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EC number: 248-654-8
CAS number: 27776-01-8
In this prenatal developmental toxicity study, the test item Benzyltoluene
was administered orally to female rats at dose levels
of 30,100or300 mg/kg b.w./day from the 6th to 20th
day of pregnancy.
Under the present test conditions, the
no-observed-adverse-effect level (NOAEL) was 100 mg Benzyltoluene/kg
b.w./day for the dams.
Treatment with 300 mg Benzyltoluene/kg b.w./day caused
salivation and increased intake of drinking water on a few or individual
test days as well as reductions in the body weight, the body weight gain
and the food consumption.
A few dams with gastric changes (haemorrhagic focus/foci, thin
walls) were noted at the high dose level during the macroscopic
inspection at necropsy.
The no-observed-adverse-effect level (NOAEL) for
the fetal organism was 100 mg Benzyltoluene/kg b.w./day.
At the materno-toxic dose of 300 mg Benzyltoluene/kg b.w./day,
pronounced decreases were noted for fetal body weights (by approx. 26%)
and placental weights (by approx. 14%).
At 300 mg Benzyltoluene/kg b.w./day, an increased
incidence was noted for retarded skeletal ossification (sternum, caudal
vertebral bodies, metacarpalia and metatarsalia). These changes are
regarded to be a secondary effect related to the maternal toxicity
(Carney and Kimmel, 2007).
In addition, an increased incidence was noted for slight soft
tissue variations of the kidney (uni-
or bilateral dilatation of renal pelvis) and the 4th cerebral ventricle
(dilatation). According to the ECETOC guidance document ("Identification
and assessment of the effects of chemicals on reproduction and
development (Reproductive Toxicology)", Monograph No. 5, December 1983) these
effects are regarded to represent a 'low level of concern'. Considering
the maternal and fetal toxicity at the high dose level the final
conclusion according to the ECETOC guidance document for these findings
is 'no concern'. No test item-related malformation was noted at any of
the test item treated groups. There was no test item-related increase in
the incidence of fetal external / internal or skeletal variations at any
tested dose level.
Under the conditions of the study, Benzyltoluene did not show any
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