In Vivo Evaluation of the Oral Toxicity of the Chlorobutanol

Abstract

Chlorobutanol (CB) is used as a preservative in cosmetics and has antibacterial activity. This study investigated the single- and repeated-dose 28-day oral toxicity of a CB solvent in Sprague Dawley (SD) rats. For the single-dose oral toxicity study, a dose of 62.5, 125, or 250 mg per kg of body weight (mg/kg b.w.) of CB was given once orally via gavage. For the repeated-dose 28-day toxicity study, the high dose was set as 100 mg/kg b.w./day, and the middle, middle-low, and low doses were set to 50, 25, and 12.5 mg/kg b.w./day, respectively. Body weight was not significantly changed in the repeated-dose toxicity study. Relative liver and kidney weights were significantly increased in both sexes of the 100 mg/kg b.w./day treatment group. However, there were histopathological changes in liver and kidney for females and males, respectively. These data suggested that the approximate lethal dose (ALD) of CB was over 250 mg/kg b.w./day in the single-dose study, and the no adverse effect level (NOAEL) for CB was over 50 and 12.5 mg/kg b.w./day for female and male rats in the repeated-dose toxicity study.

Microbial contamination of cosmetics and the pharmaceutical products, and their preservation strategies: A comprehensive review

“…In addition, it is the active ingredient in several oral sedatives and topical anaesthetics. Furthermore, chlorobutanol was once advertised in several nations as an antiseptic mouthwash and a preservative in the topical pastes; intravenous vitamin formulations, and several other medications (Jeong et al, 2022). However, as it shows slow antibacterial activity, it is combined with other preservatives in some commercially available eye drops (Maiti et al, 2016).…”