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A bacterial reverse mutation assay with S. typhimurium was conducted with 1,2 -Methylen-4,6 -dien concentrations from 0.1 to 5 mg per plate using the five histidine-dependent Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98 with and without metabolic activation. A cytotoxic effect was seen at from 2.5 mg/plate onwards with S9 mix and from 1.0 mg/plate onwards without S9 mix.

There was no evidence for a mutagenic activity of 1,2 -Methylen-4,6 -dien, when tested up to the precipitating and cytotoxic dose levels and the maximum recommended dose level of 5 mg/plate in the absence and presence of S9 mix.

Short description of key information:
Gene mutation in vitro (bacterial reverse mutation assay, GLP, equivalent to OECD TG 471): negative in the Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 100 and TA 98 with and without S9 mix
[Schering AG, Report No. X180 -draft-, 1996-12-13]

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.