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Administrative data

Key value for chemical safety assessment

Additional information

Endpoint Conclusion:

Justification for classification or non-classification

There are no data available on aldonaethylenolether, but a GLP-guideline study to test the mutagenic potential of aldona, the pharmacological active metabolite of aldonaethylenolether, in a bacterial reverse mutation assay (Ames test) was conducted. In this study aldona did not show a mutagenic potential in the Salmonella typhimurium strains TA 98, TA 100, TA 1538, TA 1535 and TA 1537 with and without metabolic activation when tested up to the highest recommended dose level of 5.0 mg/plate [Schering AG, Report No. X513 -draft-; 2000 -12 -05; OECD TG 471]. Therefore, also aldonaethylenolether, which will be metabolized in vivo to the pharmacological active aldona, can be expected to show no mutagenic potential.

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.