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EC number: 220-120-9 | CAS number: 2634-33-5
A study was conducted to determine the sub-chronic repeat dose toxicity of the substance according to US EPA Guideline OPP 82 -1. Groups of twelve male and twelve female Alpk:APfSD rats were fed diets containing 0, 200, 900 or 4000 ppm of the test substance for a period of 90 days. The food consumption and bodyweight were monitored throughout the study and the average dose received by the animals in the 200, 900 and 4000 ppm groups was calculated as 15.3, 69.0 and 322.0 mg/kg/day for males, and 17.6, 78.3 and 356.3 mg/kg/day for females, respectively. During the study the rats were observed daily for changes in clinical conditions and behaviour and once weekly a detailed examination of each rat was performed. An ophthalmoscopic examination of all animals in the control and 4000 ppm was performed prior to the start of the study and then during the week prior to termination. After 90 days of treatment all surviving animals were sacrificed and blood samples taken for haematological and clinical biochemistry examination. A full macroscopic examination was performed on all animals and the adrenal glands, kidneys, liver, brain and testes were weighed. Microscopic examination was performed on liver, kidney, lung and stomach samples from all animals and on all processed tissues from the control and 4000 ppm dose group. There were no mortalities, all animals were observed to be in good clinical condition and any clinical signs recorded were considered to be of a type and incidence commonly seen in rats of this age and strain and therefore not considered to be treatment-related. The bodyweights of animals at the high dose were statistically significantly reduced throughout the study and a corresponding decrease in food consumption in the females of the high dose group. There was no effect on bodyweight at any other dose level. There were no observations in the haematology determinations considered to be treatment-related. A statistically significant increase in plasma alkaline phosphatase activity of males at high dose and statistically significant increases in plasma cholesterol levels of females at mid and high doses were observed. No macroscopic abnormalities were observed during necropsy of the test animals. The only macroscopic finding attributed to treatment was a thickened limiting ridge in the stomach of majority of the animals at high dose, which corresponded to the presence of a minimal, slight or moderate hyperplasia of the forestomach adjacent to the limiting ridge. A mixed inflammatory cell submucosal infiltrate accompanied the hyperplastic change in two males and six females. Based on the reduction in body weight and food consumption at the high dose, the sub-chronic systemic NOAEL of the substance in rats was determined to be 900 ppm (69.0 mg/kg/day in males and 78.3 mg/kg/day in females) (Whiles, 1991).
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