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EC number: 245-659-7
CAS number: 23432-62-4
RDT oral (OECD 408): NOAEL = 100 mg/kg bw/day for females; NOAEL for
males could not be established
RDT inhalation: no data available
RDT dermal: no data available
One subchronic repeated
dose toxicity study on methyl-N-[3-(trimethoxysilyl)propyl]carbamate
(CAS 23432-62-4) is available.
In a repeated dose
toxicity study that adhered to OECD 408 test guideline and was GLP
compliant, the test material was administered daily to 4 dose groups for
90 days. Dose groups consisted of a control group administered corn oil,
a low-dose group administered 100 mg/kg bw/day, a mid-dose group
administered 300 mg/kg bw/day, and a high-dose group administered 1000
mg/kg bw/day. The four groups comprised of 10 male and 10 female Wistar
rats. In addition, animals in a recovery group were observed for a
period of 28 days following the last administration (high dose and
control groups only, each group consisting of 5 male and 5 female Wistar
mortality was found for one male animal in the high-dose recovery group
(1000 mg/kg bw/day). The cause of death was associated with presence of
precipitates within the ureteral lumen leading to an obstructive
nephropathy, a subsequent severe acute urinary bladder dilatation,
marked hydronephrosis and severe secondary metastatic calcification due
to renal failure and hypercalcaemia in multiple organs.
No adverse effects of
test item were found on male and female clinical observations,
functional observations, body weight development, food consumption,
thyroid hormone analysis, sperm parameters, haematology, coagulation,
and clinical biochemistry and organ weights.
lesions in the lower urinary tract were found in males at ≥ 100 mg/kg
bw/day and females at ≥ 300 mg/kg bw/day in the main test and recovery
groups, associated with urolithiasis.
The main induced
findings in the urinary system were urothelial hyperplasia of the lower
urinary tract (renal pelvis, urinary bladder, ureter and/or urethra) in
males at ≥ 100 mg/kg bw/day and females at ≥ 300 mg/kg bw/day,
precipitates in the urine in males at ≥ 100 mg/kg bw/day and females at
≥ 300 mg/kg bw/day, hyaline droplets in the renal cortex of males at ≥
100 mg/kg bw/day and lipid-laden cell accumulations were detected within
the renal medulla or bladder submucosa from both genders at 1000 mg/kg
bw/day. The changes in the urinary tract correlate to macroscopic
findings at necropsy (granular sticky, yellow abnormal content in the
Thymic atrophy in males
at ≥ 100 mg/kg bw/day was considered mainly a stress-related finding,
indirectly linked to the treatment with the test item and associated
with an organ weight decrease compared to control group. No
morphological toxicologically relevant effects in the reproductive
organs were found.
The no observed adverse
effect level (NOAEL) of methyl [3-(trimethoxysilyl)propyl]carbamate (CAS
23432-62-4) in this study is considered to be at 100 mg/kg bw/day in
females; the NOAEL for males could not be established.
The available data on
methyl-N-[3 (trimethoxysilyl)propyl]carbamate meet the criteria for
classification according to Regulation (EC) 1272/2008, and therefore the
substance is classified as STOT RE2.
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