Registration Dossier

Administrative data

Description of key information

The substance was found to cause a minimal irritation to the eye. A conclusion regarding skin irritation cannot be drawn.

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:

In a primary skin irritation test, tested according to the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO), 0.5 g test material was applied under occlusive conditions to the prepared (shaved) abraded and intact skin of 3 male and 3 female adult rabbits of the Himalayan breed. No erythema or edema was observed up to 7 days after exposure. The primary irritation index was 0.

However, the study is performed quite some time ago and does not comply to the current guidelines and to guidelines which were in place from 1992 on. The main objection is the fact that the test material was applied as a dry powder and not moistened sufficiently prior to application.

 

Eye irritation:

In an acute eye irritation study, tested according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO), 3 male and 3 female adult rabbits of Himalayan breed were exposed to 0.1 g test material, which was inserted into the conjunctival sac of the left eye. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The mean iris and conjunctiva score were 0 at all time points for both unrinsed and rinsed eyes. The mean cornea score of the unrinsed eyes at 24 hours was 1.67 and 0 at day 2-7. For the rinsed eyes the mean cornea score was 0 at all time points. The primary irritation index in unrinsed eyes is 0.33 and in rinsed eyes 0.

 

A test on skin irritation was performed as in vitro study. The EpiDerm system was used to evaluate the skin corrosion and the skin irritation potential by examination of the viability of the cells of the reconstructed skin model after 3 min and 1h or after 35 min exposure according to OECD guideline 431 and 439. The cell viability values obtained each for the corrosion and the irritation test are clearly above the threshold of 15% and 50%, respectively. The test material is therefore not considered to be irritating to skin.

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.

                                             

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.