Registration Dossier

Administrative data

Description of key information

The test item was applied onto skin and into eyes of  rabbits for four hours to determine the irritation potential. The substance caused mild transient redding of the eyes and chemosis. These effects were reversible within 7d. Effects on skin were not observed. Both studies were conducted according GLP and OECD guidelines (404 and 405).

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

Procedure and observations

The primary skin irritation potential of the test substance was investigated by topical semiocclusive application of 0.5 g to the intact left flank of each of three New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. The application of the test item to the skin resulted in light red staining of the treated skin throughout the whole study in one animal, up to the 72 hours or 7 day observation in the two remaining animals. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals.

The primary eye irritation potential of the test substance was investigated by instillation of 0.1 g into the left eye of each of three New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application. The instillation of the test article into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. Slight staining of the treated eyes produced by the test item was observed in all animals at the 1-hour reading and in two animals at the 24-hour reading.

Discussion

Application of the substance onto skin or into eyes did not cause significant or irreversible damage. The only remarkable effect was red staining of skin or eyes. The test item is not irritating to skin or eyes.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified as irritating for skin or eyes under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.

                                             

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).