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EC number: 480-890-9 | CAS number: 906532-68-1
Up to 1000 mg/kg/day oral administration of Everzol Orange ED-G Crude, no adverse effects were observed at rats prior to mating, during the mating, post-mating, gestation and lactation.
The study was conducted to evaluate the potential effects of the test article “Everzol Orange ED-G Crude” on the reproduction of Sprague-Dawley (SD) rats via oral administration.
The animals were randomized into four groups consisting of 10 males and 10 females each group. The animals at age of 8 to 9 weeks were used for starting dosing and at 11 weeks old used for mating. Groups of 20 SD rats received single oral doses of 0, 100, 300 or 1000 mg/kg/day test article. Following parameters were assessed: body weight and food consumption, mating behavior; fertility index; gestation length; uterus examination; pups examination including number, sex, live birth , litter weights and gross abnormalities; necropsy examination and specific organs histopathology examination.
During the study period, no mortalities were observed in male and female rats dosed with Everzol Orange ED-G Crude at 100, 300 or 1000 mg/kg/day. There were no test article treatment-related changes in clinical observation, body weight, food consumption, mating, behavior, fertility index and gestation length. No toxic effects on reproduction, offspring and post-natal growth. No macro- and microscopic findings in testes and epididymides of males, as well as ovaries of females.
Based on the experimental results, Everzol Orange ED-G Crude does not have to be classified in reproduction according to CLP (EC1272/2008)and DSD (67/548/EEC).
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