Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: In a primary skin irritation/corrosion study in 1 male New Zealand White rabbit, performed according to OECD Guideline 404, EPA OPPTS 870.2500 and JMAFF Japanese Test Guideline, the test substance was observed to be corrosive to the skin (F.M. van Otterdijk (2003)).
Eye irritation test: According to the REACH Regulation (Annex VII column 2 adaptation), an eye irritation test does not need to be performed if the substance is corrosive to the skin.

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

Skin irritation/corrosion:

F.M. van Otterdijk (2003) performed a primary skin irritation/corrosion study in 1 male New Zealand White rabbit (semi-occlusive application). The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B4, "Acute Toxicity - Skin irritation", OECD No. 404, "Acute Dermal Irritation/Corrosion" and US EPA OPPTS 870.2500, Acute Dermal Irritation and JMAFF, Japanese Test Guidelines.

Initially, one rabbit was exposed to three samples of 0.5 mL of the substance applied to separate skin-sites on intact, clipped skin using a semi-occlusive application. The exposure periods were 3 minutes and 1 hour, respectively. Based on the severity of the skin reactions, no further animals were exposed and the initially treated animal was sacrificed after a 1 -hour exposure period. A 3 -minute exposure to 0.5 mL of the substance resulted in well defined erythema in the treated skin area. A 1 -hour exposure resulted in severe erythema and slight oedema. In addition, gray discolouration of the treated skin (sign of necrosis) and a wound with serious exudate were seen on the 1 -hour treated skin sites. Evidence of full thickness destruction of the skin (wounds and gray discoloration of the skin) was observed immediately after a 1-hour exposure period, indicating that corrosion of the skin had occurred by dermal application of the substance to the intact rabbit skin.

Eye irritation:

According to the REACH Regulation (Annex VII column 2 adaptation), an eye irritation test does not need to be performed if the substance is corrosive to the skin.


Justification for classification or non-classification

Based on the available test results and according to the CLP Regulation, the substance should be classified as corrosive to the skin category 1B; H314 and as serious eye damaging category 1.