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Safety of Hibitane. I. Laboratory experiments
Journal of Clinical Periodontology
|December 1, 1977
Summary
Extensive animal safety studies show chlorhexidine (Hibitane) is well-tolerated and not carcinogenic. These findings support its widespread use in human applications.
Area of Science:
- Toxicology
- Pharmacology
- Animal Safety Studies
Background:
- Chlorhexidine (Hibitane) has been evaluated for safety in animals for over 20 years.
- Its safety profile is continually reviewed due to expanding human applications.
Purpose of the Study:
- To review animal safety data for chlorhexidine.
- To discuss the relevance of animal studies to human use.
- To compare species responses where applicable.
Main Methods:
- Review of toxicological studies in various animal species.
- Detailed outline of a 2-year long-term study in rats.
- Assessment of absorption via oral, parenteral, and percutaneous routes.
Main Results:
- Chlorhexidine demonstrates poor oral absorption, minimal percutaneous absorption, and good parenteral tolerance.
- No clinical or histological effects in animal studies suggest contraindications for human use.
- Long-term studies, including a 2-year rat study, showed no evidence of tumor formation or other toxic signs.
Conclusions:
- Animal safety data provide a strong basis for the safe use of chlorhexidine in humans.
- The extensive toxicological profile indicates chlorhexidine is not associated with carcinogenic or significant toxic effects.