Registration Dossier

Administrative data

Description of key information

The dermal irritant potential of the substance was assessed using:
- An in vivo acute dermal irritation/corrosion test performed in rabbit according to OECD 404 guideline and Good Laboratory Practices (Dufour, 1996)
The substance was found to be corrosive after 4 hours of exposure.
The ocular irritant potential of the substance was assessed using:
- The results of the acute dermal irritation / corrosion test performed on rabbit by Dufour (1996). Additional testing for eye irritation was scientifically not justified because of animal welfare reasons and the substance was considered to be corrosive for eyes.
No data were available to assess the respiratory irritant potential of the substance.

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)

Additional information

Skin irritation/corrosion:

One study was recorded for this endpoint. The study of Dufour (1996) was reliable without restrictions and was identified as a key study.

In this study, the potential of the substance to induce skin irritation was assessed in rabbit according to the OECD guideline 404 in compliance with the principles of Good Laboratory Practice regulations.

A single dose of 0.5 ml of the test substance wasapplied to the skin of the rabbits under a semi-occlusive dressing for a 4-hour exposure period and thereafter for 3 minutes . Skin reactions were observed 1, 24, 48, 72 hours after removal of the dressing and then daily until day 14in order to observe their reversibility. The mean values of the scores for erythema and oedema were calculated for each animal.

After 4 hours of exposure, the mean scores over 24, 48 and 72 hours for individual animals were 3.0, 2.3 and 3.0 for erythema and 2.0, 3.0 and 3.7 for oedema. Burns and loss of elasticity was noted in all animals after 48 hours. In one animal, a slight scab had broken out 72 hours later , a scar formation was visible at the end of the observation period. For all animals, erythema regressed slowly. It cleared on day 13 in one animal but was still barely perceptible at the end of the observation period for the two remaining. Oedema disappeared on day 5 in one animal and on day 11 in one other, a very slight oedema was still observed in the third one at the end of the observation period.

After 3 minutes of exposure, the mean scores over 24, 48 and 72 hours for individual animals were 1.7, 2.0 and 0.3 for erythema and 2.0, 1.0 and 1.3 for oedema. Animals demonstrated slight to well visible erythema and slight oedema. These symptoms were reversible for two rabbits within 5 and 10 days with the last animal displaying slight erythema at the end of the study period.

Under these experimental conditions, the test substance was considered to be corrosive to the rabbit skin.

Eye Irritation / corrosion:

No study was recorded for this endpoint. Based on the results of the in vivo skin irritation/corrosion study performed by Dufour (1996),

the substance was also considered to be corrosive for rabbit eyes.

Respiratory irritation:

No data were available.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin Irritation:

According to the results of the key study (Dufour, 1996) and the criteria laid down in EU directive67/548/EEC, the substance is classified Corrosive with the risk phrase R34.

Translation from classification according to DSD to the classification according to CLP is as follows: C, R34 after 4 hours of exposure is translated into Skin Corrosive Category 1C with the hazard statement H314 (Guidance on the application of regulation EC n°1272/2008 , page 240).

Eye Irritation:

Based on the above stated results on skin corrosion (Dufour, 1996),the substance must be considered as corrosive for eyes and warrants a classification in category 1 , eye damage according to CLP regulation (Reg 1272/2008/EC)and a classification severely irritating for eyes Xi, R41 according to the directive 67/ 548/ EEC.