Registration Dossier

Administrative data

Description of key information

Based on the outcome of two in-vivo studies on skin and eye irritation, the substance needs not to be classified for its irritating properties. In both studies mild irritating effects were reported.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation study:

Under the conditions of this study, the substance resulted in very slight erythema in all three animals. The erythema was reversible within 24 hours after exposure in one animal and within 48 hours i n the two other animals. In the area of application, blue staining of the treated skin by the test substance was observed. No corrosive effect occurred on the skin i n any of the rabbits. No signs of systemic intoxication were observed during the study period. The substance resulted in a primary irritation index of 0.3 (mildly irritating) when applied to the intact rabbit skin.

Eye irritation study:

Under the conditions of this study, the substance resulted in adverse effects of the cornea and the conjunctivae. The opacity of the cornea was reversible within 24 hours and the irritation of the conjunctivae was reversible within 7 days in all three animals. No ocular corrosion was observed in any of the animals. No signs of systemic intoxication were observed during the study period. The test substance should be considered mildly irritating (M2) to the rabbit eye (Kay and Calandra interpretation of the Draize score : 10 ).


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Conclusion on the skin irritation study:

The substance resulted in a primary irritation index of 0.3 (mildly irritating) when applied to the intact rabbit skin. According to the EEC criteria for classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC), the substance needs not be labelled as a skin irritant. The same conclusion applies to the new CLP regulation EC 1272/2008.

Conclusion of the eye irritation study:

The test substance should be considered mildly irritating (M2) to the rabbit eye. According to the EEC criteria for classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC), the substance. needs not be labelled as an eye irritant. The same conclusion applies to the new CLP regulation EC 1272/2008.