Registration Dossier

Administrative data

Description of key information

A study was performed to assess the irritatany potential of Danafloat 123, containing 49.2% EP1-Na, to the skin of rabbits. The method used followed the recommendations of the OECD guideline 404 and Method B4 of Comission Directive 92/69/EEC. 
A 4 -hour semi-occluded application of the test material to intact skin produced severe erythema and oedema besides other severe skin reactions. As well, exposure durations of one hour and 3 minutes resulted in well-defined erythema and very slight to slight oedema, loss of skin elasticity, skin discolouration, crust formation and reduced regrowth of fur. On occasions, it was not possible to accurately evaluate the erythema and oedema due to the other skin reactions observed.
The presence of scar tissue at one skin site following a 4 -hour exposure period was indicative of full thickness tissue destruction. The test material was therefore classified as corrosive. Classification according to the Draize system was not applicable.
Based on the results of the skin irritation study which resulted in a classification as corrosive, the eye irritation study is waved with respect to animals welfare.

Key value for chemical safety assessment

Additional information

According to regulation (EC) 1907/2006 of the European parliament and the council of 18 December 2006 (Article 17), no chemical safety assessment is required for on-site isolated intermediates. Therefore, no key values were defined for EP1.

Justification for classification or non-classification