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<p>Methylene bis-benzotriazolyl tetramethylbutylphenol (MBBT) is a UV filter and UV absorber used in cosmetics. In this study, the acute toxicity, repeated dose toxicity, skin irritation, ocular irritation, skin sensitization, reproductive, and developmental toxicity, genotoxicity, carcinogenicity, toxicokinetics, and dermal absorption of MBBT were evaluated. The oral and dermal LD<sub>50</sub>s of non-nanoform MBBT in rats were 2&#xa0;g/kg. The LC<sub>50</sub> of nanoform MBBT in rats was 0.488&#xa0;mg/L. Neither 20% nanoform MBBT nor 65% non-nanoform MBBT caused skin irritation. Moreover, 50% nanoform MBBT did not cause ocular irritation and 30% non-nanoform MBBT did not induce skin sensitization. In reproductive and developmental toxicity studies in rats, neither male nor pregnant female rats nor fetuses exhibited adverse effects after receiving up to 1000&#xa0;mg/kg/day of non-nanoform MBBT. In vitro bacterial reverse mutation assays, micronucleus tests, and gene mutation assays, as well as in vivo micronucleus assays, yielded negative results. The NOAEL of MBBT was determined to be 1000&#xa0;mg/kg/day (the highest dose tested) on the basis of the results of a 90-day repeated dermal toxicity study in rats. The NOAEL was optimized to the internal dose by applying a dermal absorption rate of 5.922%, resulting in a systemic point of departure (PODsys) for MBBT of 59.22&#xa0;mg/kg/day. The systemic exposure dose was calculated to be 0.0136&#xa0;mg/kg/day. The margin of safety of MBBT was calculated to be greater than 100 when used at a concentration of 10% as a UV filter in all cosmetic products, suggesting that its use as a cosmetic ingredient is safe under the current usage conditions.</p>

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Safety assessment of methylene bis-benzotriazolyl tetramethylbutylphenol, a UV filter in cosmetics

  • 期刊论文

  • 发表日期：

    2026年5月16日

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  • Minhyuk Kim,
  • Su Bin Kim,
  • Jung Dae Lee,
  • Taehyung Yoon,
  • Kyu-Bong Kim,
  • Seung Jun Kwack,
  • Joo Young Lee

摘要

Methylene bis-benzotriazolyl tetramethylbutylphenol (MBBT) is a UV filter and UV absorber used in cosmetics. In this study, the acute toxicity, repeated dose toxicity, skin irritation, ocular irritation, skin sensitization, reproductive, and developmental toxicity, genotoxicity, carcinogenicity, toxicokinetics, and dermal absorption of MBBT were evaluated. The oral and dermal LD50s of non-nanoform MBBT in rats were 2 g/kg. The LC50 of nanoform MBBT in rats was 0.488 mg/L. Neither 20% nanoform MBBT nor 65% non-nanoform MBBT caused skin irritation. Moreover, 50% nanoform MBBT did not cause ocular irritation and 30% non-nanoform MBBT did not induce skin sensitization. In reproductive and developmental toxicity studies in rats, neither male nor pregnant female rats nor fetuses exhibited adverse effects after receiving up to 1000 mg/kg/day of non-nanoform MBBT. In vitro bacterial reverse mutation assays, micronucleus tests, and gene mutation assays, as well as in vivo micronucleus assays, yielded negative results. The NOAEL of MBBT was determined to be 1000 mg/kg/day (the highest dose tested) on the basis of the results of a 90-day repeated dermal toxicity study in rats. The NOAEL was optimized to the internal dose by applying a dermal absorption rate of 5.922%, resulting in a systemic point of departure (PODsys) for MBBT of 59.22 mg/kg/day. The systemic exposure dose was calculated to be 0.0136 mg/kg/day. The margin of safety of MBBT was calculated to be greater than 100 when used at a concentration of 10% as a UV filter in all cosmetic products, suggesting that its use as a cosmetic ingredient is safe under the current usage conditions.