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A three-month repeated oral administration study of a low viscosity grade of hydroxypropyl methylcellulose in rats
Abstract:
The toxicity of the lowest viscosity grade of hydroxypropyl methylcellulose (HPMC) that is currently commercially available was investigated by means of a three-month repeated oral administration study in male and female Crj:CD (SD) IGS rats at doses of 505, 1,020 and 2,100 mg/kg/day. Body weights of males and females in the 2,100 mg/kg group were lower than those of the control group on and after day 28 of administration, but the differences were not statistically significant. The degree of suppression of body weight gain in males was higher than that in females. This tendency was similar to the results in other toxicity studies of HPMC that have been reported. Males in the 2,100 mg/kg group showed a tendency (not significant) for decreased food consumption and urine volume. Examinations of general signs, hematology, blood chemistry, ophthalmology, absolute and relative organ weights, autopsy and histopathology revealed only a few, apparently coincidental, statistically significant differences from the control, and no evidence of any dose-dependent changes was found. It was concluded that the lowest viscosity grade of HPMC showed extremely low toxicity under the conditions of this study, as has been found for higher viscosity grades.
Insights
The lowest viscosity hydroxypropyl methylcellulose (HPMC) demonstrated extremely low toxicity in a three-month rat study. No significant adverse effects or dose-dependent changes were observed, confirming its safety profile.
Area of Science:
- Toxicology
- Pharmacology
- Food Science
Background:
- Hydroxypropyl methylcellulose (HPMC) is a widely used excipient.
- Previous studies indicate low toxicity for higher viscosity HPMC grades.
Purpose of the Study:
- To evaluate the toxicity of the lowest commercially available viscosity grade of HPMC.
- To determine potential adverse effects following repeated oral administration in rats.
Main Methods:
- A three-month repeated oral administration study was conducted in male and female rats.
- Doses administered were 505, 1,020, and 2,100 mg/kg/day.
- Comprehensive toxicological assessments including hematology, blood chemistry, and histopathology were performed.
Main Results:
- Slight, non-statistically significant decreases in body weight were observed in the highest dose group (2,100 mg/kg/day).
- Males exhibited a greater tendency for reduced body weight gain, food consumption, and urine volume compared to females.
- No dose-dependent changes or significant adverse effects were identified across all toxicological parameters.
Conclusions:
- The lowest viscosity grade of HPMC exhibits extremely low toxicity.
- The safety profile is consistent with that of higher viscosity HPMC grades.
- HPMC is considered safe for oral administration under the study conditions.