Subchronic and developmental toxicity studies in rats with Ac-Di-Sol croscarmellose sodium.

Studies were conducted to evaluate the subchronic and developmental toxicity of Ac-Di-Sol (croscarmellose sodium). In the subchronic study, groups of Sprague-Dawley rats (20/sex/group) received 0 (control), 10000, or 50000 ppm Ac-Di-Sol in the diet for 90 consecutive days (equivalent to 757 and 893 mg/kg/day for males and females fed 10000 ppm, respectively, and to 3922 and 4721 mg/kg/day for males and females fed 50000 ppm, respectively). No mortality, clinical signs of toxicity, or adverse toxicological effects on hematology or serum chemistry parameters, feed consumption, or ophthalmologic examinations were noted in any treatment group.

Developmental toxicity study of Aquacoat ECD ethylcellulose aqueous dispersion administered orally to rats.

A developmental rat toxicity study of Aquacoat((R)) ECD was performed as part of a program to evaluate the safety of the product. Groups of 25 presumed-pregnant Charles River Sprague-Dawley CD rats received doses of 0, 903, 2709 and 4515mg/kg/day (dry weight basis) of Aquacoat ECD administered undiluted once daily via oral gavage on days 6-15 of gestation. All surviving dams underwent caesarean sectioning on day 20 of gestation.

Subchronic oral toxicity study of Aquacoat ECD ethylcellulose aqueous dispersion in the rat.

Groups of 20 male and 20 female Sprague-Dawley rats were administered undiluted Aquacoat ECD ethylcellulose aqueous dispersion by oral gavage at doses of 903, 2709 or 4515 mg/kg body weight/day (dry weight basis) for 90 days. Control animals received water at the same dosage volume as the high-dose group. Body weights and food consumption were recorded weekly.

A dietary oncogenicity study of tributyl phosphate in the CD-1 mouse.

Tri-n-butyl phosphate (TBP), an industrial chemical, was administered in the diet at concentrations of 0, 150, 1000 or 3500 ppm to groups of 50 male and 50 female CD-1 mice for 18 months. Survival, clinical signs and hematology parameters were unaffected by treatment at any concentration. Initial weight losses and significant decreases in body weight gain occurred in males and females receiving the high dose (3500 ppm) of TBP in diet.

Respiratory sensitization to konjac flour in guinea pigs.

Medical reports linking asthma and occupational exposure to airborne powder produced during the manufacture of konjac flour have been reported in the literature. This study was conducted to investigate whether exposure to food grade konjac flour, which is the end product of the manufacturing process, could produce respiratory hypersensitivity using an animal bioassay developed by Karol et al. (Karol, Y.