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EC number: 220-011-6
CAS number: 2602-34-8
In an acute oral toxicity study,
conducted according to OECD Test Guideline 401 and in compliance with
GLP, the LD50 for [3-(2,3-epoxypropoxy)propyl]triethoxysilane
was >2000 mg/kg bw in rats (RCC, 1994). There were no clinical signs of
In a good quality acute
inhalation study (Allied Corporation, 1982) conducted according to OECD
403, and in compliance with GLP, an aerosol of unchanged Prylog (Silane,
trimethoxy 3-(oxiranylmethoxy) propyl) gave an LC50greater
than 5.3 mg/l in rats.
In an acute dermal toxicity
study, read-across from [3-(2,3-epoxypropoxy) propyl]silane (Mellon
Institute, 1962), the LD50was 4250 mg/kg bw for males only.
There were no mortalities or clinical signs, but necropsy findings
included congested lungs, mottled livers with prominent acini, and
off-colour kidneys with internal congestion.
Table of concentrations and particle sizing data of Prylog (mg/l and µm)
In a good quality acute inhalation study (reliability score 1) conducted
according to OECD 403, and in compliance with GLP, an aerosol of
unchanged [3-(2,3-epoxypropoxy)propyl]trimethoxysilane gave an LC50
greater than 5.3 mg/l in rats.
In a pre-GLP, pre-guideline dermal irritation study (reliability score
2), conducted using a protocol comparable to OECD 402, the LD50 for
[3-(2,3-epoxypropoxy)propyl]trimethoxysilane was 3.97 ml/kg bw (using a
density of 1.07 g/cm3 this gives an LD50 of 4250mg/kg bw) in rabbits.
are no acute inhalation or dermal toxicity data for [3-(2,3-epoxypropoxy)propyl]triethoxysilane
its hydrolysis product, 2,3-dihydroxypropoxypropylsilanetriol,
so good quality data for the related substance
[3-(2,3-epoxypropoxy)propyl]trimethoxysilane have been used as
read across. Justification of read-across is provided in the
document attached in Section 13.
hydrolyses in contact with water (half-life predicted to be
approximately 12-36 hours at pH 7), generating ethanol and 2,3-dihydroxypropoxypropylsilanetriol
whereas the read across substance
hydrolyses faster (6.5 hours at pH 7) into 2,3-dihydroxypropoxypropylsilanetriol
and methanol. At 37.5°C
(relevant for inhalation exposure), the corresponding half-lives are 2.3
and 4 -13 hours, respectively (see Section 5.1.2). The
registered substance and the read-across substance therefore generate a
common silanol hydrolysis product, and ethanol and methanol,
respectively. Ethanol and methanol are not acutely harmful to rats. For
the purpose of assessing acute toxicity via the inhalation route by read
across, the hydrolysis rate of both parent materials is similar enough
in that the half-life exceeds the exposure time, therefore
initial exposure is mainly to parent material.
In addition to the read
across, a reliable acute toxicity oral study is available for the
registration substance (RCC, 1994); the LD50value is above
2000 mg/kg bw/day and showed no indication of significant clinical or
systemic effects following a single dose, except at very high dose
levels well in excess of the highest dose level in current guidelines
for acute toxicity.
therefore considered appropriate to read-across acute inhalation and
dermal data from the trimethoxy to the triethoxy analogue. Additional
information is given in a supporting report (Peter Fisk Associates,
in Section 13 of the IUCLID dossier.
Justification for selection of acute toxicity – oral endpoint
The selected study is the only available acute oral toxicity study
for the registered substance. It was conducted in accordance with an
appropriate OECD Test Guideline 401 and in compliance with GLP.
Justification for selection of acute toxicity – inhalation endpoint
The selected study is the only reliable acute inhalation study
available for the most relevant surrogate substance. It was conducted in
accordance with an equivalent OECD Test Guideline 406 and in compliance
Justification for selection of acute toxicity – dermal endpoint
The selected study is the only reliable acute dermal toxicity study
available for the most relevant surrogate substance. It pre-dated both
OECD guidelines and GLP but was conducted according to a protocol that
was similar to OECD 402.
Based on the available acute oral and read-across inhalation data
[3-(2,3-epoxypropoxy)propyl]triethoxysilane is not classified for acute
toxicity 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.
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