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EC number: 203-444-5
CAS number: 106-93-4
Ágh, 2010, assessed the corrosive potential of the registered substance using fully validated in vitro methods. This additional study was necessary due to the corrosive findings of Rowe et al, 1952. Rowe et al, 1952, reported only a 'simple' irritation to the rabbit ear, however when the substance was in contact with the skin on the belly of the animal a corrosive response was noted.Ágh, 2010, reported a negative response for corrosivity in the in vitro test, however as a positive irritation response was noted by Rowe et al, 1952, it is considered that a weight of evidence approach between the two studies be used.Rowe et al, 1952, also conducted an assessment of the eye irritation potential of the registered substance. Using a test method similar to the OECD 405 guideline irritation was noted in all test eyes, however, where the substance was washed out after application or where a high (>10%) concentration was applied a more severe reaction was noted.
Ágh, 2010, was conducted in order to assess the corrosive potential
reported by Rowe et al, 1952, when the registered substance was placed
in contact with the skin. The dermal absorption of the registered
substance has been determined in other endpoints to be of high
potential, however the corrosive potential noted by Rowe et al, 1952,
was not observed in other endpoint studies. The in vitro method used was
fully validated and suitable for the regulatory endpoint. Under the
conditions of the test the registered substance produced a negative
effect for corrosivity and based upon this new evidence the susbtance
cannot be considered to be corrosive.
Rowe et al, 1952, provides information on both skin and eye irritation.
Skin irritation was assessed by exposing the rabbit ear to a 1% solution
of the registered substance in butyl carbitol acetate 10 times over 14
days in vivo. The registered substance caused only slight irritation to
the rabbit ear, however then exposed to the skin on the belly of the
animal the registered substance caused a severe burn and was absorbed
through the skin.
Eye irritation was assessed in a similar manner to the OECD 405
guideline, however the registered substance was applied to both eyes,
with a single eye being washed after 3 minutes. The registered substance
caused more damage in eyes that were washed after 3 minutes of exposure
than eyes that were not washed. It was therefore concluded that the
registered substanceis not likely to cause permanent damage to the eye,
however will cause pain and soreness for several days after exposure.
Strong solutions (10% or more) may cause more serious injury than the
The registered substance is currently classified as R36/37/38:
Irritating to eyes, respiratory system and skin according to Annex I of
67/548/EEC and Eye Irrit. 2, STOT SE 3 and Skin Irrit 2 according to
Annex VI of EC Regulation 1272/2008.
The information presented above supports this assessment therefore no
changes to the classifications are proposed at this time.
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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