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EC number: 221-975-0
CAS number: 3302-10-1
i-Nonanoic acid was tested for its prenatal developmental toxicity in
Wistar rats. The test substance was administered as an emulsion in corn
oil to groups of 25 time-mated female Wistar rats by gavage at doses of
20, 60, and 200 mg/kg body weight/day (mg/kg bw/day) on gestation days
(GD) 6 through 19. The control group, consisting of 25 females, was
dosed with the vehicle (corn oil) in parallel. A standard dose volume of
4 mL/kg body weight was used for each test group.
The following test substance-related adverse effects/findings were noted:
Test group 3 (200 mg/kg bw/day):
Mortality in 2 dams shortly before term
Decreased food consumption towards the end of gestation (13-23% below
Decreased net body weights (8% below control) at the end of
gestation, distinctly reduced net body weight gain during treatment (47%
Increased red blood cell (RBC) counts, hemoglobin and hematocrit
Decreased relative reticulocyte counts
Increased absolute and relative monocyte and large unstained cell
Increased urea levels
Decreased total protein, albumin, globulin, cholesterol, triglyceride
and calcium levels
Increase in liver weight of absolute +13% and relative +23%
Reduced fetal weights (14% below control)
Morphological changes indicating a delay or disturbance of
development, such as increased incidences of supernumerary ribs (73.9 %
affected fetuses per litter) and wavy ribs (14.4%), incompletely
ossified Skulls 43.7%, unossified sternebra (31.5%), incomplete
ossification of metacarpal (7.3%), incomplete ossification of pubis
(4.7%), incomplete ossification of ischium (3.3%)
Increased incidence of severely altered rib cages (multiple rib
findings like wavy, bent or knobby) in 9.4% fetuses per litter,
resulting in a skeletal malformation rate of 11.1% affected fetuses per
Test group 2 (60 mg/kg bw/day):
No test substance-related adverse effects on dams, gestational
parameters or fetuses
Test group 1 (20 mg/kg bw/day):
In conclusion, the no observed adverse effect level (NOAEL) for maternal
toxicity is 60 mg/kg bw/day.
The no observed adverse effect level (NOAEL) for prenatal developmental
toxicity is 60 mg/kg bw/day, based on reduced fetal weights, as well as
a delay of development and a slightly increased malformation rate at 200
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