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EC number: 447-920-2
CAS number: 897393-42-9
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 (van Otterdijk,
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.
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
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.
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. This conclusion is in line
with the RAC opinion proposing harmonised classification and labelling
at EU level of the test substance, adopted 9 December 2016
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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