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EC number: 202-338-6
CAS number: 94-49-5
Wistar Han rats were treated with
Ethylene glycol dibenzoate by daily oral gavage at dose levels of 100,
300 and 1000 mg/kg (10 rats/sex/dose level). Concurrent controls (10
rats/sex) received the vehicle, polyethylene glycol 400, alone. Males
were treated for 8 weeks prior to mating, during mating, and up to
termination (for 92 days). Females that delivered offspring were treated
for 8 weeks prior to mating, during mating, duringpost-coitum, and 14-15
days of lactation (for 93-98 days). Females without offspring were
treated for 85 days (two non-pregnant females) or 96 days (one female
without evidence of mating).
Formulation analysis showed that the
formulations were prepared accurately and homogeneously.
There were no effects on mortality,
clinical signs or BW (in males the control BW were from the start
slightly higher than that of the three dosed groups other groups).
Haematological evaluations showed no
treatment related effect.
Clinical biochemistry an increase only
in males at 1000 mg in ASAT, ALT and bilirubin, which all remained
within historical control ranges, and of albumin and cholesterol which
were slightly out of these ranges.
Thyroid hormones showed statistically
significantly changes. In males. TSH showed a non-dose-response related
increase at 300 mg/kg, caused by 2 males, and is not considered
toxicologically relevant. T4 is decreased at 1000 mg/kg compared to
control (males 57%↓; Females 19%↓).
Noteworthy is that the T4 levels in
pups that were also evaluated at the end of the study, showed no effects.
pathology and organ weights showed no relevant findings
histopathological examination, the thyroid showed an increased incidence
of follicular cell hypertrophy at 1000 mg/kg in females (up to
slight). This was considered as not toxicological important as the
effects are minimal with maximum levels that are also observed in
control. Besides, in males no such increased incidence of follicular
cell hypertrophy was observed, although the hormone changes are more
pronounced than in the females.
Although the effects were not
consistent, unaccompanied by treatment related changes in thyroid weight
or morphology, and no corroborative findings were observed in TSH
levels, adversity could not be excluded.
A further treatment-related
morphological change observed in females treated at 1000 mg/kg consisted
of an increased incidence of minimal hyperplasia/hypertrophy of the
urothelium of the urinary bladder. There was no inflammation or cell
death involved in this process. Therefore, this minimal change was
considered as non-adverse. (Palazziet
Exposure to the test item up to
1000 mg/kg was not associated with obvious toxicity in the remaining
parental parameters examined in this study (i.e. functional tests,
Based on decreased T4 levels (for
females in combination with increased incidence of follicular cell
hypertrophy in the thyroid) at 1000 mg/kg, of which adversity could not
be excluded, a NOAEL of 300 mg/kg bw/day is derived for parental
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