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EC number: 212-110-8
CAS number: 763-32-6
Under the conditions of this screening study, 50 mg/kg bw/day was the
no-observed-adverse-effect-level (NOAEL) for males systemic toxicity and
the lowest-observed-adverse-effect-level (LOAEL) for F0 female systemic
toxicity (pregnant and lactating with more extended dosing period).
This study was designed to evaluate
the potential toxic effects of the test item Isoprenol (IPN) when
administered to rats for a minimum of 28 days and to evaluate the
potential of the test item to affect male and female reproductive
performance such as gonadal function, mating behavior, conception,
parturition, and early postnatal development.
Adverse respiratory and
cardiovascular-related clinical findings with mortality in males, lower
mean body weight gain, and/or reduced food consumption were noted in the
450 mg/kg bw/day group males and females during the treatment periods.
Microscopic findings in the heart and
lungs in the 450 mg/kg bw/day administrated males (bronchiolar
epithelial hyperplasia with a plethora of vessels, subepicardial
necrosis with mononuclear and neutrophils infiltration in the right
ventricle) correlated to the in-life clinical observations and gross
observation in dead males, considered test item-related and adverse.
Hepatocellular vacuolation (males) and angiectasis (females) findings in
the 450 mg/kg bw/day dose group correlated with a non-significant
increase in serum triglyceride and GGT in high dose male group; were
slight, not observed after the recovery period, considered non-adverse.
The subcapsular hepatocellular necrosis was noted in one female in the
50 mg/kg bw/day and female from the control recovery subgroup, which
allows considering this finding as of uncertain relationship to test
item administration in females. Atrophy of red and white pulp of spleen
with fibrosis in some males and females in the 150 and 450 mg/kg bw/day
were correlated with gross finding during necropsy, changes in organ
weight and hematology data, were considered adverse and test
item-related. Subcapsular necrosis in kidneys (one male in the 150 mg/kg
bw/day dose group) and necrosis of tubules (one female in the 50 mg/kg
bw/day dose group) correlated in males with gross observation, slight
non-significant decrease in organ weight and clinical serum chemistry,
were considered adverse and test item-related.
The observed hematological changes
were slight; however, are considered as adverse starting at the dose of
150 mg/kg bw/day. The
hematological findings in blood correlated to the changes in relative
cell count on bone marrow. ).
The direction of relative changes in the bone marrow cell lines was most
pronounced in the dose of 150 mg/kg bw/day.
No effects on FOB parameters and no
effects on locomotor activity were noted at any dose level.
The slight non-significant
prolongation of pre-coital interval was observed in the 450 mg/kg bw/day
dose group. There were no test item-related effects on other parameters
of F0 reproductive performance, gestation length, parturition, or
reproductive organs at any dosage level. Also, there were no changes in
a mean number of pups born, live litter size, and postnatal survival.
However, the body weight of newborn females (and less in males) was
reduced in the 450 mg/kg bw/day dose group; and normalized anogenital
distance was slightly non-significantly decreased in females as well as
males newborns. The slight increase in the percentage of newborn males
was noted in litters in the 150 and 450 mg/kg bw/day dose groups. The
number of F1 males with retention of areolae on PND 13 was slightly
non-significantly increased compared to the control group and historical
under the conditions of this screening study, 50 mg/kg bw/day was the
for males systemic toxicity and the lowest-observed-adverse-effect-level
(LOAEL) for F0 pregnant and lactating female with more extended dosing
The available information is conclusive and suffiecient for
classification as STOT RE 2. Classification is based mainly on effects
in haematological system and spleen.
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