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EC number: 410-800-5 | CAS number: -
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:
· Four 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.
· Another 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.
· Number 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.
· Pregnancy 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 generations.
NECROPSY / HISTOPATHOLOGY FINDINGS
· No 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 0.1% disodium.
HEDP on GD 5 - 15 had significantly more pups than controls or test animals fed the same dietary level continuously.
Mean live litter size:
· F0 for F1a:
+ Continuous feeding: 13.0/12.2/12.6
+ Fed GD 5 - 15: 13.0/12.7/9.8 (P<0.05)
· F0 for F1b:
+ 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 evaluation.
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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