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EC number: 305-795-0
CAS number: 95009-65-7
This is a repeat dose toxicity study
conducted according to guideline protocol with the objective of
providing initial information on possible effects on reproduction and
/or development in rats. Rosin, fumarated was administered in the diet
of rats at concentrations of 0 ppm, 1000 ppm (males 72 -89 mg/kg bw/d;
females 79 -108 mg/kg bw/d); 3000 ppm (males 221 -288 mg/kg bw/d;
females 196 -292 mg/kg bw/d; and 10000 ppm (males 651 -889 mg/kg bw/d;
females (449 -995 mg/kg bw/d). The males were treated for 2 weeks prior
to mating through to sacrifice after 4 weeks treatment. The females were
treated for 2 weeks prior to mating then through mating, gestation and
until termination on at least day 4 of lactation. Under the conditions
of this study, parental toxicity was exhibited at levels of 3000 and
10000 ppm, with a decrease in mean body weight at both doses and sexes,
an increase in total bilirubin in both sexes at 10000 ppm and a decrease
in adrenal gland weight in females at 10000 ppm, but there were no clear
toxic effects at 1000 ppm. Therefore the parental NOEL was considered to
be 1000 ppm (males 72 -97 mg/kg bw/d; females 79 -108 mg/kg bw/d). For
reproductive parameters the NOEL was considered to be 3000 ppm (males
221 -288 mg/kg bw/d; females 196 -268 mg/kg bw/d).
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