Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

Skin irritation was tested using an internal standard method (BASF, 1978). This study meets scientific standards with acceptable restrictions (limited documentation).

Two White Vienna rabbits were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the test substance.

The test substance induced erythema after 20 h occlusive exposure (reversibel within 7 d) in 1/2 animals; 15 min exposure did not cause any irritation effects.

Eye irritation

Eye irritation was tested in a study comparable to OECD Guideline 405 with acceptable restrictions (BASF AG, 1978). 50 mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The talcum-treated adjacent eye served as a control.

Corneal opacity and iritis were not observed; slight chemosis was observed only at the day of application. Conjunctivae redness was observed in both animals as reversible effect within one and eight days, respectively. Effects observed were equivalent to the effects of the negative control (talcum).

Justification for classification or non-classification

Classification is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.