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EC number: 219-784-2
CAS number: 2530-83-8
The key acute oral toxicity study conducted according to a protocol
similar to the now deleted OECD Test Guideline 401, however, not in
compliance to GLP, reports an LD50 of 8025 mg/kg bw (Dow Corning
The key acute inhalation study which was conducted according to OECD
Test Guideline 403 and in compliance with GLP, reports an LC50 of >5300
mg/m3 (>5.3 mg/l) (Allied Corporation, 1982).
The key acute dermal study which was pre-guideline and pre-GLP, however,
similar to OECD Test Guideline 402, reports an LD50 was 4250 mg/kg bw
(Mellon Institute, 1962).
Table 1 Summary of mortality data.
In an acute oral toxicity study (reliability 2) that was conducted using
a protocol similar to the now deleted OECD 401 (animals were not weighed
and no necropsies were performed), but not to GLP, the LD50
for gamma-glycidyloxypropyltrimethoxysilane was 7.5 ml/kg bw (assuming a
density of 1.07g/cm3 this gives an LD50 of 8025 mg/kg bw).
Table of concentrations and particle sizing data of Prylog (mg/l and µm)
In a good quality acute inhalation study (reliability score 1) conducted
to OECD 403, and 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 glycidoxy propyltrimethoxysilane was 3.97 ml/kg bw (using a density
of 1.07 g/cm3 this gives an LD50 of 4250 mg/kg bw) in rabbits.
The key study for acute oral toxicity was conducted using a protocol
similar to the now deleted OECD Test Guideline 401 (animals not weighed
and no necropsies performed), but which pre-dated GLP, reported an LD50
of 7.5 ml/kg bw (equivalent to 8025 mg/kg bw). Clinical signs included
piloerection and lethargy within one hour of administration, followed by
coma and death. All deaths occurred within 48 hours of administration
and all survivors were generally asymptomatic after this time. Effects
on body weight were not recorded and no necropsy was carried out (Dow
Corning Corporation, 1976).
A supporting study is available for acute oral toxicity wherein no
deaths were observed and therefore, an LD50 of >5ml/kg was reported
(equivalent to 5350 mg/kg bw) (Dow Corning Corporation, 1976).
A study which was conducted in a similar way to OECD Test Guideline 401
and which pre-dated GLP, reported an LD50 of 8.4 g/kg (equivalent to
8400 mg/kg). The result was disregarded as the test was performed at the
Industrial BioTest laboratory (Dow Corning Corporation, 1963). The
result was disregarded as the test was performed at the Industrial
A supporting study which was pre-guideline pre-GLP, however, meets
generally accepted scientific principles, is in agreement with the other
studies, and an LD50 of 22.6 ml/kg bw was reported (equivalent to 24 182
mg/kg bw) (Mellon, 1962).
A supporting acute oral toxicity study conducted using a protocol
similar to the now deleted OECD Test Guideline 401 but not in compliance
with GLP, reports an LD50 of 16 900 mg/kg bw in rats (Allied
A reliability 4 acute oral toxicity study is also included in the data
set and reports that the dose of 2000 mg/kg bw registered substance did
not produce any signs of toxicity within 20 to 30 minutes of dosing (WIL
The key study for acute inhalation toxicity was conducted according to a
test protocol that is comparable to OECD Test Guideline 403, and in
compliance with GLP. The clinical signs included excessive lacrimation,
dry and moist rales, nasal discharge and yellow staining in the anal
genital area. The signs were considered to be dose related and were not
generally observed during the second week following exposure. There was
a transient dose-related body weight depression seen in all groups,
including control animals during the first week, however, mean body
weights exceeded pre-exposure values in all groups by day 14. Gross
pathology findings included discoloured lungs and autolytic changes in
three rats which died. There were no gross abnormalities noted at the
necropsy of survivors. The LC50 was reported to be >5.3 mg/L air
following a 4 hour whole body exposure to the aerosol of the test
material (Allied Corporation, 1982).
In a supporting acute inhalation toxicity study which was not conducted
according to any guideline and not in compliance with GLP, reported an
LC50 of >2.7 mg/L following four hours exposure to the test substance
(Dow Corning Corporation, no year).
A supporting acute inhalation toxicity study was also available which
has reliability 4, is similar to OECD Test Guideline 403, however not in
compliance with GLP. An LC50 of >0.56 mg/l was reported in rats (Mellon
Institute of Industrial Research, 1962),
The key study for acute dermal toxicity was conducted according to a
test protocol that is comparable to OECD Test Guideline 402, however,
not compliant with GLP. An LD50 of 3.97 ml/ kg bw (equivalent to 4248
mg/kg bw) was reported. Furthermore, deaths occurred on the first and
second days after application. Additionally, no clinical signs were
reported. Moreover, all survivors gained weight during the observation
period. Necropsy findings included congested lungs, mottled livers with
prominent acini, and off-colour kidneys with internal congestion
Based on studies for the oral, inhalation and dermal routes, no
classification is required for the acute toxicity of
[3-(2,3-epoxypropoxy)propyl]trimethoxysilane, in accordance with current
Regulation (EC) No. 1272/2008.
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