Evaluation of the chronic toxicity and carcinogenicity of perfluorohexanoic acid (PFHxA) in Sprague-Dawley rats.

Perfluorohexanoic acid (PFHxA), a 6-carbon perfluoroalkyl (C6; CAS # 307-24-4), has been proposed as a replacement for the commonly used 8-carbon perfluoroalkyls: perfluorooctanoic acid and perfluorooctane sulfonate. PFHxA is not currently a commercial product but rather the ultimate degradation product of C6 fluorotelomer used to make C6 fluorotelomer acrylate polymers. It can be expected that, to a greater or lesser extent, the environmental loading of PFHxA will increase, as C6 fluorotelomer acrylate treatments are used and waste is generated.

Evaluation of propofol containing 2% benzyl alcohol preservative in cats.

Propofol emulsion containing benzyl alcohol preservative (BA) was evaluated in cats. Eight (PB) received 1% propofol containing 2% benzyl alcohol and eight (PC) preservative-free propofol. In phase 1, cats were anaesthetised (8 mg/kg) three times at 48 h intervals.

Comparison of the toxicokinetic behavior of perfluorohexanoic acid (PFHxA) and nonafluorobutane-1-sulfonic acid (PFBS) in cynomolgus monkeys and rats.

The toxicokinetics of perfluorohexanoic acid (PFHxA) and nonafluoro-1-butanesulfonic acid (PFBS) were evaluated in Sprague-Dawley rats and cynomolgus monkeys. Systemic exposure to PFHxA was lower than for PFBS following single equivalent intravenous or oral (rat only) doses. Serum clearance was more rapid for PFHxA than for PFBS.

A 90-day repeated dose oral (gavage) toxicity study of perfluorohexanoic acid (PFHxA) in rats (with functional observational battery and motor activity determinations).

Possible toxic effects of perfluorohexanoic acid (PFHxA) were evaluated when administered orally by gavage to rats at levels up to 200mg/kg/day for 90 days. Lower body weight gains were noted in the 10, 50 and 200mg/kg/day group males (not dose-responsive) throughout dosing. Other changes included lower red blood cell parameters, higher reticulocyte counts and lower globulin in the 200mg/kg/day group males and females, higher liver enzymes in males at 50 and 200mg/kg/day, lower total protein and higher albumin/globulin ratio, and lower cholesterol, calcium in males at 200mg/kg/day.

Safety assessment of heat-sterilized green tea catechin preparation: a 6-month repeat-dose study in rats.

Evidence suggests that the purported health benefits associated with green tea consumption are related to tea catechins. In the present study, potential adverse effects of a standardized heat-sterilized green tea catechin (GTC-H) preparation was investigated following gavage administration to rats at doses of 0, 120, 400, 1200 mg/kg/day for 6 months. A decaffeinated high-dose group (1200 mg/kg/day) (GTC-HDC), was included for comparison.

Safety assessment of heated diacylglycerol oil: subchronic toxicity study in rats.

Diacylglycerol oil is an edible oil with similar taste and usability characteristics as conventional edible oil rich in triacylglycerol oil. The objective of the present study was to evaluate potential adverse effects of heated diacylglycerol and triacylglycerol oil in rats following subchronic administration. The heated diacylglycerol and triacylglycerol oils were prepared separately following deep frying potato slices at 180 degrees C for 8h per day for three days.

28-Day oral (gavage) toxicity studies of green tea catechins prepared for beverages in rats.

The beneficial health effects associated with drinking green tea are widely considered to be due primarily to tea catechins. Heat treatment of marketed green tea beverages for sterilization causes epimerization and/or polymerization of tea catechins. Safety studies on heat-treated tea catechins are limited.

A 28-day oral (dietary) toxicity study of sucromalt in Sprague--Dawley rats.

A new sweetener, sucromalt, was produced via enzymatic conversion of sucrose and maltose to a mixture of fructose, leucrose and gluco-oligosaccharides. The present study evaluated the safety of this sweetener when administered as a dietary admix at concentrations of 50, 100 and 200 g/kg to Sprague-Dawley rats for 28 days. There were no treatment-related effects on the general condition and behavior as determined by clinical observations, functional observational battery and locomotor activity assessments.

Different species require different correction factors for the QT interval.

The ICH S7B guideline specifically requests the evaluation of the QT interval in in vivo models as an accepted risk factor for fatal tachyarrythmias. While it recommends correcting the QT interval for heart rate (HR), it also concedes that such corrections can yield misleading results. Data acquired from 40 cynomolgus monkeys (CM) and 66 Beagle dogs (BD) on 64 and 166 episodes, respectively, of 25-h ECG data collection in healthy control group animals were analyzed for this publication.

A 24-month dietary carcinogenicity study of DAG (diacylglycerol) in rats.

Toxicologic and carcinogenic effects of DAG (diacylglycerol) oil, administered in diet for 24 months to Crl:CD((R))(SD)-IGS BR rats, were evaluated using diet-restricted and ad libitum-fed groups. All dietary fat (consistently 5.5%) was provided by DAG and/or the control article, TG (triacylglycerol) oil.

A chronic dietary toxicity study of DAG (diacylglycerol) in Beagle dogs.

The potential chronic toxic effects of DAG (diacylglycerol) when administered orally for 12 months were evaluated in this dietary study in Beagle dogs. DAG is a cooking oil which contains >80% diglycerides, <20% triglycerides and 5% monoglycerides. For this study, a special diet was prepared with no dietary fat so that all of the dietary fat could be provided by DAG, at various concentrations together with a control oil.

A 24-month dietary carcinogenicity study of DAG in mice.

This study evaluated the possible carcinogenic effects of DAG (diacylglycerol) oil when given in the diet at levels up to 6.0% for 24 months to mice. Dietary fat was provided by DAG and/or the control article, TG (triacylglycerol oil).

A 24-hour continuous infusion study of bivalirudin in the rat.

The potential toxic effects of bivalirudin (an anticoagulant) were evaluated in this intravenous infusion study in Sprague-Dawley rats. Bivalirudin was administered over a 24-hour period by continuous intravenous infusion to six groups of rats. Dose levels of 100, 500, and 2000 mg/kg/24 h were selected for the low-, mid-, and high-dose groups.