Assessment of the Systemic Effects, Primary Dermal Irritation, and Ocular Irritation of Chlorhexidine Acetate Solutions

Abstract

The biologic effects of various chlorhexidine acetate (ClAc) solutions containing isopropyl alcohol, Synperonic NP8, and carmoisin were evaluated (1) following intraperitoneal (IP) administration in rats for 5 consecutive days followed by a 5-day recovery period, (2) by measuring the primary irritation of the skin by a patch-test technique on intact and abraded skin of rabbits, and (3) following instillation into the eyes or rabbits followed by washing 50% of the treated eyes with lukewarm water in order to evaluate ocular irritation. Physiologic saline solution served as the control article throughout the studies. There was a high incidence of deaths (i.e., 28/32 and 11/16 for ClAc solutions with and without Synperonic NP8, respectively) among rats receiving IP treatment at a dosage of 40 ml/kg per day for 5 consecutive days. No toxicologically significant treatment-related changes were observed in rats treated IP with either surfactant or isopropyl alcohol with Synperonic NP8. Toxicity of ClAc solution appears to be due to a chemically induced peritonitis with no evidence of systemic toxicity. ClAc solution or the respective surfactants elicited either no reaction or a mild dermal irritation in the rabbit. Likewise, ClAc solution with or without Synperonic NP8 and the three respective surfactants did not cause any significant ocular irritation changes that are considered of toxicologic significance. It is concluded that (1) the multiple IP administration of ClAc solution elicited a toxic response in rats, and thus, caution must be exercised when the solution is used for the purposes of peritoneal lavage, and (2) ClAc solution is a mild dermal and ocular irritant in the rabbit.