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1336376 
Journal Article 
Two-generation reproduction studies in rats fed di-isodecyl phthalate 
Hushka, LJ; Waterman, SJ; Keller, LH; Trimmer, GW; Freeman, JJ; Ambroso, JL; Nicolich, M; Mckee, RH 
2001 
1 
Reproductive Toxicology
ISSN: 0890-6238
EISSN: 1873-1708 
PERGAMON-ELSEVIER SCIENCE LTD 
OXFORD 
15 
2 
153-169 
English 
11297875 
WOS:000168219700008 
uses data from 5692535 Support: two generation reproduction toxicity study in rats with MRD-94-775, final report, with cover letter dated 8/3/2000
uses data from 11328023 [Redacted] Two generation reproduction toxicity study in rats with MRD-94-775 with amendment
Di-isodecyl phthalate (DIDP) is a commercial plasticizer with low toxicity in many animal studies. The effects of dietary DIDP administration on fertility and developmental parameters were assessed in Sprague-Dawley rats utilizing two generation reproductive toxicity studies generally consistent with current regulatory guidelines. Dietary levels ranged from 0.02 to 0.8% (or approximately 15 to 600 mg/kg/day). In the reproductive studies, there were no effects on fertility, but there were decreases in adult body weight along with corresponding increases in liver and kidney weights and histopathologic changes indicative of peroxisomal proliferation. There were no effects on live birth index, but reduced offspring survival was observed at postnatal days 1 to 4. This reduced survival was more pronounced in the F2 generation in which statistical significance was achieved at levels of 0.2% DIDP and greater. There were also transient decreases in offspring body weights prior to weaning, corresponding to rapid offspring growth, and high levels of food consumption. There were no notable alterations in developmental landmarks. Overall, these studies provided experimentally defined No-Observed-Adverse-Effect Levels (NOAELs) of 0.06% (approximately 50 mg/kg/day) for F2 offspring survival and 0.8% (approximately 600 mg/kg/day) for fertility, other measures of reproductive function, and developmental landmarks. Statistical evaluation of the data from both studies identified 108 mg/kg/day with a 95% lower bound value of 86 mg/kg/day as a theoretical NOAEL for reduced F2 offspring survival. 
di-isodecyl phthalate; DIDP; reproduction; plasticizer; multigeneration; two-generation; developmental landmarks; offspring survival 
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