Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The irritation potential has been assessed to the skin and eye of rabbits

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

All skin irritation data available demonstrate that the substance tested was not irritant to the skin.

In an ex-vivo chicken enucleated eye the substance tested caused severe loosening of the epithelium and the study terminated after the 30 minute observation period.

Two in vivo eye irritation studies demonstrate reactions that are considered of sufficient severity to regard the test samples as irritant to the eye, generally due to corneal effects. The effects were generally reversible and of sufficient severity to consider the substances to be irritating but not corrosive.

The remaining eye irritation studies produced low levels of background irritation that were of sufficient severity to regard the test substances as not irritating to eyes under the conditions of the tests.


Effects on eye irritation: irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the data available for skin irritation the substance is considered to be not irritating to the skin.

The data available following exposure to eyes does, however, raise some cause for concern with regard to the substance. The only in vitro/ ex vivo study available resulted in the tests substance being considered corrosive. Such studies are, however, generally considered to be adequate for screening purposes only and are not adequate to distinguish between irritation and corrosivity. The conclusion of this report has not been demonstrated in any of the available in vivo studies available.

Two in vivo studies gave cause for concern that this category of substance has the potential to be irritating to eyes while four in vivo tests suggest that the category of substance is not irritating to eyes.

Although there is a weight of evidence to suppose that this category of substance may not be irritating to eyes, the results from two in vivo and on in vitro study is considered statistically significant and that the precautionary principle for hazard assessment should be applied in this case.

It is, therefore, considered most appropriate that the substance should be classified as irritating to eyes with the label R36, Irritating to eyes.

Categories Display