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EC number: 201-152-2
CAS number: 78-87-5
Analysis of dosing solutions and received dose Mean exposure
concentrations (determined on 3-4 occasions and presented as percent
nominal with SD in parentheses) for the low, mid and high dose groups
were as follows:
f0 males: 88.8 (6.1), 98.2 (7.3), 100.0 (8.2)
f0 females: 90.3 (6.9), 100.4 (4.3), 102.4 (8.4)
f1 males: 100.7 (29.0), 96.0 (0.9), 95.3 (2.2)
f1 females: 94.6 (21.8), 97.7 (2.6), 96.1 (3.1)
Female Bwts (pre-breed)
Water Consumption (M + F)
Gestation Bwt Gain
Gestation Water Consumption
Gestation Feed Consumption
Lactation Bwt Gains
Lactation Water Consumption
Lactation Feed Consumption
Received dose Based upon mean body weight and water consumption data,
males of both generations from the low, mid and high dose groups
received approx. 20 - 30, 70 - 130 and 130 - 250 mg/kg bwt/d. Equivalent
female groups received 30 - 40, 110 - 140 and 190 - 270 mg/kg bwt/d.
Female water consumption increased during lactation, with received doses
of approx 60, 200 450-500 mg/kg bwt/d.
Received dose (mg/kg bwt/day)
* Note: greater exposure reflects increased water consumption during
In life observations
No treatment-related clinical signs were observed.
There were relatively minor and sporadic effects on food intake. f0
females from the high and low dose groups consumed 10% and 6% less than
the controls, while f1 males from the high dose group showed an overall
8% reduction in food consumption (pre-mating and mating phases). Food
intake data for the other groups were generally unremarkable.
A dose-related decrease in water consumption was apparent in animals
from both the f0 and f1 generations, presumably reflecting reduced
palatability in the mid and high dose groups. Overall, water consumption
in high dose males and pregnant females was 50-60% of control, and 70%
of control in lactating females. Water intake in mid dose males and mid
dose pregnant females was 70 - 80% of control, and 75 - 85% of control
consumption in mid dose lactating females. Results for the low dose
animals were 90 - 104% of control. NOTE: Water consumption typically
increases from around gestation day 13 in order to compensate for
increased plasma and extracellular fluid volumes during the late stages
of pregnancy. This was not the case in this study, due to the
unacceptable palatability of the drinking water. This would be expected
to have an adverse influence on fetal development. It is also pertinent
that water consumption in untreated (control) females increased in this
study during lactation, whereas major reductions were apparent in
treated animals during lactation. This would be expected to have
impacted post-natal survival of the pups.
Parental body weight
Body weights for the high dose animals were significantly (alpha = 0.05)
lower than control in f0 and f1 generations of both sexes. In terms of
affecting reproductive outcomes, effects in females appeared
particularly important. Thus body weights for high dose f0 and f1
females were 5% and 11% lower than control during the pre-mating period,
with a 10 - 12% decrement present during gestation and an approx. 15%
reduction during lactation. Gestation body weight gains were decreased
by approx. 20% in f0 and f1 females given 0.24% PDC, and by 7-13% in
females given 0.1% PDC. Less consistent body weight decrements were
noted in the mid dose animals, with negligible effects in the low dose
There were no significant or obvious treatment-related differences in
male or female reproductive performance, as assessed from mating- and
conception indices, fertility or gestational period. Sporadic
differences seen for some female parameters were not dose-related (ie
present in low and/or mid but not high dose animals) or were within the
range of historic control data. All females produced viable litters.
Sporadic hematological changes noted in this study were not dose related
and inconsistently expressed in males and females of the same generation
and in same sex animals of different generations. Overall these effects
appeared incidental and unrelated to treatment with PDC.
Increased relative kidney weight values in high dose animals (both
sexes) appeared secondary to a lower terminal body weight. No gross
pathological changes were noted in any of the parental animals.
Treatment-related histologic changes were limited to increased
hepatocellular granularity (adaptive change) in males and females of
both generations at all dose levels. Although no statistical analyses
are reported, the incidence in high dose females (17% and 10% for f0 and
f1, resectively) and high dose f1 males (13%) appears greater than
control (0 - 2% for all sex/generation groups). The response in f1 high
dose males (5% incidence) and mid and low dose animals of the other
generations were less pronounced (2 - 8% incidence) and/or not dose
related. All other tissues, including reproductive organs from both
sexes, were unremarkable.
There were no significant treatment-related external observations or
difference in sex ratio in either generation. The number of pups born
alive was similar in the control and test groups from both phases of the
study, however postnatal survival in high dose f1 litters was
significantly lower than control while that of the high dose f2 litters
was 10% lower than controls on PND 14 and 21; these effects appeared
treatment-related. Bodyweights for high dose f0 neonates were
significantly decreased, with day 21 values approx. 15% lower than
control. Bodyweights of f1 litters were less severely affected (4 - 7%
reduction), and attained significance only on lactation day 21.
An increased hemoglobin concentration in high dose f1 males and an
increased mean relative kidney weight in high dose f1 females appeared
related to a lowered water intake and body weight, respectively. All
other hematological and gross necropsy observations were comparable to
control in both the f1 and the f2 generations.
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