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.
Highlights
The approximate lethal dose (ALD) of CB was estimated to be greater than 250 mg/kg b.w./day in male and female rats
CB is widely used as a preservative in cosmetics, sedatives, and hypnotics, widely used asaapreservative preservative incosmetics, cosmetics, sedatives, andhypnotics, hypnotics, thereAlthough is a lack of oral toxicityused assessment data
This study aimed to investigate the potential toxicity of Several previous potential toxicity of CB.toxicity studies reported that the CB oral LD50 in rats was close to Several previous toxicitystudies studies reported that theCB
Summary
Chlorobutanol (CB; 1,1,1-trichloro-2-methyl-2-propanol), an alcohol-based preservative, has a broad spectrum of antimicrobial action in many consumer products [1,2]. Preservatives, such as CB, are included in ophthalmic solutions to maintain the shelf life of the product and to prevent contamination during the treatment period of the patient [3]. CB is known to undergo hydrolysis at elevated temperatures, forming hydrochloric acid and other acidic reaction products [9] This is likely to explain the change in pH of preparations that contain CB, which has been observed at 40 ◦ C. This effect was even more pronounced at 80 ◦ C, with both preparations showing a pH of 2.0 in 5 days [10]
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call