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EC number: 410-800-5
CAS number: 143239-08-1
Growth, feed consumption and feed efficiency from weaning to
maturity not significantly affected by treatment (data not reported)
Effects with dose level: 0, 0.1%, 0.5%
There were a total of 5 unscheduled maternal deaths among females
given 0.5% HEDP on GD 5-15:
F0 females (2 continuous treatments, 2 treated on GD 5 - 15) died prior
to study termination (i.e. before birth of F1b). Cause: 1 case of
pneumonia, 1 thyroid tumor, 2 unspecified.
high dose female (treated on GD 5 - 15) "died on day 25 of the third
phase" (i.e. phase of study unclear), two days subsequent to delivery of
7 dead pups, with 5 pups remaining in the uterus.
of pregnancies (%): no significant effect or qualitative trend after
continuous feeding to both sexes or on GD 5 - 15 to pregnant females of
F0 or F1b generations.
rates (%): no significant effect or qualitative trend after continuous
feeding to both sexes or on GD 5 – 15 to pregnant females of F0 or F1b
NECROPSY / HISTOPATHOLOGY FINDINGS
treatment related pathology present (no further details)
Treatment during organogenesis (GD 5 - 15) resulted in a
significant reduction (P<0.05) in the number of live F1a pups born to F0
dams fed 0.05% disodium HEDP and a non-significant increase in the
number of stillborn F1b fetuses at this treatment level. F0 dams given
HEDP on GD 5 - 15 had significantly more pups than controls or
test animals fed the same dietary level continuously.
Mean live litter size:
+ Continuous feeding: 13.0/12.2/12.6
+ Fed GD 5 - 15: 13.0/12.7/9.8 (P<0.05)
+ Continuous feeding: 10.4/10.2/12.8
+ Fed GD 5 - 15: 10.4/13.5 (P<0.05)/12.7
Mean number stillborn per litter:
+ Continuous feeding: 2/4/2
+ Fed GD 5 - 15: 2/2/5
+ Continuous feeding: 6/10/9
+ Fed GD 5 - 15: 6/15/22
The number of live births for the F2a litters was
indistinguishable from control.
Preweaning mortality, mean number weaned per litter, mean weaning
weight: no significant effect or qualitative trend
In F1a, F1b and F2a litters after continuous feeding to both sexes
or on GD 5 - 15 to pregnant females.
The disodium salt of HEDP was fed in a 2-generation study via the diet
to Charles River rats at dose levels of 0, 112 or 447 mg active salt/kg
bw/d (Nolen and Buehler, 1971).
The test material was dosed continuously to both sexes, or to pregnant
females between gestation days 5-15. No treatment-related effects on
pregnancy rate were observed. The F0 females were allowed to deliver two
litters (i.e., F1a, F1b) while a third (F1c) was used for a teratology
For the mating procedure, one male and female rat was placed in a mating
cage. The start of pregnancy was determined on the basis of a positive
vaginal smear. Five weanlings of F1a were subject to necropsy and
histological examinations. The remaining pups of F1a were discarded
after weaning. Litters of F1b were used for breeding the F2 generation.
The group sizes were 22/sex/treatment for F0 and F1 and 20/sex/treatment
for F1b and F2.
In-life observations such as body weights and food intake were recorded
from 8 weeks pre-mating on. The litter observations were not described.
Generally, growth, feed consumption and feed efficiency from weaning to
maturity were not significantly affected by the treatment. There were
also no treatment-related effects on pregnancy rate, number of live
litter size and mean number of stillborn per litter.
The NOAEL for reproductive toxicity was determined to be greater than
447 mg/kg bw/d, the highest dose tested. There was only limited
information available with regard to the study design. However, a few
deviations from the OECD guideline protocol were apparent.
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