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EC number: 254-052-6
CAS number: 38640-62-9
Short description of key information:
No data have been located concerning toxicity to reproduction.
In a developmental toxicity study (LPT 1993) according to OECD TG 414, the following effect levels were determined:NOAEL maternal: 100 mg/kg bw/day NOEL embryotoxicity: 625 mg/kg bw/day (highest dose tested)NOEL fetotoxicity: 625 mg/kg bw/day (highest dose tested) NOEL teratogenicity: 625 mg/kg bw/day (highest dose tested)
Range finding study
Dose selection was based on the
range-finding study using 2 pregnant rats dosed at 100, 350, 750 and
1000 mg/(kg bw*d). 100 and 350 mg/(kg bw*d) were well tolerated, while
750 mg/(kg bw*d) was within the incipient maternal and fetotoxic range.
No developmental toxicity was observed
at the highest dose tested with incipient maternal toxicity.
Fertility rate: 95.5 % (control and
100 % (100- and
No significant differences from the
control were noted in all reproductive parameters.
Controls: 11.9 %
100-mg group: 5.8 %
250-mg group: 10.1 %
625-mg group: 9.4 %
* including one dead
No particular developmental adverse
effects on the fetuses of any treatment group were observed, comprising
physiological (body weight and body length) as well as morphological
parameters (malformations and variations).
Autopsy findings: none
There were no fetal deaths but one in
the 250-mg group.
Pregnant rats were treated by gavage
with DIPN in sesame oil at dose levels of 0, 100, 250, and 625 mg/kg
bw/day from day 6 to day 15 of gestation.
The treatment of pregnant rats
produced no pathologically relevant effects, either in the dams or in
the offspring. The authors´ conclusion of a very slight trend towards an
increased incidence of skeletal retardation at the mid and high dose
level is not evident from the results tables.
Transient significant reduction in
feed consumption and body weight gain were observed during maternal
respect to the maternal body-weight effect, the NOAEL for maternal
toxicity is assumed to be 100 mg/(kg*d). Due to the absence
of embryotoxic effects, the highest dose, 625 mg/(kg*d),
corresponds to a NOEL for developmental effects (embryo-/fetotoxicity
on results for developmental toxicity / teratogenicity, classification
is not indicated.
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