Two-year evaluation of misoprostol for carcinogenicity in CD Sprague-Dawley rats.

Abstract:

:The carcinogenic potential of misoprostol, a synthetic prostaglandin E1 analogue with anti-ulcer potential, was evaluated in CD Sprague-Dawley rats. The compound was given daily by gavage at 24, 240, and 2,400 micrograms/kg, up to 150 times the daily human dose for 2 years. Necropsies were done on all animals and the incidences of non-neoplastic and neoplastic changes analyzed for significance by life table methods. The only statistically significant non-neoplastic finding was epithelial hyperplasia and hyperkeratosis of the gastric mucosa. These changes, which are characteristic of some prostaglandins, were expected. Other non-neoplastic findings were typical of known spontaneous conditions in this strain of rats. The most frequent neoplasm was the pituitary adenoma, followed by the mammary fibroadenoma, mammary adenoma, mammary adenocarcinoma, and thyroid C-cell adenoma. A rare neoplasm, squamous cell carcinoma of the ovary was found in two rats. There was no evidence that misoprostol is carcinogenic for CD Sprague-Dawley rats.

journal_name

Toxicol Pathol

journal_title

Toxicologic pathology

authors

Dodd DC,Port CD,Deslex P,Regnier B,Sanders P,Indacochea-Redmond N

doi

10.1177/019262338701500201

subject

Has Abstract

pub_date

1987-01-01 00:00:00

pages

125-33

issue

2

eissn

0192-6233

issn

1533-1601

journal_volume

15

pub_type

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