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EC number: 425-050-4 | CAS number: 10217-34-2
Analysis of the accuracy of dose preparations revealed overall mean values of 102% of nominal.
100 mg/kg/day: No treatment-related findings noted
500 mg/kg/day: After 13 weeks, partial thromboplastin time was slightly increased in females.
1000 mg/kg/day: After 13 weeks, red blood cell count and haematocrit were slightly decreased, and mean corpuscular haemoglobin concentration and partial thromboplastin time were slightly increased in females. After 13 weeks, urea was slightly increased in males.
This study was designed to evaluate the oral toxicity of Silane, triethoxy[2-(7-oxabicyclo[4.1.0]hept-3yl)ethyl]- when administered once daily by oral gavage to rats for at least 90 consecutive days. The substance was administered in polyethylene glycol (PEG 400) at 100, 500 and 1000 mg/kg/day. Control animals received PEG 400 at dose volumes equivalent to those administered to treatment group animals.
Mortality was seen in the control group (2 males) and the 500 mg/kg dose group (1 male). During pretest, one of the control males showed already a slightly reduced health status based on low body weight gain and food consumption. In addition, no mortality occurred at the highest dose tested and no definitive cause of dead could be determined from microscopic examination. Therefore, these deaths were considered to have occurred by chance or due to technical reasons (e.g. gavage related injury) and not related to treatment with the test substance.
Changes in red blood cell count and associated parameters were noted in females of the 1000 mg/kg dose group after 30 days and 13 weeks of treatment. The changes seen after 30 days (including white blood cell count) are thought to have resulted from slightly high control values and not to be a clear sign of toxicity. This is in accordance with the absence of treatment-related effects at 1000 mg/kg after 28 days in a previous study (NOTOX Project 194996, registered in IUCLID for Silane, triethoxy[2-(7-oxabicyclo[4.1.0]hept-3yl)ethyl]- on 7.5.1 Repeated dose toxicity: oral 28 days). All haematological changes noted after 13 weeks (including partial thromboplastin time) were only slight in nature and not accompanied by any evidence of organ dysfunction at macroscopic or microscopic level.
Slightly increased serum urea levels were recorded in males of the 1000 mg/kg dose group at pretest and after 13 weeks of treatment. Levels at the end of treatment were only slightly higher than pretest levels, and therefore the effect of treatment is considered minimal. This is supported by the absence of any evidence of organ impairment.
The only change noted below a dose of 1000 mg/kg was an increase in partial thromboplastin time at 500 mg/kg, but in the absence of other relevant findings, a connection with treatment is considered unlikely.
In conclusion, treatment with Silane, triethoxy[2-(7-oxabicyclo[4.1.0]hept-3yl)ethyl]- for at least 90 days produced only some minimal changes which were no accompanied by any evidence of organ dysfunction. Based on these results, a NOAEL of 1000 mg/kg/day was concluded.
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