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EC number: 225-642-0
CAS number: 4985-85-7
Gestation index and duration of gestation were unaffected by treatment
up to 1000 mg/kg.
The statistical significant increase noted for duration of gestation at
1000 mg/kg was not considered toxicologically relevant as all values
were within normal limits (all individual values were either 21 or 22 days).
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 treatment-related
In a study
performed according to the OECD 422, N-(3-aminopropyl)diethanolamine
was administered by daily oral gavage followed by a 14-day recovery
period to male and female Wistar Han rats at dose levels of 100, 300 and
1000 mg/kg/day (de Raaf-Beekhuijzen, 2011). Main and Recovery animals
were exposed for 29-32 days, i.e. 2 weeks prior to mating, and during
the mating period for Main males. The Repro females were exposed for
43-57 days, i.e. during 2 weeks prior to mating, during mating, during
post-coitum, and during at least 4 days of lactation.
analysis showed that the formulations were prepared accurately and
mg/kg, parental toxicity consisted of reduced locomotor activity (total
movements) with a normal habituation pattern, reduced body weight gain
for male animals, affected haematological parameters (decreased values
for monocytes, neutrophils, red blood cells, haemoglobin, haematocrit,
and mean corpuscular volume, and increased prothrombin time, white blood
cells and lymphocytes), changes in clinical biochemistry parameters
(increased values for aspartate aminotransferase, alanine
aminotransferase, urea, calcium, potassium, total bilirubin and bile
acids, and decreased concentration of total protein and albumin), and
organ weight changes (increased liver, kidneys and adrenals weights and
decreased thymus weights). No other toxicologically relevant findings
that indicated a sign of systemic toxicity was noted. No macroscopic and
microscopic lesions were noted for systemic toxicity. The toxicological
relevance of organ weight changes is uncertain without accompanying
microscopic findings. The only apparent treatment related macroscopic
and microscopic changes was in the stomach that is probably related to
irritancy of the test substance.
several dark red or reddish foci at the glandular mucosa of the stomach
at macroscopic examination, and microscopic stomach abnormalities
consisting of acute inflammation, hyperplasia, vacuolative degeneration,
necrosis and haemorrhage.
findings recovered during the 14-day treatment free period. Acute
inflammation persisted in two male and one female animals. Even though
increased liver and kidneys weight were noted after the recovery period,
it was not considered to be toxicologically relevant without any
accompanying clinical chemistry parameters and microscopic findings.
increased absolute and/or relative kidneys weights were noted for males
and females at 300 mg/kg and for Repro females at 100 mg/kg. Only for
the Repro females at 300 mg/kg, these values were just outside the
historical control data. In the absence of corroborative changes in
clinical biochemistry parameters and histopathology, and lack of any
toxicity at these doses, the kidneys weight changes were not considered
hyperplasia of non-glandular epithelium at the stomach were noted for a
few animals treated at 300 mg/kg and one male animal each in the control
and 100 mg/kg group. However, it should be noted that thickening
(hyperplasia) of the non-glandular epithelium in the region of the
limiting ridge is a subjective opinion and is often
confounded/obfuscated by tangential sectioning. Both hyperplasia and
vacuolative degeneration of the non-glandular epithelium in the area of
the limiting ridge can be observed in normal control animals (common
findings) and are likely to be less toxicologically relevant at lower
dose levels where concomitant inflammation was not present.
mg/kg, slightly increased calcium levels were noted. In the absence of
any corroborative findings and as the change was very slight, this
finding was not considered toxicologically relevant. No toxicologically
significant changes were noted in any of the remaining parental
parameters investigated in this study (i.e. clinical appearance,
functional observations and food consumption).
reproduction toxicity was observed up to the highest dose level tested
toxicologically significant changes were noted in any of the
reproductive parameters investigated in this study (i.e. mating,
fertility and conception indices, precoital time, and numbers of corpora
lutea and implantation sites).
developmental toxicity was observed up to the highest dose level tested
toxicologically significant changes were noted in any of the
developmental parameters investigated in this study (i.e. gestation
index and duration, parturition, maternal care and early postnatal pup
development consisting of mortality, clinical signs, body weight and
conclusion, treatment with APDEA by oral gavage followed by a 14-day
recovery period in male and female Wistar Han rats at dose levels of
100, 300 and 1000 mg/kg body weight/day revealed parental toxicity at
1000 mg/kg body weight/day. No reproduction and developmental toxicity
was observed for treatment up to 1000 mg/kg body weight/day.
these results, a parental No Observed Adverse Effect Level (NOAEL) of
300 mg/kg was established. A reproduction and developmental NOAEL of at
least 1000 mg/kg/day was derived.
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