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EC number: 230-528-9
CAS number: 7173-62-8
oral two-generation study was conducted to assess the reproductive
toxicity potential of N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine in
rats according to the OECD Guideline 416 and in compliance with GLP.
Dawley rats were dosed orally by gavage, once daily at dose levels, 0,
10, 30 and 90 mg/kg/day (i.e., equivalent to 0, 3, 9 and 27 mg a.i./kg
bw/day). F0 animals were randomised into the 4 treatment groups, each
containing 28 males and 28 females. From each treatment group, 24 male
and 24 female F1 weanlings were selected for rearing to maturity and
mating to produce the F2 generation. The F0 animals were dosed for 10
weeks prior to mating, and then throughout the mating, gestation and
lactation periods until sacrifice at the time of weaning of the F1
F1 animals were exposed to possible effect of the test substance from
conception through to weaning. Clinical observations were performed
daily. Body weight and food consumption were recorded at various
intervals throughout the study. Females were allowed to litter normally
and observations on the females and litters were recorded. All
F0 and F1 animals were subjected to necropsy, consisting of an external
examination, followed by macroscopic examination of the tissues and
organs of the cranial, thoracic and abdominal cavities. Gross lesions
were monitored and applicable organs were weighed. Only
2 male and 2 female pups that were weaned from each litter underwent
histopathology was performed as this was available from a 90-day repeat
oral dose study.
to parent (adult) animals at 27 mg a.i./kg
indicated in both generations by a marked reduction in body weight gain
of males, and of females during the pre-mating and gestation periods.
Food consumption at this level was slightly lower than control. Additionally
most animals in both generations receiving 27 mga.i./kg
clinical signs of reaction to treatment (principally dyspnoea,
piloerection and hunched posture, many animals also had episodes of post
dose salivation, and for occasional animals the outline of the spine was
prominent). A total of 8 animals (2 F0 males, 3 F0 females, 1 F1 male
and 2 F1 females) died or were killed after showing marked signs of
reaction, and a ninth death (of an F1 female) may also have been related
to treatment. At
the only finding that was considered to have been probably associated
with treatment was occasional animals in both generations with post
dosing salivation; this finding might not be indicative of systemic
seminal vesicle weights in both generations at 27 mga.i./kg
significantly lower than control; it was considered that this reduction
was an indirect effect of the lower body weights rather than a direct
effect on the seminal vesicles.Mating
performance, fertility, duration of gestation, litter size and pup
survival were considered to be similar in all groups of both
mean litter weight and pup weights of the F2 pups were slightly lower
than control; although these differences were probably incidental, the
possibility that they indicated a slight effect of treatment could not
be entirely discounted. The litter and pup weights of the F1 pups at 27
and of both generations at 3 and 9 mga.i./kg
were similar to control. Two
pups at 27 mga.i./kg
body tremors in late lactation; these may have been associated with
the 3 mga.i./kg
level no marked toxicity was noted.
under the conditions of the study, the NOAEL for reproductive toxicity
was established at 27 mg a.i./kg bw/day and the NOAEL for parental and
developmental toxicity was established at the next tested lower dose
level of 9 mg a.i./kg bw/day.
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