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Description of key information

SKIN IRRITATION/CORROSION

Corrosive, New Zealand White rabbit, OECD 404 and EU Method B.4

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit in accordance with the standardised guidelines OECD 404 and EU Method B.4. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Available information indicated that the test material had the potential to produce severe irritation/corrosion; to confirm this initial assessment, an ex vivo pre-screen test, the Transcutaneous Electrical Resistance (TER) Assay, was performed. The results of the pre-screen test indicated that the test material was considered not to be corrosive to the skin and the in vivo study was performed.

0.5 g of the test material, moistened with distilled water, was applied under a gauze patch to the clipped skin of one rabbit. The patch was removed 3 minutes after application and any residual test material removed with cotton wool soaked in distilled water. The reaction of the skin was evaluated 1 hour and 24 hours following the removal of the patch.

The test material produced reactions indicative of dermal corrosion. The reactions included light green coloured dermal necrosis, surrounded by dermal haemorrhage, and a sunken, hardened dark brown/black coloured scab. The animal was killed for humane reasons immediately after the 24 hour observation, due to the irreversible effects.

Due to the corrosive reactions following an exposure period of 3 minutes, the 1 and 4 hour exposure periods were not investigated.

Under the conditions of this study, the test material was corrosive to rabbit skin.

 

On the basis of this result, the test material was also assumed to cause serious damage to the eye and no in vivo testing was carried out.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance requires classification with respect to skin corrosion and serious eye damage. The test material requires classification as skin corrosive Category 1A (H314 Causes severe skin burns and eye damage) and as eye damage Category 1 (H318 Causes serious eye damage).

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance requires classification with respect to skin and eye damage as R35 causes severe burns (C).