A REPEATED-DOSE DERMAL TOXICITY STUDY OF HYDROPHOBICALLY MODIFIED HYDROXYPROPYL METHYLCELLULOSE IN RATS

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 sk...

Full description

Saved in:
Bibliographic Details
Published in:Journal of toxicological sciences 1997/08/10, Vol.22(3), pp.255-280
Main Authors: OBARA, Sakae, MUTO, Hiroaki, ICHIKAWA, Naoto, TANAKA, Osamu, OTSUKA, Michio, KAWANABE, Mikiko, ISHII, Hiroyuki, NIIKURA, Yoshiyuki, KOMATSU, Masahiko
Format: Article
Language:English
Subjects:
Administration, Cutaneous
Alanine Transaminase - blood
Animals
Aspartate Aminotransferases - blood
Biological and medical sciences
Blood Cell Count - drug effects
Body Weight - drug effects
Drug toxicity and drugs side effects treatment
Eating - drug effects
Female
Hypromellose Derivatives
Male
Medical sciences
Methylcellulose - administration & dosage
Methylcellulose - analogs & derivatives
Methylcellulose - toxicity
Pharmacology. Drug treatments
Rat
Rats
Rats, Sprague-Dawley
Time Factors
Toxicity: skin, dermoskeleton
Urinalysis
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0388-1350
1880-3989
DOI:10.2131/jts.22.3_255