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Single- and repeated-dose 28-day oral toxicity study of MDM hydantoin in Sprague-Dawley rats
Hansol Won1, Jin Hee Lee1, Ji-Hyun Seok1
1Toxicological Research Division, National Institute of Food and Drug Safety Evaluation, 187, Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28159 Republic of Korea.
Abstract:
1-(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (MDM hydantoin) is a commonly used antiseptic preservative in cosmetics. However, limited toxicity information data are available for this chemical. The aim of this study was to obtain toxicity data for MDM hydantoin through single- and repeated-dose toxicity studies in Sprague-Dawley (SD) rats. In the single-dose toxicity study, MDM hydantoin was administered once orally to SD rats at four doses (5, 50, 300, and 2000 mg/kg/day). There was no significant difference in mortality, clinical signs, and body weight change for 14 days among the animals treated with the different doses in this study. Hence, the approximate lethal dose of MDM hydantoin was considered higher than 2000 mg/kg/day. Based on the results of the dose-range finding study, a 28-day repeated-dose oral toxicity study was conducted. MDM hydantoin was administered orally to SD rats at doses of 125, 250, 500, and 1000 mg/kg/day throughout an experimental period of 28 days. In the repeated-dose oral toxicity study, the adverse effects caused by MDM hydantoin were not detected in terms of body weight, clinical signs, food and water intake, hematology, organ weights, gross pathology, and histopathology. Therefore, the no-observed-adverse-effect level of MDM hydantoin was considered to be greater than 1000 mg/kg/day.
Insights
1-(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (MDM hydantoin) is a safe cosmetic preservative. Toxicity studies in rats showed no adverse effects, establishing a high no-observed-adverse-effect level for this commonly used ingredient.
Area of Science:
- Toxicology
- Cosmetic Science
Background:
- 1-(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (MDM hydantoin) is widely used as an antiseptic preservative in cosmetic products.
- Limited toxicity data currently exists for MDM hydantoin.
Purpose of the Study:
- To evaluate the toxicity of MDM hydantoin through single- and repeated-dose studies.
- To determine the safety profile of MDM hydantoin for cosmetic applications.
Main Methods:
- Single-dose oral toxicity study in Sprague-Dawley (SD) rats at doses up to 2000 mg/kg/day.
- 28-day repeated-dose oral toxicity study in SD rats at doses up to 1000 mg/kg/day.
- Comprehensive evaluation of clinical signs, body weight, hematology, organ weights, and histopathology.
Main Results:
- The approximate lethal dose of MDM hydantoin was determined to be higher than 2000 mg/kg/day.
- No significant adverse effects were observed in repeated-dose studies across all measured parameters.
- The no-observed-adverse-effect level (NOAEL) for MDM hydantoin was established as greater than 1000 mg/kg/day.
Conclusions:
- MDM hydantoin demonstrates a low toxicity profile.
- The established NOAEL supports the safe use of MDM hydantoin as a cosmetic preservative.
- Further research may explore long-term exposure effects.
