Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-784-2 | CAS number: 2530-83-8
In the key experimental non-LLNA skin sensitisation study, a Buehler test conducted with guinea-pigs, 3-(2,3-epoxypropoxy)propyltrimethoxysilane was not sensitising in guinea pigs (Hüls, 1993). Additionally, a good quality study that was conducted using human subjects also evidenced negative results (TKL Research, 2001).
There were no substance related effects or influence on body weight in either test or control animals. There was no erythema or edema observed during Induction Phase I, II or III; no skin irritation was observed in the control animals. There was no skin irritation observed in either test or control animals in the Challenge Phase.
In a well conducted Buehler test (reliability score 1) conducted to OECD 406 and GLP, DYNASYLAN GLYMO (glycidyloxypropyl-trimethoxysilan) was not a skin sensitiser in guinea-pigs.
The key study for skin sensitisation was conducted according to an OECD Test Guideline 406, and in compliance with GLP. The dose level selected in the range finding test, for the main study and challenge exposure, was 100% undiluted test substance. There was no substance related clinical effects in any of the test or control animals. Furthermore, no erythema or oedema during induction or challenge phase occurred. The positive and negative control animals gave expected responses. The substance was concluded to be not sensitising to Guinea pig skin in a well conducted Buehler test (Hüls, 1993).
A supporting repeated insult patch test with 3-(2,3-epoxypropoxy)propyltrimethoxysilane is also included in the data set. The objective of the study was to determine the ability of the test material to cause sensitisation by repeated applications to the skin of selected human subjects. A semiocclusive application of 1% of the test material to 111 subjects over a 6 week period comprising of an induction, rest and challenge phase was carried out. The subjects were between 20 and 75 years old with a mean age of 47.9 years and mainly of Caucasian origin. One-hundred subjects completed the study. There were no dermal reactions noted during induction or challenge with the test article. Under the conditions of this study, there was no evidence of sensitisation to the test article (TKL Research, 2001).
A supporting guinea pig maximisation tests (GPMT) which was conducted according to OECD Test Guideline 406, with acceptable restrictions, concluded that the test material is not sensitising to skin (Dow Corning Corporation, 1984).
In a Buehler test which was not conducted according to any guideline and not in compliance with GLP showed the test material to be a very slight sensitiser in guinea pigs (Dow Corning Corporation, 1982).
In a Buehler test which was conducted according to a test protocol comparable to OECD Test Guideline 406 and in compliance with GLP, the substance was reported to be a very slight sensitiser, although, this is considered to be ambiguous (FDRL, 1982).
The available data do not suggest that 3-(2,3-epoxypropoxy)propyltrimethoxysilane should be classified as a skin or respiratory sensitiser according to Regulation (EC) No. 1272/2008.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again