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EC number: 220-479-1
CAS number: 2781-00-2
The potential toxic effects of 2,2-Bis(t-butylperoxy
isopropyl) benzene following repeated
oral exposure, 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. 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.
Body weights were
recorded pre-test, weekly and at death or prior necropsy. Animals were
observed daily for toxicity and pharmacological effects, and twice daily
for morbidity and mortality. A neurobehavioral examination has been
realized before the end of the study. Whole blood, serum and plasma were
sampled just prior necropsy and analysed for related haematological and
clinical chemistry parameters.
All animals were examined
for gross pathology, and organs were weighted and submitted to
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.
Treatment at 1000 mg/kg was associated with continuing
body weight decrease during the study. Mean kidneys weights were
statistically significantly increased for male and female. Kidney / body
weight ratio were increased 1000 mg/kg Moreover
treatment at 1000 mg/kg/day was associated in kidneys with a diffuse
tubular degeneration / regeneration in all males.
At 300 mg/kg/day, 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 related.
A slightly increased incidence and severity of hyaline
droplets in proximal convoluted tubules was noted in males at 1000 and
At 100 mg/kg/day, the
test item did not elicit any signs of toxicity.
Consequently, under the
experimental conditions, the No Observed Adverse Effect Level (NOAEL) is
100 mg/kg/day and the LOAEL is 300 mg/kg/day for effects on kidney
(multifocal tubular degeneration / regeneration in males, and increase
in kidney/body weight ratio)
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