Dermal toxicity, dermal irritation, and delayed contact sensitization evaluation of oil body linked oleosin-hEGF microgel emulsion via transdermal drug delivery for wound healing. (2nd January 2021)

• Record Type: Journal Article
• Authors: Lan, Xinxin; Zhou, Tingting; Dong, Yue; Li, Yuyan; Liu, Xinyu; Qiang, Weidong; Liu, Yan; Guo, Yongxin; Noman, Muhammad; Li, Jing; Du, Linna; Li, Xiaokun; Yang, Jing
• Is Part Of: Cutaneous and ocular toxicology. Volume 40:Number 1(2021)
• Page Start: 45
• Page End: 53
• Publication Date: 2021-01-02
• Subjects: Oil body-linked oleosin-hEGF -- microgel emulsion -- dermal toxicity -- irritation -- sensitization; Dermatotoxicology -- Periodicals; Ocular toxicology -- Periodicals; Ocular pharmacology -- Periodicals; Dermatopharmacology -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1080/15569527.2021.1874008
• Languages: English
• ISSNs: 1556-9527

Abstract

Abstract: Objective: The expression of therapeutic proteins in plant oil body bioreactors has attracted much attention. But its safety is not yet clear. This article determines the risk of safety after using the drug. Methods: The oil body-linked oleosin-hEGF microgel emulsion (OBEME) was prepared by mixing the xanthan gum with suitable concentrations in an appropriate proportion. Skin irritation and sensitization reaction were investigated in rats and guinea pigs using OBEME as test article. Results: The OBEME did not produce dermal erythema/eschar or oedema responses. The dermal subacute and subchronic toxicity of OBEME were evaluated in accordance with OECD guidelines. Compared with the control group, the basic physical signs, such as weight, feed, drinking, excretion, and behaviour of experimental animals, were not abnormal. In addition, no abnormality was found in haematological parameters, biochemical indexes, relative organ weight, and histopathological observation of organs, and there was no significant difference compared with normal saline treatment group. Therefore, we conclude that OBEME has no toxic effects and is safe and reliable to be used for topical application.