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<p>Research into the use of cannabidiol (CBD) for medical purposes is permitted within Korea in the hemp regulation-free zone. To develop CBD as a topical over-the-counter (OTC) drug, we obtained an active pharmaceutical ingredient (API)-grade CBD isolate (purity ≥ 99.5%) from <i>Cannabis sativa</i> cultivated on a smart farm in the hemp regulation-free zone. Then, we aimed to assess the acute and local toxicity of the isolated raw CBD and its topical ointment formulation. We evaluated the single-dose oral and dermal toxicity of CBD in Sprague–Dawley rats and conducted primary skin and eye irritation tests on the CBD ointment in New Zealand White rabbits. We also employed in vitro models of reconstructed human epidermis (RhE) and cornea-like epithelium (RhCE) to evaluate the skin and eye irritation or corrosion of CBD and ointment. In addition, skin absorption tests for CBD and ointment were performed using a skin-like synthetic membrane with a Franz diffusion cell system. The median lethal dose was determined to be over 2000&#xa0;mg/kg body weight. The CBD formulation was a slight irritant, but this was attributed to the vehicle ointment, and all test materials were classified as non-irritant to the skin and eyes. CBD showed the percutaneous penetration in the skin absorption test. The results indicate that CBD demonstrates favorable safety profiles as an active ingredient both in its raw form and as topical formulations, showing non-irritant properties in skin and eye irritation tests, as well as non-toxic outcomes in acute oral and dermal toxicity tests in this study.</p>

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Evaluation of local and acute toxicity, and skin absorption of cannabidiol isolated from Cannabis sativa cultivated in Korea

  • 期刊论文

  • 发表日期：

    2026年7月27日

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  • Minseo Kwon,
  • Geun Hyeong Kim,
  • Jeong-Min Lee,
  • Yoon Gyung Kwon,
  • Tae Won Kwak,
  • Jeong Ho Park,
  • Su-Hyun Nam,
  • Byoungjun Park

摘要

Research into the use of cannabidiol (CBD) for medical purposes is permitted within Korea in the hemp regulation-free zone. To develop CBD as a topical over-the-counter (OTC) drug, we obtained an active pharmaceutical ingredient (API)-grade CBD isolate (purity ≥ 99.5%) from Cannabis sativa cultivated on a smart farm in the hemp regulation-free zone. Then, we aimed to assess the acute and local toxicity of the isolated raw CBD and its topical ointment formulation. We evaluated the single-dose oral and dermal toxicity of CBD in Sprague–Dawley rats and conducted primary skin and eye irritation tests on the CBD ointment in New Zealand White rabbits. We also employed in vitro models of reconstructed human epidermis (RhE) and cornea-like epithelium (RhCE) to evaluate the skin and eye irritation or corrosion of CBD and ointment. In addition, skin absorption tests for CBD and ointment were performed using a skin-like synthetic membrane with a Franz diffusion cell system. The median lethal dose was determined to be over 2000 mg/kg body weight. The CBD formulation was a slight irritant, but this was attributed to the vehicle ointment, and all test materials were classified as non-irritant to the skin and eyes. CBD showed the percutaneous penetration in the skin absorption test. The results indicate that CBD demonstrates favorable safety profiles as an active ingredient both in its raw form and as topical formulations, showing non-irritant properties in skin and eye irritation tests, as well as non-toxic outcomes in acute oral and dermal toxicity tests in this study.