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EC number: 231-887-4 | CAS number: 7775-09-9
The study was designed to investigate the effects of the test material, sodium chlorate, on the growth and reproductive performance of the Sprague-Dawley rat and complies with OECD Guideline 416. A former one-generation dose-range finding study was performed to select dose-levels for this two-generation study. The study followed the principles of GLP. The test material was administered orally, by gavage. In the P generation three groups of 25 male and 25 female rats received the test material 10 weeks before mating and during mating, pregnancy and lactation. In the F1 generation three groups of 25 male and 25 female rats received the test material at weaning, on day 22 post-partum, until weaning of the F2 generation. The dose levels were 10, 70 and 500 mg/kg/day. The control group (25 males and 25 females in both generations) received vehicle (purified water) alone.
For parent of the F0 generation, sign of toxicity was substantiated by a decrease in red blood cells and hemoglobin concentration levels at 500 mg/kg/day. For parent of the F1 generation, significantly lower body weight gain and food consumption were observed during the first week of treatment at 500 mg/kg/day. For both parent males and females of both generations given 500 mg/kg/day, signs of slight to moderate follicular hyperplasia and signs of slight to moderate hyperactivity of the thyroid glands were recorded. Signs of hyperactivity were also observed for males of both F0 and F1 generation at 70 mg/kg/day.
No effect was observed on mating, fertility, gestation, fecundity or delivery at any dose-level for either generation.
No effect was recorded on litter parameters and on pre and post-natal development of either generation at any dose-level.
Therefore, the No Observed Effect Level (NOEL) for parental toxicity is 10 mg/kg/day for the male and 70 mg/kg/day for the female. Due to an increase in spleen follicular cell hyperplasia and grade 4 follicular hyperactivity of the thyroids in males and females at 500 mg/kg bw/day in F0 and F1 parents, which is a non-adverse effects, the parental NOAEL was 70 mg/kg/day in males and females.
The No Observed Effect Level (NOEL) for mating behaviour, fertility and gestation, of each generation and for development, growth and survival of each progeny is 500 mg/kg/day.
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