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EC number: 204-427-5
CAS number: 120-80-9
Reproduction and breeding data: Summary of
Number of females, which died before the
scheduled necropsy (A)
Number of females paired
Number of females mated (B)
Number of pregnant females
Number of females which did not
deliver any pups (C)
Number of females, which lost their litters (D)
Number of females which reared their pups until day 4 post partum
(A) = Female No. 71
died spontaneously on day 14 of the pre-pairing period
(B) = Female Nos. 45 and48
ingroup 1 did
not mate and were not pregnant (no corpora lutea and no implantation
sites were noted)
(C) = Female no.61
ingroup 3 had no
mating noted but was pregnant (implantation sites noted at necropsy)
(D) = Female No. 77
lost its litter (two pups) on day 2 post partum
The purpose of this study (OECD 422, Harlan
2009) was to generate information concerning the effects of Catechol on
the possible health hazards likely to arise from repeated exposure over
a relatively limited period of time. In addition it provides information
on possible effects on male and female reproductive performance such as
gonadal function, mating behavior, conception, development of the
conceptus and parturition.
Catechol was administered to male rats for
at least 28 days and to female rats for 14 days prior to pairing,
through the pairing and gestation periods until the F1 generation
reached day 4 post partum.
The following dose levels were applied:
Group 1: 0 mg/kg body weight/day (control
Group 2: 30 mg/kg body weight/day
Group 3: 80 mg/kg body weight/day
Group 4: 160 mg/kg body weight/day
A standard dose volume of 10 mL/kg body
weight with a daily adjustment to the actual body weight was used.
Control animals were dosed with the vehicle alone (distilled water).
The following results were obtained:
In parent animals, in males and females,
body weight and body weight gain were not considered to be affected by
the treatment with the test item.
At 160 mg/kg/day, liver weights were
statistically significantly increased in males and females. This was
considered to be of metabolic nature since only hepatocellular
hypertrophy and no liver injury was recorded during the
At 80 and 160 mg/kg/day, incidence and
severity of squamous hyperplasia in the stomach were increased in
animals of both sexes. This lesion represents a localized stomach
reaction to a repeatedly gavages irritant test material.
In pups, the mean number of pups at first
litter check and on day 4 post partum was not affected by the treatment
with the test item. The sex ratio was also not affected, and weight
development was not affected by the treatment with the test item. At
necropsy of pups, no test item-related findings were noted.
Based on the findings noted at
histopathological examination the general NOEL (No Observed
Effect Level) was considered to be 30 mg/kg/day, due to the
squamous hyperplasia in the stomach.
The NOEL for reproduction/developmental
toxicity was considered to be 160 mg/kg/day, the highest dose
tested without observed effect.
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