Phthalates study


TITLE:

Chronic toxicity and carcinogenic evaluation of diisononyl phthalate in rats.

AUTHORS:

Lington AW; Bird MG; Plutnick RT; Stubblefield WA; Scala RA

AUTHOR AFFILIATION:

Exxon Biomedical Sciences, Inc., East Millstone, New Jersey, 08875- 2350, USA.

SOURCE:

Fundam Appl Toxicol 1997 Mar;36(1):79-89

CITATION IDS:

PMID: 9073470 UI: 97230449

ABSTRACT:

Groups of 110 Fischer 344 rats/sex were fed diisononyl phthalate (DINP) at dietary levels of 0, 0.03, 0.3, and 0.6 wt% for periods up to 2 years. Interim sacrifices of 10 predesignated rats/sex/dose were at 6, 12, and 18 months with surviving animals sacrificed at 24 months. At study termination, survival was in excess of 60% for every group. At the mid or high dose, the following biological effects were noted: slight decreases in food consumption and body weight; slight increase in mortality; a dose-related increase in relative organ weights of liver and kidney; and some slight effects on urinalysis, hematologic, and clinical chemistry parameters. No peroxisome induction was observed in livers of treated rats compared with controls. No clear treatment- related nonneoplastic or neoplastic lesions were found. However, mononuclear cell leukemia (MNCL) and changes known to be associated with an increased incidence of MNCL were seen in the mid-dose and high- dose groups. A literature review suggests that MNCL is a common finding in aging F344 rats and that this increased incidence in rats treated with DINP is not relevant to man. A clear no-observed-effect level was demonstrated for all biological end points at a dietary level of 0. 03 wt% or approximately 17 mg/kg/day of DINP. [Emphasis added]

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