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EC number: 204-881-4
CAS number: 128-37-0
Maternal toxicity, indicated by a significant increase of the liver
weight was seen at 500 mg/kg body weight and day.
There were no differences in mating sucess. Pregnancy proceeded normally
in all groups. There was no alteration in numbers of resoption sites. No
statistically significant change was seen in the number of foetuses/dam.
The number of pups per litter did not differ. There was a trend to an
increase in the number of pups found dead or dying soon after birth with
increase in dose but the actual number of death in affected litters was
not influenced by treatment with BHT. The total litter weight was
significantly decreased for dams treated with the high dose of BHT. The
weight gain of pups from dams receiving the highest dose of BHT was
consistently less than that of control pups or pups of dams receiving
lower dose of BHT. The development was retarded in the high dose group.
The pathology findings (F0 and F1, including liver-biochemistry, organ
weights, gross and microscopic evaluation are presented in chapter
"Repeated Dose Toxicology and Carcinogenicity".
The NOAEL for toxicity to reproduction was assumed to be 500 mg/kg body
weight and day; the NOAEL for maternal toxicity was assumed to be 100
mg/kg body weight and day.
The results of this two-generation carcinogenicity study revealed no
adverse effects on reproductive performance of the F0 generation fed
with BHT at dietary levels of 25, 100 or 500 mg/kg body weight. Maternal
toxicity, indicated by a significant increase of the liver weight was
seen at 500 mg/kg body weight and day. No differences in mating success
were found in treated dams compared to control. In addition, pregnancy
proceeded normally in all groups. There was no alteration in numbers of
resorption sites and no statistically significant change was seen in the
number of fetuses per dam. The number of pups per litter did not differ
According to the findings of this study, no adverse effects on
reproduction were found. The NOAEL for toxicity to reproduction was
assumed to be 500 mg/kg body weight and day; the NOAEL for maternal
toxicity was assumed to be 100 mg/kg body weight and day.
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