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EC number: 939-379-0
CAS number: -
There were no test substance-related toxic changes in organs weights of testes, epididymis, prostate gland, seminal vesicle, vagina, cervix, uterus, ovary/oviduct. No histopathological changes were found in testes, epididymis, prostate gland, seminal vesicle, vagina, cervix, uterus, ovary/oviduct and all other examined organs.
Gelbpigment E4GN was administered by gavage to 5 male and 5 female Wistar rats per dose group in daily doses of 0, 100, 300 or 1000 mg/kg body weight for 28 days to asses its toxicity. At the end of the treatment period all animals were killed and necropsied. The pathologic evaluation consisted of organ weight, gross and microscopic examination of reproductive organs, incl. testes, epididymis, prostate gland, seminal vesicle, vagina, cervix, uterus, ovary/oviduct.
No evidence of toxicity to reproduction was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOAEL, rat: 1000 mg/kg bw/day).
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