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EC number: 258-753-8
CAS number: 53770-52-8
Incidence of increased salivation immediately after dosing
Dose level (mg/kg bw/day)
Body weight and body weight gain (g) during the maturation period
Statistically significant difference from control group (p> 0.05)
Statistically significant difference from control group (p> 0.01)
Food consumption (g/rat/day) during the maturation period
Water consumption (g/rat/day) during the maturation period
Statistically significant difference from control group (p> 0.001)
Implantation loss and offspring survival
Females with live offspring
Pre-implantation loss (%)
Post-implantation loss (%)
Live birth index (%)
Viability index (%)
Number live day 1
Number live day 4
Body weight (g) day 1 - males
Body weight (g) day 1 - females
Body weight (g) day 4 - males
Body weight (g) day 4 - females
was administered by gavage to 3 groups each of 10 male and 10 female
WistarHan:HsdRccHan:WIST rats, for up to 54 consecutive days, (including
a two week maturation phase, pairing phase, gestation and early
lactation for females) at dose levels of 10, 50 and 250 mg/kg/day. A
control group of 10 males and 10 females was dosed with vehicle alone
(Arachis oil BP). Clinical signs, body weight, food and water
consumption were monitored during the study. Pairing of animals within
each dose group was undertaken on a 1 male: 1 female basis within each
treatment group, on Day 15 of the study. Females were allowed to litter
and rear their offspring to Day 5 post partum. During the lactation
phase, daily clinical observations were performed on all surviving
offspring, together with litter size and offspring weights and
assessment of surface righting reflex. Adult males were terminated on
Day 43, and all surviving females and offspring on Day 5 post partum.
All animals were subjected to a gross necropsy examination and
histopathological evaluation of reproductive tissues was performed on
the control and high dose group parental animals.
salivation was detected soon after dosing for animals treated with 250
mg/kg/day, from Day 3 onwards, with the effect still evident up to one
hour following dosing. Increased salivation was also detected for
animals treated with 50 or 10 mg/kg/day, albeit to a lesser extent.
Slight reductions in body weight gains were evident for females treated
with 250 or 50 mg/kg/day during the first two weeks of treatment. No
adverse effects were detected for females treated with 50 or 10
mg/kg/day during the gestation and lactation phases of the study, or for
females treated with 10 mg/kg/day throughout the treatment period.
dietary intake and food efficiency were evident for females treated with
250 mg/kg/day during the first week of treatment. Food efficiencies were
similarly reduced. No adverse effects were detected for animals treated
with 50 or 10 mg/kg/day. Slight increases in water intake were evident
for 250 mg/kg/day females when compared to controls during the
maturation phase. No overt differences in water intake were evident
during the gestation and lactation phases of the study. No adverse
effects on water intake were detected for animals treated with 50 or 10
no intergroup differences in mating performance or gestation lengths.
Pregnancy was achieved for all control, 10 and 50 mg/kg/day females.
However, only five out of ten females treated with 250 mg/kg/day
produced litters. From evaluation of the corpora lutea and implantation
data, the percentage post-implantation loss at 250 mg/kg/day was much
higher when compared to the control value. Reduced litter sizes were
evident for females treated with 250 mg/kg/day when compared to controls
and also, the number of viable litters was lower. There was no obvious
difference in the sex ratio of the offspring. No adverse effects on
litter size and viability were evident from the 50 or 10 mg/kg/day dose
groups. Mean male and female offspring body weights were lower from
females treated with 250 mg/kg/day when compared to controls. No adverse
effects on body weight were evident for litters from the 50 or 10
mg/kg/day dose groups.
for maternal and developmental toxicity was 50 mg zinc
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