A repeated-dose dermal toxicity study of hydrophobically modified hydroxypropyl methylcellulose in rats

J Toxicol Sci. 1997 Aug;22(3):255-80. doi: 10.2131/jts.22.3_255.

Abstract

A six-month repeated-dose dermal toxicity study followed by a 30-day recovery test of hydrophobically modified hydroxypropyl methylcellulose (HM-HPMC), a new cellulose derivative used as a thickener for topical pharmaceuticals, was conducted using rats. Aqueous paste of HM-HPMC was applied to the skin of rats once daily at dose levels up to 60 mg/kg/day, which was the highest dose that could be administered. Items checked included general signs, urinalysis, hematology, ophthalmology, and histopathology. One rat died during the administration period owing to a malignant tumor in the hemopoietic system, which was not attributed to the test substance. Statistically significant differences were found in some test results, but those were not dose-dependent and were considered to be incidental or spontaneous. It was concluded that the test substance was not toxic upon chronic dermal administration at dose levels up to 60 mg/kg/day.

MeSH terms

  • Administration, Cutaneous
  • Alanine Transaminase / blood
  • Animals
  • Aspartate Aminotransferases / blood
  • Blood Cell Count / drug effects
  • Body Weight / drug effects
  • Eating / drug effects
  • Female
  • Hypromellose Derivatives
  • Male
  • Methylcellulose / administration & dosage
  • Methylcellulose / analogs & derivatives*
  • Methylcellulose / toxicity
  • Rats
  • Rats, Sprague-Dawley
  • Time Factors
  • Urinalysis

Substances

  • Hypromellose Derivatives
  • Methylcellulose
  • Aspartate Aminotransferases
  • Alanine Transaminase