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EC number: 946-382-0
CAS number: -
No toxicologically relevant effects on reproductive parameters were
noted. Mating, fertility and conception indices, precoital time, and
number of corpora lutea and implantation sites were unaffected by
treatment. There were 1/10 couples of the control group, 3/10 couples of
the 50 mg/kg bw/ day group, 1/10 couples of the 150 mg/kg bw/ day group
and 1/10 of the 500 mg/kg bw/ day group which failed to deliver health
pups. One female treated with 50 mg/ kg bw/ day had implantation sites
only, one female in the highest dose group did not mate; all others were
No toxicologically relevant effects on gestation index and duration were
No signs of difficult or prolonged parturition were noted among the
pregnant females. Examination of cage debris of pregnant females
revealed no signs of abortion or premature birth. No deficiencies in
maternal care were observed.
EARLY POSTNATAL PUP DEVELOPMENT
Number of dead and living pups at first litter check, postnatal loss,
viability index and sex ratio were unaffected by treatment, and clinical
signs, body weight and external macroscopy did not reveal
Five pups of the control group, 2 pups at 50 mg/kg, 9 pups at 150 mg/kg
and 6 pups at 500 mg/kg were found dead or missing during the first days
of lactation. Pups missing were most likely cannibalised. No
toxicological relevance was attributed to these dead/missing pups since
the mortality incidence did not show a dose-related trend and remained
within the range considered normal for pups of this age.
CLINICAL SIGNS PUPS
Incidental clinical symptoms of pups consisted of swelling of the flank,
pale appearance, blue spots, absence of milk in the stomach, wound, and
small size. The nature and incidence of these clinical signs remained
within the range considered normal for pups of this age, and were
therefore considered to be of no toxicological relevance.
BODY WEIGHT PUPS
Body weights of pups were considered to have been unaffected by
treatment up to 500 mg/kg. The slightly lower body weights at 150 mg/kg
were not statistically significant different from control values, and
did not show a dose-response.
Incidental macroscopic findings of pups included scabbing, beginning
autolysis, cannibalism, and bent tail. The nature and incidence of these
findings remained within the range considered normal for pups of this
age, and were therefore considered to be of no toxicological relevance.
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). Pups were not dosed directly
but could have potentially be exposed to the test substance in utero,
via maternal milk or from exposure to maternal urine/faeces. At the
highest dose, adverse effects were seen in males and females on kidney,
liver and thyroid glands (females only) at 1000 mg/ kg bw/ day, which
was seen in females as minimal hypertrophy of follicular cells of the
thyroid glands and hypertrophy of the urothelium, increased absolute and
relative kidney weights, increase bilirubin levels. In males increased
(relative) liver and kidney weights were measured, furthermore changes
in blood parameters were found (increase prothrombin time, bilirubin
levels, inorganic phosphate levels and aspartate aminotransferase). No
toxicologically relevant effects on gestation index and duration,
parturition, maternal care and early postnatal pup development
(mortality, clinical signs, body weight and macroscopy) were observed at
any dose level.
Based on these data, the parental NOAEL for PEMP product was set
at 150 mg/kg bw/day, whereas the NOAEL for development was set at ≥5 00
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