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EC number: 203-468-6
CAS number: 107-15-3
reduction in parental body weight gain of female rats in the
intermediate and high dose group of the F0 generation, in the high dose
group of the F1 generation and of male rats in the high dose group of
both F0 and F1 generations.
substance-related parental deaths in the F0 or F1 generation.
decrease of absolute liver weight in male rats of the high dose F1
macroscopic or histopathologic findings except a significant higher
incidence of hepatocellular pleomorphism in both sexes of the high dose
group of the F1 generation (6/10 male, 10/10 female; control: 0/20 each)
and a significant decreased prevalence of kidney tubular mineralization
in female rats of the high dose group of the F1 generation (0/10 female;
conclusion there was no evidence of fertility impairment or embryotoxic
effect at dose levels that show maternal or paternal toxicity.
In a two-generation study, male and female
Fischer 344 rats were fed diets containing 0, 50, 150 or 500 mg/kg bw/day
of EDA*2HCl. At each dose level 13 male and 26 female rats were mated in
both F0 and F1 generation. In the high dose group effects noted were
decreased body weight gain in both F0 and F1 generations, a higher
incidence of hepatocellular pleomorphism in F1 generation, and decreased
liver weights in male rats in F1 generation. In the intermediate dose
group female rats of F0 generation showed a decreased body weight gain.
No evidence of impaired fertility or embryotoxicity was seen at any dose
level. NOAEL parental toxicity was 50 mg/kg bw/day (23 mg/kg bw/day
calculated as Ethylenediamine base), NOAEL reproductive performance at least
500 mg/kg bw/day (227 mg/kg bw/day calculated as Ethylenediamine base)
and NOAEL F1 offspring was at least 500 mg/kg (227 mg/kg bw/day
calculated as Ethylenediamine base; highest dose tested).
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