Registration Dossier

Administrative data

Description of key information

The key study found the test material to be not irritating to the skin of rabbits in a study conducted according to OECD TG 404 and in compliance with GLP (NOTOX, 2003a).
The key study found the test material to be irritating to the eyes of rabbits in a study conducted according to OECD TG 405 and in compliance with GLP (NOTOX, 2003b).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key study for skin irritation was conducted according to OECD TG 404 and in compliance with GLP (NOTOX, 2003a). Diffuse and speckled erythema was noted in one animal between 24 and 72 hours. The skin irritation had resolved within 14 days after exposure in all animals. It is concluded that the test substance is not irritating to the skin.

The key study for eye irritation was conducted according to OECD TG 405 and in compliance with GLP (NOTOX, 2003b). The irritant effects reported in the study included corneal opacity, epithelial damage, iridial irritation and conjunctival redness, chemosis or discharge at the maximum grade of 1. All effects were fully resolved by Day 7. There was no evidence of ocular corrosion. The test substance is classified as a category 2 eye irritant, based on the conjunctival redness reading of >2 in 3 animals.


Justification for selection of skin irritation / corrosion endpoint:
The study was conducted according to an appropriate guideline and in compliance with GLP.

Justification for selection of eye irritation endpoint:
The study was conducted according to current guideline and in compliance with GLP.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the available in vivo studies, the test substance is not classified for skin irritation, but is considered Category 2: Irritating to Eyes, H319: Causes serious eye irritation, in accordance with Regulation (EC) No. 1272/2008.