Registration Dossier

Administrative data

Description of key information

Skin:
The test material was not irritating to the skin of the New Zealand White rabbit.
Eye:
The test material was found to be irritating to the eye of the New Zealand White 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:
adverse effect observed (irritating)

Additional information

Skin:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion". A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema at two treated skin sites. All treated skin sites appeared normal seven days after treatment. The test material produced a primary irritation index of 0.5. No corrosive effects were noted. Therefore the test material was regarded as non-irritant.

Eye:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion". A single instillation of the test material to the non-irrigated eye of three rabbits produced translucent or opalescent corneal opacity, iridial inflammation and severe conjunctival irritation. Other ocular effects noted were circumcorneal vascularisation, convoluted eyelids and dulling of the normal lustre of the corneal surface. The test material was classified as irritant.

The read across justification is given in an extra rationale document.


Justification for selection of skin irritation / corrosion endpoint:
valid guideline studies

Justification for selection of eye irritation endpoint:
valid guideline studies

Effects on eye irritation: irritating

Justification for classification or non-classification

No classification and labelling is required for skin irritation according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.

Based on eye irritation data available, the homologuous test item, and hence the registered substance is classified as eye irrit. cat. 2 A (H319: Causes serious eye irritation) according to Regulation No (EC) 1272/2008 (CLP) and as Xi; R36 Irritant; Irritating to eyes according to Directive 67/548/EEC (DSD) criteria.