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EC number: 211-989-5
CAS number: 732-26-3
A single study assessing each of the endpoints (skin and eye) was available. Both studies were awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). In the studies the substance was found not to warrant classification as an irritant to skin or eye.
A study was performed to assess the irritancy potential of the test
material in accordance with the standardised guidelines OECD 404 and EU
Method B.4 under GLP conditions.
A single application of 0.5 g of the test material moistened with 0.5 mL
of distilled water was made to the clipped skin of 3 male New Zealand
White rabbits. The skin was exposed in a semi-occlusive fashion for a
period of 4 hours.
Following the exposure period, any residual test material was removed by
gentle swabbing with cotton wool soaked in diethyl ether. Approximately
one hour following the removal of the patches, and 24, 48 and 72 hours
later, the test sites were examined for evidence of primary irritation
and scored according to the Draize scale.
Very slight erythema was noted at all treated skin sites one hour after
patch removal and at one treated skin site at the 24 and 48-hour
observations. Very slight oedema was noted at one treated skin site one
hour after patch removal.
All treated skin sites appeared normal 72 hours after treatment.
Under the conditions of this study the test material was determined to
be non irritating to the skin
The irritancy potential of the test material was investigated in a study
conducted in accordance with the standardised guidelines OECD 405 and EU
Method B.5 under GLP conditions.
A single application of the neat test material was made to the
non-irrigated eye of three New Zealand White rabbits. One rabbit was
initially treated. Immediately after administration of the test material
an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first
treated animal, two additional animals were treated. In order to
minimise pain on installation of the test material, one drop of local
anaesthetic (Ophthaine, 0.5 % proxymetacaine hydrochloride) was
instilled into both eyes of the third animal 1 to 2 minutes before
Assessment of ocular damage/irritation was made approximately 1 hour and
24, 48 and 72 hours following treatment, according to the Draize scale.
Any other adverse ocular effects were also noted.
No adverse corneal effects were noted during the study. Iridial
inflammation was noted in two treated eyes one hour after treatment; no
other adverse iridial effects were noted. Minimal conjunctival
irritation was noted in all treated eyes one hour after treatment and in
two treated eyes at the 24-hour observation. No adverse ocular effects
were noted 24 to 48 hours after treatment.
Under the conditions of this study the test material was found to be non
irritating to the eye.
In accordance with the criteria for classification as defined in
Annex I, Regulation (EC) No. 1272/2008, the substance does not require
classification with respect to irritation or corrosion to the skin and
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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