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Disodium succinate studies in animals
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Release time：2016/3/21 16:48:20
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Males were dosed for 52 days from day 14 before mating and females were dosed from day 14 before mating to day 4 of lactation throughout the mating and pregnancy period. Hematological, blood biochemical, and histopathological examinations were performed in both sexes, and urinalysis was conducted in males.
No deaths were found in any groups. Slight loose stool was observed in one and four males at 100 and 1,000 mg/kg bw/day, respectively, and one female at 1,000 mg/kg bw/day. Salivation was found in one male and one female at 1,000 mg/kg bw/day. There were no effects of this compound on the body weight, food consumption, hematology, or blood coagulation. The blood sodium levels were higher in males at 300 and 1,000 mg/kg bw/day. The blood urea nitrogen levels were increased in females at 1,000 mg/kg bw/day. Higher levels (300 mg/dL and higher) of urinary proteins were found in one and two of the five males at 300 and 1,000 mg/kg bw/day, respectively,whereas no animals with these high levels were found in the control and 100 mg/kg bw/day groups.These findings suggest adverse effects of this compound on the kidney. Increased weight of the adrenal gland was observed in males at 1,000 mg/kg bw/day. No compound-related effects on the histopathological findings were observed. Based on the higher levels of urinary protein in males
and blood urea nitrogen in females, the NOAEL of disodium succinate hexahydrate for repeated dose toxicity was considered to be 100 mg/kg bw/day for male rats and 300 mg/kg bw/day for female rats (100 and 300 mg of disodium succinate hexahydrate are equivalent to 60 and 180 mg of disodium succinate , respectively).
Studies in Humans
There is no available information on humans.
Conclusion
In an oral repeated dose toxicity study in rats, higher levels of urinary protein in males and blood urea nitrogen in females were observed at 300 and 1,000 mg/kg bw/day, respectively. The NOAEL of disodium succinate hexahydrate for repeated dose toxicity was considered to be 100 mg/kg bw/day for male rats and 300 mg/kg bw/day for female rats (100 and 300 mg of disodium succinate hexahydrate are equivalent to 60 and 180 mg of disodium succinate , respectively).
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