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Studies on single-dose toxicity of hydrophobically modified hydroxypropyl methylcellulose in rats
1Specialty Chemicals Research Center, Shin-Etsu Chemical Co., Ltd., Niigata, Japan.
Abstract:
Single-dose toxicological studies of hydrophobically modified hydroxypropyl methylcellulose (HM-HPMC, hydroxypropyl methylcellulose modified with stearylglycidylether) were conducted. A dispersion of HM-HPMC was administered to rats orally or by dermal application at doses up to 900 mg/kg. After the oral administration, the mean body weight of the 900 mg/kg group on the first day after administration was slightly but significantly lower (P less than 0.05) than that of the control group, and one rat had loose stools at 30 min. after the administration. No other abnormalities were noted. In the case of dermal application, no abnormalities were observed. No rats died, and no abnormalities in their organs were found by either route. In conclusion, there was no observed toxicity of HM-HMPC after oral or dermal administration at single dose up to 900 mg/kg under the conditions of these studies.
Insights
Hydrophobically modified hydroxypropyl methylcellulose (HM-HPMC) showed no significant toxicity in rats. Single oral or dermal doses up to 900 mg/kg resulted in minimal effects, indicating good safety for HM-HPMC.
Area of Science:
- Toxicology
- Polymer Science
- Materials Science
Background:
- Hydroxypropyl methylcellulose (HPMC) is a widely used polymer.
- Hydrophobic modification of HPMC can alter its properties for specific applications.
- Understanding the toxicological profile of modified polymers is crucial for safety assessment.
Purpose of the Study:
- To evaluate the acute toxicity of hydrophobically modified hydroxypropyl methylcellulose (HM-HPMC).
- To assess potential adverse effects following single oral and dermal administration in rats.
Main Methods:
- Single-dose oral and dermal administration of HM-HPMC dispersion to rats.
- Doses administered up to 900 mg/kg.
- Monitoring of body weight, clinical signs, and gross necropsy findings.
Main Results:
- Oral administration at 900 mg/kg showed a slight, significant decrease in body weight on day 1 and transient loose stools in one rat.
- No other abnormalities were observed after oral administration.
- No adverse effects or abnormalities were noted following dermal application.
Conclusions:
- HM-HPMC demonstrated no observed toxicity via oral or dermal routes at single doses up to 900 mg/kg.
- The study indicates a favorable safety profile for HM-HPMC under the tested conditions.
- Further investigation into chronic toxicity may be warranted if widespread exposure is anticipated.