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EC number: 220-479-1
CAS number: 2781-00-2
Fertility performance: the fertility index was 100 %, 100 %, 100 % and
70 % in groups 1, 2, 3, and 4 respectively
Tabular summary report of effects on reproduction/developpemnt
The potential toxic effects of 2,2-Bis(t-butylperoxy isopropyl) benzene
on male and female reproductive performance, such as gonadal function,
mating behavior, conception, development of the conceptus and
parturition was evaluated in a combined repeated dose and
reproduction/developmental screening study according to the OECD
Guideline No. 422.
Four groups of Sprague Dawley rats (10 males and 10 females) were
treated orally with 2,2-Bis(t-butylperoxy isopropyl)benzene at 0, 100,
300, 1000 mg/kg/d by gavage.
Mortality and clinical signs were checked daily. Body weight and food
consumption were recorded at regular intervals. Females were paired with
males from the same dose-level group until mating occurred. Gestation
was monitored. Females were allowed to deliver normally and to rear
their progeny until day 4 post-partum. During the lactation period, the
pups were examined daily for survival, external abnormalities and
clinical signs. Their body weights were recorded on days 1 and 4
post-partum. At final sacrifice, the pups were examined for gross
external abnormalities and then discarded. At final sacrifice of the
parent, the testis and epididymides were weighed for the males and a
complete macroscopic post-mortem examination was performed for both
gender. A microscopic examination was performed on the ovaries, testes
and epididymides of females and males, respectively.
At any dose level, no test item-related effect was observed on the
mortality rate, the clinical signs and behavior in parental generation,
the body weight gain and the food consumption. . All male and female
animals in groups 2, 3, and 4 were noted without any test item related
finding at necropsy.
The mean body weight
of pups per group was statistically significantly reduced on day 4 post
Mean kidneys weights were statistically significantly increased at 1000
mg/kg for male and female. Kidney / body weight ratio were increased at
300 and 1000 mg/kg. These findings may be due to an increased metabolism
and excretion of the test item and were therefore considered test item
Treatment at 1000 mg/kg was associated with continuing body weight
decrease during the study.
Treatment with 1000 mg/kg was associated with a smaller number of
pregnant dams that were noted with less corpora lutea, less implantation
sites, less live embryos at first litter check, and a higher postnatal
loss. The living pups at 1000 mg/kg and at 300 mg/kg were noted with
less body weight gain until day 4 post partum. The litter weight gain at
day 4 post partum was reduced.
Moreover treatment at 1000 mg/kg/day was associated in kidneys with a
diffuse tubular degeneration / regeneration in all males. A multifocal
tubular degeneration / regeneration was observed in some males at 300
mg/kg and some females at 1000 mg/kg. A slightly increased incidence of
focal tubular degeneration / regeneration was noted in the females at
1000 mg/kg. A slightly increased incidence and severity of hyaline
droplets in proximal convoluted tubules was noted in males at 1000 and
No effects were noted for the parameters on clinical laboratory
investigations, or for other macroscopic findings during scheduled
Based on these data, it can be concluded that the No Observed Adverse
Effect Level (NOAEL) was 100 mg/kg body weight/day (based both on
parental and foetal toxicity).
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