Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Skin irritation/corrosion:

There are three reports available. Among these, the study by Atochem was identified as the key study because it was conducted according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register (USA)-29 FR13009, 1964 (Atochem, 1980). The test substance was administrated to the intact and abraded skin of New-Zealand albino rabbits at the dose level of 0.5 mL per animal under an occlusive patch for 24 hours. The cutaneous reactions were observed just after the removal of the patch and after 72 hours. Severe erythema, oedema and necrosis were observed after the test, and these symptoms persisted to the inspection after 72 hours of the test. The obtained primary irritation score was 8.0. Under these test conditions, the test substance was considered to be corrosive to the skin.

In a second study in rabbits according to the method of Draize the test substance was considered to be highly irritating to the skin (Roehm, 1977). The test substance furthermore tested on the skin of guinea pigs resulting in highly irritating effects (Roehm, 1977).

Eye irritation:

The only study available was considered to be reliable because it was conducted in accordance with the recommendations of the Federal Hazardous Substances Labelling Act (Atochem, 1980). Severe cornea, iris and conjunctivae lesions were displayed in both rabbits within 2 hours after the instillation of 0.l mL undiluted test substance into the eye. The test substance was considered to be corrosive to the eyes.

Justification for classification or non-classification

According to Annex I of the Directive 67/548/EEC and according to Annex VI 1272/2008 CLP (UN GHS) the test substance is classified as irritating to skin (R38; Skin corrosion/irritation Cat. 2) and irritating to eyes (R36; Serious eye damage/eye irritation Cat. 2A). However, based on the results of two skin irritation studies in rabbits (Atochem, 1980; Roehm, 1977) and one eye irritation study in rabbits (Atochem, 1980), the test substance is considered to be corrosive to skin and eyes. Therefore, the following classification of the test substance is suggested (self-classification):

EU classification according to Annex VI of the Directive 67/548/EEC:

- Skin irritation/corrosion: Causes burns, R34

- Eye irritation: Results from eye irritation studies fulfill the criteria for assignment of the risk phrase "Risk of serious eye damage (R41)". However, since the substance is classified as corrosive and assigned R34, the risk of severe damage to eyes is considered implicit and R41 is not included in the label.

- Respiratory irritation: No classification required.

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

- Skin irritation/corrosion Cat. 1B

- Eye irritation: Cat. 1

- Respiratory irritation: No classification required.