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EC number: 203-529-7 | CAS number: 107-88-0
Skin irritation:Human data reveal no or only minimal skin irritating properties of the undiluted substance or a 50% aqueous solution. This is supported by animal studies with neat substance, where no or only minimal signs of skin irritation are documented, which is not.Eye irritation: relevant with respect to classification.The key study documents a slight irritating effect in the eyes of rabbits, and several further animal studies showed no or only minimal eye irritation. Human data are restricted to a short remark in a handbook, which reports that the substance caused stinging, when it was applicated to the human eye and there was a rapid complete relief after rinsing-off the material.
The cumulative irritation at repeated application (6 weeks of exposure) was also tested. The mean maximum cutaneous index (MMII) was as follows:
10% aqueous solution: 0 (very well tolerated)
100%: 0.58 (relatively well tolerated)
Rabbits were exposed dermally to single doses of undiluted test substance. No acute irritation was observed (Guillot et al., 1982).
no skin reaction from undiluted sample observed
When rabbits were exposed dermally to the undiluted test substance for 24 h, no skin irritation was observed (Smyth et al.,1951).
The undiluted test substance produced a slight irritation of the rabbit's eye (Guillot et al., 1982).
There is no study available which fulfills the requirements of current OECD guidelines. However there is sufficient information available to enable the evaluation of this endpoint in a weight of evidence approach, both from investigations in humans as well as in animals. In a human study 200 volunteers were exposed to 50% aqueous solution of the test substance for 15 times (24 h each) within 5 weeks (exposures on Monday, Wednesday and Friday) by occlusive patch exposures at the upper arm. A mild skin irritation was reported in 2 subjects. After changing the site of application, no further signs of irritation were observed in these individuals (Shelanski, 1973, 1974).
The result of this study is supported by another clinical trial, where 37 and 39 volunteers were exposed to neat substance for 24 h by occlusive or semiocclusive patches, respectively. Only one subject of the semiocclusive group showed mild skin irritation (CTFA, 1985). Also, no skin irritation was reported in another study with human volunteers after single and repeated exposure (Loeser, 1949).
Additionally, in an animal study with rabbits, which were exposed for 24 hours on intact or abraded skin and which were evaluated immediately after end of exposure or 48 hours after end of exposure, no skin irritation was observed (Guillot et al., 1982). Smyth et al. (1951) also reported that no skin irritation was observabed in rabbits after 24 hour exposure to neat substance. Further studies with animals of several species (rat, rabbit, guinea pig), which are insufficiently documented for evaluation, consistently reported no or only minimal skin irritation (CTFA, 1985; Fischer et al., 1949, ; Loeser, 1949). Overall, various data available from humans and animals provide consistent information indicating that butane-1,3 -diol is not or only veryl slightly irritating to skin and that no classification for this endpoint is required.
Immediate stinging was reported after application of one tiny drop into the human's eye, irrigating with water brought a rapid complete relief (Grant, 1974). The undiluted substance caused only slight irritation in the eye of rabbits (Guillot et al., 1982; key study). A (incompletely reported) Draize test (Watanabe et al., 1949) and other animal data (Carpenter et al., 1946; CTFA, 1985; Fischer et al., 1949; Loeser, 1949; Smyth et al., 1951) showed no eye irritating potential.
Based on the available data, according to Directive Regulation (EC) No 1272/2008 no classification is required with respect to skin or eye irritation.
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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