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EC number: 939-485-7
CAS number: 218141-16-3
The concentrations analysed in the formulations of the low dose group
used for dosing in week 1 and week 13 were in agreement with target
concentrations (i.e. mean accuracies between 95% and 112%). For the low
dose group formulation of week 6, a mean accuracy of 34% was obtained,
which falls outside the 85-115% criterion range. No irregularities were
noted in dose preparations in this period, however a possible cause
could be at the point of drawing the sample for analytical control.
Additional analysis on the low dose group formulation was performed in
week 7. The mean accuracy of these formulations were 85% and fell within
the criterion range. Since the single discrepancy was only noted in the
low dose formulation, this does not affect the study validity and
The mean accuracies of mid and high dose formulations were 96-108%. No
test item was detected in the control group formulations.
The formulations of low and high dose groups were homogeneous (i.e.
coefficient of variation ≤ 5.5%).
The 90 day study (OECD 408) was
performed using dose-groups of 0, 5, 15 and 50 mg/kg, based on results
from earlier 14-day RF and OECD 422 repeated dose and reproduction
screening studies. The test substance was administered dissolved in
water by gavage daily for 90 days.
The following parameters were
evaluated: clinical signs daily; functional observation tests in week
12, body weight and food consumption weekly; ophthalmoscopy at pretest
and in week 13; clinical pathology and macroscopy at termination; organ
weights and histopathology on a selection of tissues.
Results: One female at 50 mg/kg was
found dead prior to necropsy after blood sampling. This animal showed no
signs of imminent death and no other animals of the same group showed
any toxicologically relevant clinical signs. Therefore, this death was
not considered test item related, but to be the result of the blood
Besides a dose related increase of
incidence of salivation after dosing, no toxicologically relevant
clinical signs were noted during daily detailed clinical observations or
during weekly arena observations.
No adverse effects were observed in
any of the parameters examined in this study across all treatment
groups. Functional observation tests revealed lower forelimb grip
strength for males at 50 mg/kg. This finding was considered not to
represent an adverse effect on neurobehaviour, since this was not
supported by clinical observations or other functional observation tests
(including hindlimb grip strength), no supportive morphological
correlates in examined neuronal tissues were recorded, and since the
mean forelimb grip strength value was within the range considered normal
for rats of this age and strain.
During histopathology examination, an
increased incidence and severity of follicular cell hypertrophy was
observed in the thyroid glands of 50 mg/kg males. Given the nature and
the mild severity, this finding is considered to be non-adverse.
Slight, possibly treatment-related,
changes in haematological parameters were noted at 50 mg/kg. This
included higher relative eosinophil levels in females and lower relative
reticulocyte levels in males, which occurred in the absence of
concurrent treatment-related morphological changes, signs of allergic
responses or changes in related hematological parameters and were within
the normal range for animals of this strain and age. In this context,
these findings are considered non-adverse.
Conclusion: From the results presented
in this report a No Observed Adverse Effect Level (NOAEL) for
3-(Isodecyloxy)-1-Propanamine of at least 50 mg/kg was established.
doses were not tested since it was expected that a dose level higher
than 50 mg/kg was not tolerated (based on previous results).
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