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EC number: 935-411-2
CAS number: -
The objective of this study was to evaluate the potential toxicity of the test item, Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid, following daily oral administration (gavage) to rats for 13 weeks.
Four groups of ten male and ten female Sprague-Dawley rats received the test item, Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid, at dose levels of 0, 100, 300 or 1000 mg/kg/day in the vehicle (corn oil) by the oral route (gavage) once a day for 13 consecutive weeks.
The animals were checked daily for mortality and clinical signs. Detailed clinical observations were performed once a week. Body weight was recorded pre-test, on the first day of treatment and then once a week. Food consumption was recorded weekly. Ophthalmological examinations were performed on all animals before the beginning of the study and on control- and high-dose animals in Week 13. Hematology, coagulation, blood biochemistry investigations and urinalysis were performed in all animals and TSH, T3 and T4 hormone levels were determined in Week 13. On completion of the treatment period, all animals were euthanized and a full macroscopic post-mortem examination was performed. Designated organs were weighed and selected tissues were preserved. A microscopic examination was performed on designated tissues from animals in the control and high-dose groups and on all macroscopic lesions, liver and kidneys from all low- and intermediate-dose animals.
No unscheduled deaths occurred during the study. The test item was well tolerated with no relevant clinical signs and no effects on body weight, food consumption, ophthalmological, coagulation parameters or thyroid hormones.
Slightly lower red blood cell count, hemoglobin levels and hematocrit were noted in males and females at all dose levels. Slightly lower white blood cell and lymphocyte counts were observed in females at all dose levels.These slight differences were statistically significant but poorly dose-related and comparable to historical control data, and therefore were considered as non adverse.
Moderately higher total cholesterol levels, including HDL and LDL cholesterol were noted in groups treated at 300 or 1000 mg/kg/day, higher creatinine levels at 300 mg/kg/day and higher urea and creatinine levels were noted in females at 1000 mg/kg/day. In the absence of associated adverse histopathological findings,these changes were considered to be non adverse.
Test item-related increased liver weights were noted in males and/or females at 300 and 1000 mg/kg/day, and increased kidney weights in females at 1000 mg/kg/day. At gross examination, there were test item-related enlargement in the liver from one female treated at 1000 mg/kg/day that correlated with slight hepatocellular hypertrophy, and small thymus that correlated with lymphoid atrophy, in one male treated at 300 mg/kg/day and in one male treated at 1000 mg/kg/day. Test item-related microscopic observations included non adverse increased severity and incidence of tubular vacuolation and dilatation in the kidney, and hepatocellular hypertrophy in males and females treated at all dose levels.
Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid administered daily for 13 consecutive weeks by gavage to male and females Sprague-Dawley rats at dose levels of 100, 300 or 1000 mg/kg/day was clinically well tolerated and did not induce adverse clinical pathology or histopathological changes. Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was set at 1000 mg/kg/day.
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