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EC number: 229-419-9
CAS number: 6528-34-3
SUMMARY OF PERFORMANCE
P Animals Breeding for F1 Litters
Number of females paired
Number of females mated
Number of non pregnant females (A)
Numbers of pregnant females, which did not deliver any pups (B)
Number of females which reared their pups until day 4 post partum
(A) Female nos. 46,50, 59, 69, 83 and
(B) Female no. 87
purpose of this study was to generate preliminary information concerning
the effects of test item on 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.
test item was administered to male rats for 32 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.
following dose levels were applied:
1: 0 mg/kg body weight/day (control group)
2: 100 mg/kg body weight/day
3: 300 mg/kg body weight/day
4: 1000 mg/kg body weight/day
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 (1.0% CMC / 0.05% Tween 80 in highly purified water).
following results were obtained:
AND GENERAL TOLERABILITY OF PARENTAL ANIMALS
animals survived the scheduled study period.
the treatment, yellow stained faeces was noted in all males and females
in dose groups. This observation was due to staining properties of the
further test item-related observations were noted during clinical daily
or detailed weekly observations in males or females at any dose level.
OBSERVATIONAL BATTERY AND LOCOMOTOR ACTIVITY OF PARENTAL ANIMALS
of the parameters under investigation during the functional
observational battery gave an indication of a test item-related effect.
activity was not affected by the treatment with test item in males or
females at any dose level.
CONSUMPTION OF PARENTAL ANIMALS
effects on food consumption were noted in males or females at any dose
WEIGHT OF PARENTAL ANIMALS
males at the dose levels of 1000 and 300 mg/kg bw/day, dose dependent
and statistically significant reduction in body weight gain was noted
during the pre-pairing period. No differences in body weight gain were
noted at any dose level during the remaining study period. Body weights
of males in all dose groups were similar to the respective control
values during the entire study period. Because reduction in body weight
gain at the high- and mid-dose levels was reversible and did not cause
significant changes in body weights, this effect was considered not to
weights and body weight gain of females were not affected by the
treatment at any dose level.
LABORATORY INVESTIGATIONS IN PARENTAL ANIMALS
test item-related effects on hematology and clinical biochemistry
parameters were noted in males or females at any dose level.
changes in urine parameters were noted in males at any dose level.
AND BREEDING DATA
performance, fertility, corpora lutea count, duration of gestation,
implantation rate and post-implantation loss, litter size or postnatal
loss were not affected by the treatment with the test item.
AND SPERMATID COUNT IN PARENTAL ANIMALS
the dose level of 1000 mg/kg bw/day, reduction in mean count of
progressive sperms and increase in mean count of not motile sperms were
noted. At the dose level of 300 mg/kg bw/day, increase in mean count of
not motile sperms was noted. A significant dose dependent trend couldn't
the absence of any findings during necropsy or histopathological
examination of male reproductive organs as well as absence of any
effects on reproduction, the differences in sperm motility were
considered not to be adverse.
morphology and sperm count were not affected by the treatment at any
WEIGHTS OF PARENTAL ANIMALS
test item-related changes in organ weights were noted in males or
females at any dose level.
FINDINGS AND HISTOPATHOLOGICAL EXAMINATIONS OF PARENTAL ANIMALS
and distribution of findings noted during macroscopical examination did
not indicate any test item related effect.
findings recorded during histopathological examination were within the
range of normal background lesions which may be recorded in animals of
this strain and age.
IN PUPS AT FIRST LITTER CHECK AND DURING LACTATION
test item-related findings were noted in pups during first litter check
and during lactation at any dose level.
sex ratio was not affected by exposure to the test item at any dose
WEIGHTS TO DAY 4 POST PARTUM
Weights and body weight gain of pups were not affected by the treatment
with the test item at any dose level.
FINDINGS IN PUPS
findings were found during necropsy of pups in any dose group.
on these results, the NOAEL (No Observed Adverse Effect Level) for
general toxicity in males and females and for reproduction/developmental
toxicity was considered to be 1000 mg/kg bw/day, the highest dose level
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