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Toxicological Sciences 55, 195-205 (2000)
Copyright © 2000 by the Society of Toxicology

Safety Evaluation

Effects of Glutaraldehyde in a 2-Year Inhalation Study in Rats and Mice

Angélique P. J. M. van Birgelen*,1, Billy J. Chou{dagger}, Roger A. Renne{dagger}, Sondra L. Grumbein{dagger}, Joe H. Roycroft*, James R. Hailey* and John R. Bucher*

* National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina; and {dagger} Battelle Pacific Northwest, Richland, Washington

Whole-body inhalation toxicology and carcinogenicity studies were performed with the widely used fixative and cold-sterilant glutaraldehyde. Groups of 50 male and female F344/N rats and B6C3F1 mice were exposed to glutaraldehyde (rats: 0, 250, 500, or 750 ppb; mice: 0, 62.5, 125, or 250 ppb) 6 h/day, 5 days/week, for 104 weeks. Survival of 500- and 750-ppb female rats was less than that of controls. Mean body weights of all exposed groups of male rats, 500- and 750-ppb female rats, and 250-ppb female mice were generally less than those of controls. No exposure-related neoplastic lesions were observed in either rats or mice. Non-neoplastic lesions were limited primarily to the most anterior region of the nasal cavity. In rats, hyperplasia and inflammation of the squamous epithelium; hyperplasia, goblet cell hyperplasia, inflammation, and squamous metaplasia of the respiratory epithelium; and hyaline degeneration of the olfactory epithelium were observed. In mice, the nasal lesions were qualitatively similar to those in rats. Squamous metaplasia of the respiratory epithelium was observed in both sexes of mice while female mice also had inflammation and hyaline degeneration of the respiratory epithelium. In contrast to the nasal carcinogen formaldehyde, no neoplastic lesions were observed after inhalation exposure to glutaraldehyde. However, exposure to glutaraldehyde resulted in considerable non-neoplastic lesions in the noses of rats and mice.

Key Words: glutaraldehyde; toxicity; carcinogenicity; nose.


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