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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)propyl]trimethoxysilane was not sensitising in
guinea pigs (Hüls, 1993). Additionally, a good quality study that was
conducted using human subjects also evidenced negative results (TKL
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)propyl]trimethoxysilane 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
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)propyl]trimethoxysilane should be classified as a
skin or respiratory sensitiser according to Regulation (EC) No.
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