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EC number: 260-828-5
CAS number: 57583-34-3
NOAEL: Based on the changes in neurobehavioural parameters, haematology, clinical chemistry, urinalysis and organ weights and the associated
histopathological findings in thymus and brain in animals of the 750 mg/kg group, the NOAEL in the sub-chronic toxicity study was placed at 150 mg trichloromethylstannane/kg diet (equivalent to 9.8 mg trichloromethylstannane/kg bw/day in males and 10.2 mg trichloromethylstannane/kg bw/day in females).
Dietary doses of 50, 250, 750, and 1500 mg trichloromethylstannane/kg feed (ppm) were administered for 14 days. No treatment-related clinical signs were observed. The body weights were sporadically decreased in males of the 750 mg/kg group and throughout at 1500 mg/kg. Body weights were not significantly different among females. Food consumption was significantly decreased in males of the 750 and 1500 mg/kg groups on day 7 and 14. Food consumption was significantly increased in females of the 50 and 250 mg/kg groups (day 7) and significantly decreased in females of the 750 mg/kg group (days 7 and 14) and the 1500 mg/kg group (day 7). Food conversion efficiency was significantly decreased in males of the 1500 mg/kg group (days 7 and 14). Food conversion efficiency was not significantly different among females. The absolute weights of the testes were significantly decreased in the males of the 50 and 1500 mg/kg groups. Absolute spleen weights, relative kidney weights and absolute and relative liver weights were significantly decreased in the males of the 1500 mg/kg group. Absolute weights of the ovaries were significantly increased in the females of the 250 mg/kg group and decreased in the females of the 1500 mg/kg group. Absolute and relative spleen weights were significantly decreased in females of the 750 and 1500 mg/kg groups. Macroscopic examination at necropsy did not reveal any treatment related changes.
Dietary exposure of trichloromethylstannane up to 1500 mg/kg for 14 days was tolerated; however, the body weight and food consumption decreases were deemed palatability effects at 750 and 1500 mg/kg. The low food intake, low food efficiency, and organ weight effects at these doses were suggestive of a toxic response threshold. Doses for the main and satellite studies were chosen as 30, 150, and 750 mg/kg in the diet.
of trichloromethylstannane in Wistar rats was examined using continuous
administration via the diet for 13 consecutive weeks (OECD Test
Guideline 408). In satellite groups of female rats a
reproduction/developmental screening test (OECD Test Guideline 421) was
performed to provide initial data on possible reproductive and
developmental effects of trichloromethylstannane. The main study used
four groups of 10 rats/sex (13-week study) and the satellite study used
four groups of 10 female rats (reproduction/developmental screening
study). For both studies, the control group was kept on control diet and
three test groups received experimental diets containing 30,150 and 750
mg/kg [ppm] of the test substance. The dose levels used in both studies
were based on the results of a preceding dose range finding study.
observations, growth, food consumption, food conversion efficiency,
neurobehavioural testing, ophthalmoscopy, haematology, clinical
chemistry, renal concentration test, urinalysis, organ weights and gross
examination at necropsy, microscopic examination of various organs and
tissues and assessment of various reproductive and developmental
parameters were used as criteria for detecting the effects of treatment.
study (OECD Test Guideline 408)
calculated doses for the groups receiving 30, 150, or 750 mg/kg
trichloromethylstannane in the diet were 1.9,9.8, and 49.7 mg/kg body
weight/day in males and 2.1, 10.2, and 53.6 mg/kg body weight/day in
treatment-related changes were observed in clinical signs, body weight,
food conversion efficiency and ophthalmoscopy.
A number of
haematological changes (statistically significant increases in RBC, Hb,
PCV, MCV and MCH and decreases in thrombocytes, prothrombin time and
eosinophilic leucocytes) observed in the 750 mg/kg group, were
considered treatment-related and toxicologically relevant.
A number of
clinical chemistry parameters (statistically significant increases in
ALP, ASAT, albumin, urea, creatinin, cholesterol, phospholipids and
chloride and a decreases in potassium) observed in the 750 mg/kg group,
were considered treatment-related and toxicologically relevant.
in urinary volume and density and in urinary pH and crystals observed in
the 750 mg/kg group, were considered treatment-related and
in organ weights (increases in adrenal and kidney weights and decreases
in thymus, brain, spleen and epidydimidal weights) observed in the 750
mg/kg group were considered treatment-related and toxicologically
in thymus weights was accompanied by a decrease in cortex/medulla ratio
in the thymus of males and females, which was considered
treatment-related and toxicologically relevant.
treatment-related changes in neurobehavioural paran1eters (increased
forelimb gripstrength, increased landing footsplay, increased body
temperature and increased hyperactivity) are indicative of a neurotoxic
potential of trichloromethylstannane. The neurobehavioural changes were
corroborated by the treatment-related histopathological changes in the
brain of most animals of the 750 mg/kg group. The observed
histopathological lesion (loss of perikarya in the pyramidal layer of
the Hippocampus CAl/2) was located in a functional domain that is
generally consistent with the observed neurobehavioural changes and
provides further evidence of the neurotoxic potential of the test
substance at the 750 mg/kg level.
studv (OECD Test Guideline 408)
Based on the
changes in neurobehavioural parameters, haematology, clinical chemistry,
urinalysis, organ weights and the associated histopathological findings
in thymus and the brain in animals of the 750 mg/kg group, the No
Observed Adverse Effect Level (NOAEL) in the sub-chronic toxicity study
was placed at 150 mg Trichloromethylstannane/kg diet. This level was
equivalent to 9.8 mg/ kg body weight/day in males and 10.2 mg/kg body
weight/day for females.
Based on the
effects on body weight and food consumption in the 750 mg/kg group, 150
kg diet (equivalent to 6.2-11.7 mg/kg body weight/day) can be considered
as a NOAEL for maternal toxicity.
for general sub-chronic toxicity and maternal toxicity, fertility and
developmental effects was placed at 150 mg trichloromethylstannane per
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