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EC number: 946-382-0
CAS number: -
Analysis of dose preparations: In the control group formulation,
no test substance was detected. The concentrations analysed in the
formulations of groups exposed to 150 and 500 mg/kg bw/day were in
agreement with target concentrations (i.e. mean accuracies 98% and 100%
respectively). For the formulation of the group exposed to 50 mg/ kg bw/
day, the mean accuracy was negligibly below the target concentration
(i.e. 88% of target) and therefore the results were accepted. The
formulations of the low and high dose group were homogeneous (i.e.
coefficient of variation ≤ 7.1%). Recovery after 6 hours was found to be
78.7% and 92.9% for the low and mid dose respectively. Based on this,
the formulations of the high dose group were found to be stable when
stored at room temperature under normal laboratory light conditions for
at least 6 hours whereas the formulations of the low dose group were
found not to be stable when stored at room temperature under normal
laboratory light conditions for 6 hours. Formulations of the low dose
group were found to be stable when stored at room temperature under
normal laboratory light conditions for at least one hour (relative
difference of 4.2%).
A combined 28d repeated dose study with screening for reproductive and/
or developmental effects was performed according to OECD/EC guidelines
and GLP principles. PEMP product was administered by daily oral gavage
to male and female rats at dose levels of 50, 150 and 500 mg/kg bw/ day.
Males were exposed for 2 weeks prior to mating, during mating, and up to
termination (for 29 days). The females were exposed for 2 weeks prior to
mating, during mating, during post-coitum, and at least 4 days of
lactation (for 40-46 days). No mortality occurred. No clinical signs
were noted apart from salivation related to substance administration.
Neurobehavioural examination did not show effects of PEMP product
exposure. Furthermore, no effects were seen on body weight gain and food
consumption. Several blood parameters were affected by the treatment in
the highest dose group: males had a dose-related, statistically
significant increase in inorganic phosphate levels (+27%); total
bilirubin was increased for males and females (+32% and 48%,
respectively). In males, relative liver and kidney weights were
increased (both at +13%). In females, absolute and relative kidney
weights were statistically significantly increased (+16% and +13%
resp.). Follicular cell hypertrophy of the thyroid gland was observed
with a slightly higher incidence in 3 high dose females. Furthermore, in
females dosed at 500 mg/ kg bw/ day hypertrophy of the urothelium was
seen (minimal for two rats and slight for 2 rats). No test item-related
morphologic alterations in males were noted. Based on the adverse
effects on thyroid glands (females only), liver and kidney (both sexes)
at 500 mg/ kg bw/ day, a No Observed Adverse Effect Level (NOAEL) for
PEMP product of 150 mg/kg bw/day was established.
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