Registration Dossier

Administrative data

Description of key information

The test item was tested for skin irritation in a GLP study according to OECD 404 in rabbit. The test item is considered to be a "non-irritant" to the skin of rabbit.
The test item was tested for eye irritation in a GLP study according to OECD 405 in rabbit. The test item is considered to be a "non-irritant" to the eye of rabbit.

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 irritation/corrosion

The irritation/ corrosion potential of the test item was evaluated using New Zealand White rabbit according to OECD 404, adopted in 1992. Each of six rabbits received a 0.5 g dose of the test article as a single dermal application. Each test site was moistened with deionised water to enhance test article contact with the skin. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using wet tissue. Test sites were subsequently examined and scored for dermal irritation for up to 72 hours after patch removal. Exposure to the test article produced no signs of erythema or oedema. The mean score (edema or erythema) that each animal obtained was 0. Therefore, under the selected test conditions, the test item is considered to be "not irritating" to skin.

Eye irritation

The irritation/ corrosion potential of the test item was evaluated in the eyes of New Zealand White rabbits, according to OECD 405, adopted in 1992. Each of three rabbits received 0.1 mL weight equivalent dose of the test item in the conjunctival sac of the right eye. The left eye remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 72 hours after application. 2/3 animals showed very light redness and 1/3 showed slight cornea opacity. All signs of toxicity were fully reversible within the 72- hour observation period. The mean (conjuctivae or chemosis or cornea or iris) score that each animal obtained was 0 or between 0 to 1. Therefore, under the selected test conditions the test item was considered to be "not irritating" to eye.


Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline compliant

Justification for selection of eye irritation endpoint:
GLP and guideline compliant

Justification for classification or non-classification

Based on the results of the skin irritation study the test item is not subjected to classification and labelling for skin irritation/ corrosion effects according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (CLP).

Based on the results of the eye irritation study the test item is not subjected to classification and labelling for eye irritation/ corrosion effects according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (CLP).