Registration Dossier

Administrative data

Description of key information

The substance is considered corrosive to the skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

A dye preparation containing 40% ethylviolet acetate, 17% acetic acid, 17% confidential component and 26% water was tested for its skin irritation/corrosion potential. In this Draize test intact and abraded skin of 6 rabbits was exposed to the undiluted preparation under occlusive conditions for 24 hours. The observation period was 8 days. Severe signs of skin irritation (erythema and edema) that were not reversible within the short observation period were observed on both intact and abraded skin. Irritation could have been caused by the acetic acid (17%). However, under the conditions of this study ethylviolet acetate is considered to be irritating to the skin.

Eye irritation:

The same dye preparation has been tested for its eye irritation potential according to Draize. The undiluted preparation (0.1 mL) was applied to one eye of six rabbits. The observation period was 8 days. Opacitiy of the cornea, iritis and redness of the conjunctivae could not be detected due to substance-induced coloration. The individual mean score for conjunctivae swelling was 2.7 in 3 animals and 4.0 in 3 animals, respectively. After 24 and 48 h, slightly increased discharge, after 72 h discharge with moistening of the lids and hairs, and considerable area around the eye was observed in all animals. Lymphoma was observed in 4 of 6 rabbits 72 h after the beginning of the study. After 8 days very severe edema, severe suppuration, bloody crusts and lymphoma were observed. Opacitiy of the cornea, iritis and redness of the conjunctivae could not be detected due to substance-induced coloration. Observed eye reactions could have been caused by other components of the product (acetic acid). However, under the conditions of this study ethylviolet acetate is considered to be severely irritating to the eye.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Ethylviolet acetate has to be classified as the available skin and eye irritation study showed that the substance was irritating for the skin and caused serious damage to the eyes (Xi; R38, 41 according to Directive 67/548/EEC). According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, this corresponds to classification with Category 2, H315: Causes skin irritation and Category 1, H318: Causes serious eye damage.

However, the substance registered in this dossier consists of 70% ethylviolet acetate, 25% acetic acid and some minor impurities not contributing to the classification. As acetic acid is classified as a corrosive substance, the presence of 25% acetic acid will have consequences for the classification. Therefore the substance has to be classified as corrosive (R34 according to Directive 67/548/EEC). According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, this corresponds to classification with Category 1B, H314: Causes severe skin burns and eye damage.