Registration Dossier

Administrative data

Description of key information

Not irritating to rabbit skin in vivo. 
Not irritating to rat skin in vivo.
Not irritating to rabbit eye in vivo.

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

A primary skin irritation study was performed according to OECD Guideline 404 (Sanders, 2010c). The clipped skin in the dorsal trunk area of two New Zealand White rabbits was exposed to 0.5 g of the solid test substance moistened with 0.5 mL distilled water for 4 hours under semi-occlusive conditions. In the first animal two additional skin sites were exposed for 3 minutes and 1 hour. The observation period was 72 hours. Treated skin sites were assessed according to the Draize scheme for primary skin irritation. No skin irritation was observed at any of the examination time points in any of two treated animals.

Within an acute dermal toxicity study performed according to OECD Guideline 402 (Sanders 2010b) groups of five male and five female Wistar rats were dermally exposed to 2000 mg/kg bw test substance moistened with distilled water for 24 hours under semiocclusive conditions. The treated skin sites were examined for primary skin irritation once daily during the 14 -day observation period according to Draize system. No skin irritation was observed in any of the treated animals at any examination time point.

An acute eye irritation study according to OECD guideline 405 has been performed in New Zealand White rabbits (Sanders, 2010d). 0.1 mL of the test substance as it was instilled in one eye of 3 animals and the scores according to Draize were reported after 1, 24, 48 and 72 hours. There were only slight irritations on the conjunctiva, which were fully reversible within 7 days. No clinical signs, abnormal body weight changes or systemic toxicity had been observed.

Justification for classification or non-classification

No classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC) classification criteria for corrosion/irritation.