Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating

Eye irritation (OECD 405): not irritating

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

In a primary dermal irritation study (performed according OECD guideline 404, in compliance with GLP, 2004), 3 female New Zealand Albino rabbits were dermally exposed to 0.5 g test substance moistened with 0.5 mL sterile water for 4 hours under semiocclusive conditions. Animals then were observed for 3 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean scores for the 24, 48 and 72 h reading for erythema and edema for each animal was 0, respectively. No skin reactions were observed at the 1 -hour reading point. In this study, the test substance was not a dermal irritant.

 

Eye:

An eye irritation test was performed with three female New Zealand Albino rabbits and performed according to OECD guideline 405 in compliance with GLP (2004). Eyes were left unwashed after application of 0.1 g test substance and the animals were observed for 72 h. The mean scores for the 24-, 48- and 72-h reading for iritis, cornea opacity and conjunctivae chemosis were 0 at any reading time point. Conjunctivae redness of score 1 was observed in two animals at the 24-h reading time point which was fully reversible after 48 hours. In this study, the test substance is not an eye irritant.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.