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Two-generation reproduction studies in Rats fed di-isodecyl phthalate.
L J Hushka1, S J Waterman, L H Keller
1ExxonMobil Biomedical Sciences, Inc., Annandale NJ, USA.
Reproductive Toxicology (Elmsford, N.Y.)
|April 12, 2001
Summary
Di-isodecyl phthalate (DIDP) did not affect rat fertility but reduced offspring survival, particularly in the second generation. No-observed-adverse-effect levels were established for survival and reproductive parameters.
Area of Science:
- Toxicology
- Reproductive Toxicology
- Environmental Health
Background:
- Di-isodecyl phthalate (DIDP) is a widely used plasticizer.
- Previous animal studies suggest low toxicity for DIDP.
Purpose of the Study:
- To assess the effects of dietary DIDP on fertility and development in Sprague-Dawley rats.
- To establish No-Observed-Adverse-Effect Levels (NOAELs) for DIDP exposure.
Main Methods:
- Two-generation reproductive toxicity studies in Sprague-Dawley rats.
- Dietary administration of DIDP at levels from 0.02% to 0.8% (15-600 mg/kg/day).
- Evaluation of fertility, adult and offspring body/organ weights, survival, and developmental landmarks.
Main Results:
- No effects on fertility or live birth index observed.
- Decreased adult body weight, increased liver/kidney weights, and signs of peroxisomal proliferation noted.
- Reduced F1 offspring survival (postnatal days 1-4) and significant F2 offspring survival reduction at 0.2% DIDP and higher.
- Transient decreases in offspring body weight prior to weaning and increased food consumption.
Conclusions:
- NOAEL for F2 offspring survival established at 0.06% (approx. 50 mg/kg/day).
- NOAEL for fertility and developmental landmarks determined as 0.8% (approx. 600 mg/kg/day).
- A theoretical NOAEL for reduced F2 offspring survival was identified at 108 mg/kg/day.