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Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

There are no data available on aldonaethylenolether, but a GLP-guideline study to test the eye irritating properties of aldona, the pharmacological active metabolite of aldonaethylenolether, was conducted. In this study the instillation of 0.1 g aldona into the right eyes of 3 albino rabbits caused a slight to clear redness of the conjunctivae in all three animals and a slight swelling of the conjunctivae in one animal after one hour. 24 h after instillation no signs of irritations were observed. The cornea and the iris were not affected. According to EU classification criteria, aldona is not an eye-irritant [Schering AG, Report No. A03230; 2001-02-26; OECD TG 405]. Since aldona is the pharmacological active metabolite of aldonaethylenolether also aldonaethylenolether can be expected to lead to the same effects as aldona.

Moreover, occlusive application of 2000 mg/kg aldona to rats (3/sex) for 24 h in an acute dermal toxicity study did not result in any skin alterations [Schering AG, Report No. A03234; 2001-02-26]. Therefore, aldona can be regarded as not skin-irritating. Since aldona is the pharmacological active metabolite of aldonaethylenolether, also aldonaethylenolether can be regarded as not skin-irritating.

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