Registration Dossier

Administrative data

Description of key information

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

Additional information

For the skin irritation a Klimisch 1 study is available. The acute dermal irritation of P5524- which contains 102% DEC - to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 404 and EU Method B.4 (Coles 1990). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. For the acute dermal irritation testing in 3 rabbits (2 males and one female, approx. weight of 2.19 - 2.26 g on day of application) 500 mg test item moistened with water was administered to the clipped skin. Application was performed for 4 hours. The skin were examined according Draize J.H. (1959). Well-defined or moderate erythema with moderate to severe oedema was noted during the study. Other adverse reactions noted were haemorrhage of the dermal capillaries, hardened dark brown/black-coloured scab, moderate erythema surrounding scab, blanching, dried blood, scab lifting at edges to reveal further dried blood and sunken hardened dark brown/black-coloured scab resembling a crater. At some treated skin sites the reaction extended beyond the treatment site. Reactions were indicative of corrosion. It can be concluded that under the experimental conditions the test substance is corrosive when administered by dermal route to rabbits. According to the classification criteria laid down in the Commission Directive 93/21/EEC the test item required to be classified as corrosive to the skin.

The results of this skin irritation study are considered relevant for the classification and labelling.

Based on the corrosive effects observed in the skin irritation study, the eye irritation study was omitted.


Justification for selection of eye irritation endpoint:
Based on the corrosive effects observed in the skin irritation study, the eye irritation study was omitted.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Based on the skin corrosion and likely eye damage, classification is warranted.