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EC number: 225-805-6
CAS number: 5089-70-3
No reliable repeated-dose toxicity data are available for (3-chloropropyl)triethoxysilane, therefore good quality data for the analogous substance (3-chloropropyl)trimethoxysilane have been read-across.In a 90-day inhalation study (DCC, 1993) in rats, conducted in accordance with OECD 413, the NOAEC was determined to be 100 ppm (813 mg/m3). (3-Chloropropyl)trimethoxysilane was tested in an inhalation OECD 422 study (RCC, 2005), whole-body in rats, up to and including the highest concentration of 100 ppm. In this study there were no signs of general toxicity. Therefore based on these results the NOAEC was established to be at least 100 ppm (813 mg/m3). A repeated application study via the dermal route is available for (3-chloropropyl)triethoxysilane. However, the purpose of this test was to determine irritation effects following repeated exposures, and did not meet the requirements for a repeated dose toxicity test.
There are two reliability score 1 studies for repeated inhalation
of (3-chloropropyl)trimethoxysilane. The 90-day study was selected as
the key study as it tested over the longest duration.
In the key 90-day inhalation study, microscopic examinations did
not reveal any adverse findings in females exposed to 0.5 or 5 ppm.
Eight of 10 male animals in the 0.5 ppm exposure group were reported as
normal. The two remaining male animals exhibited minimal chronic
cystitis of the urinary bladder. Nine of 10 male animals were reported
as normal in the 5.0 ppm exposure group. The remaining male animals
exhibited minimal chronic cystitis of the urinary bladder.
Treatment-related histopathological effects were observed in the 100 ppm
group animals. Increased incidence of hyperplasia of the urinary bladder
epithelium was noted in both sexes of this group.
It is not known whether the urinary bladder was inflated by a
fixative before microscopic examination. Without inflation of the
urinary bladder the relevance of the hyperplasia is questionable. Based
onthe fact that the hyperplasia of the
bladder was mild /minimal and in some cases associated with a minimal
inflammation (cystitis) it can presumed that if the stimulus for the
hyperplastic changes is removed the hyperplasia will resolve within a
matter of weeks and the urinary bladder will return to a normal
histologic appearance.A minimal/mild change of the urinary
bladder not associated with any clinical symptoms or changes in urine
parameters does not reflect a marked organ dysfunction. Therefore, the
mild/minimal hyperplastic effects are not considered as adverse and the
NOAEC is 100 ppm(813 mg/m3).
Based on read-across from 3-chloropropyl(trimethoxysilane), there is no
proposal to classify
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