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EC number: 292-562-0
CAS number: 90640-43-0
Summary of clinical observations
C (0 mg/kg)
LD (1.25 mg/kg)
MD (5 mg/kg)
HD (20 mg/kg)
Total number of animals examined
Moving the bedding
Bloody nasal discharge
Half eye lid closure
Summary of prenatal data
Terminal Body weight (g)
Uterus weight (g)
Adjusted maternal weight (g)
Sex Ratio (M/F)
Summary of Fetal Visceral Examination
0 mg/kg bw
1.25 mg/kg bw
5 mg/kg bw
20 mg/kg bw
No. Of litters evaluated
No. Of pups evaluated
Hemorrhagic Kidney (B)
Convoluted Ureter (B)
Dilated Renal Pelvis (L)
Summary of Fetal Skeletal Examination
Supernumerary rib-14th T (B)
Supernumerary rib-14th T (R)
This Prenatal developmental toxicity
study of N-Oleyl-1,3-diaminopropane was conducted in pregnant female
Wistar rats to detect the possible adverse effect on pregnant females
and embryofetal development when administered by oral gavage from
respective gestation day 0 to 19.
Nulliparous and non pregnant females
were mated with males (2:1 ratio) and divided into four groups based on
their body weights on day of positive vaginal smears (GD 0). Four groups
of presumed pregnant females were dosed daily by oral gavage with 1.25,
5 and 20 mg/kg body weight per day of N-Oleyl-1,3-diaminopropane at dose
volume of 4 mL/kg body weight. Control animals were handled identically
as treated groups and received vehicle in similar volume as treated
groups. The test item formulation was prepared freshly and dose volumes
were adjusted based on the most recent body weight measurement. Animals
were examined daily for the clinical signs and mortality. Body weight
and food consumption was measured on various gestation days. The treated
and control females were sacrificed on respective gestation day 20.
Followed by the gross necropsy
evaluation of the females, the uteri and ovaries were removed, weighed
and examined for number of implantations, resorptions (early and late)
live and dead fetuses. Fetuses were identified by colour strings, sexed
and weighed. All fetuses were observed for the external abnormalities,
half of the fetuses for the visceral abnormalities, craniofacial
examination and remain half of the litter for skeletal abnormalities.
Uteri of the non pregnant females were processed with 0.5 % ammonium
sulphide solution and checked for the early embryonic deaths if any.
Test item related clinical signs were
observed in high dose females during the entire treatment period. Also
effects on clinical observations were observed in animals of the MD
However, there were four decedents in
this study [1 in MD group (Animal 62) and 3 in HD group (Animals 80, 82
and 98)]. Animal no. 82 was euthanised for humane reason. The death of
two animals (Animals 62 and 98) were considered due to gavaging error
and other two (Animals 80 and 82) might be considered due to toxicity.
Statistically significant decrease was
observed for body weight and body weight change throughout the gestation
period in HD group. Statistically significant decrease in overall food
consumption was observed in HD group compared to corresponding control.
Statistical analysis of prenatal data revealed significance in prenatal
parameters like gravid uterus weight and adjusted maternal weight in HD
group compared to corresponding controls. No other prenatal parameters
like No. of corpora lutea, implantations percent preimplantation loss,
group mean number of live fetuses, early resorptions, late resorptions,
total resorptions, group mean number of female fetuses, sex ratio
(M/F) and percent post implantation loss showed statistical deviation
compared to corresponding controls.
Statistically significant difference
was observed for group male litter weight (LD group), sex ratio (LD and
MD groups) and total number of male fetuses (LD group) compared with
controls. These findings were not attributed to toxicity as no dose
related pattern was observed. Decrease in pregnancy rate was observed in
HD group (69.56%) as compared to LD (96%), MD (95.8%), and control
Few gross external abnormalities were
seen in fetuses among the control and treatment groups. Typical external
findings noted were protruding tongue, malrotated limbs, micrognathia,
edematous neck, small neck and hematoma (localised).But no statistical
deviation was observed for these above findings except for hematoma
which were localised and did not show dose related pattern.
Internal observation of the viscera by
free hand micro discussion technique revealed range of visceral
abnormalities in all groups including control. However, the statistical
analysis revealed differences for findings viz., hemorrhagic
kidney-bilateral (HD group), convoluted ureter-bilateral (HD group),
dilated renal pelvis-left side (MD group), split thymus (MD), small
spleen (MD group). Most of the above findings (except for hemorrhagic
kidney and convoluted ureter in HD group) were not attributed to
toxicity due to lack of dose dependent effect.
Craniofacial examination by razor
blade serial sectioning technique revealed no statistical significant
difference for any of the findings observed in treatment and control
Skeletal examination of the Alizarin
red stained fetuses revealed a range of abnormalities which were of a
type or which occurred at an incidence in both treatment and control
groups. The statistical difference observed for supernumerary 14th
rib-right side-bilaterally (MD group) and right (HD group), large
naso-frontal suture (MD group), incomplete ossification of 4th
sternebrum (LD group), split interparietal (HD group) and small hyoid
(HD group) were attributed to toxicity, but the statistical difference
observed for other anomalies were not considered of toxicological
relevance due to lack of dose related pattern.
The terminally sacrificed animals
belonging to the HD group revealed incidences of few lesions at
necropsy, which were as gas filled stomach and intestine, whitish spots
on adrenals, discoloured liver, small spleen and thymus, enlarged
adrenals, bloody lung, discoloured heart, bloody lung. The finding like
dark coloured food rest in caecum observed in most of the animals of
control and treatment groups cannot be considered as toxicity related
and in most of the animals this finding observed was not reported.
Based on the findings, the NOAEL (No
observed adverse effect level) for maternal toxicity is believed to be
1.25 mg/ kg body weight based on clinical observations seen in some
animals at 5 mg/kg, whereas the NOAEL for embryo-fetal toxicity is
believed to be 20 mg/ kg body weight.
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