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EC number: 700-990-0
CAS number: 68937-40-6
Phosflex 61B was administered in doses of 0, 50, 250 or 1000 mg/kg
bw/day to rats. Treatment was done 2 weeks prior to mating, during
mating (male/female) and for female during gestation, lactation and post
partum up to day 4. Males were treated for at least 35 consecutive days.
Mortality, clinical signs, body weights, food consumption were recorded
in the parental animals. Also gross necropsy and organ weights and
histopathology for the reproductive organs were studied. Reproductive
performance was determined as well. For the litters, viability, fetal
and litter weights and gross anomalies were recorded.
No mortality or overt signs of parental toxicity were observed in the
parental rats. No effect was seen on body weight and food consumption,
while reproductive performance was normal. Gross necropsy and organ
weight data and histopathology of the reproductive organs revealed no
Mean litter size and mean number of live pups was comparable between the
treatment groups. Additionally, no effects on litter weights were
observed. Percent post-implantation loss was higher in 250 and 1000
mg/kg groups (not statistically significant). Subsequently, a
statistically significant increase in the absolute number of stillbirths
in the 250 and 1000 mg/kg groups was noted. However, overall a similar
number of pup deaths was observed across all groups. While the incidence
was the same, the timing of the event was somewhat different. In the 250
and 1000 mg/kg groups, most of the deaths occurred on day 0, while this
was after day 0 in the control group. Overall, pup survival from day 0
to 4 was lower in the 250 mg/kg group (due to 10 deaths in one litter),
higher in the 50 mg/kg group and approximately the same as control in
the 1000 mg/kg group.
Under the conditions of this study, oral (gavage) administration of
Phosflex 61B to rats did not result in overt signs of parental toxicity.
This also accounts for the offspring. Therefore, the NOAEL for parental
and developmental toxicity was established to be 1000 mg/kg bw/day.
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