Journal of Pharmaceutical and Biomedical Sciences

Safety Evaluation of GP-EGF Lyophilised Powder

Zhang Bei-Bei, He Jin-Lian, Bei Yu, Zhang You-Ying, Huang Ya-Dong, Xiang Qi

Abstract


To clarify the safe risks related to the use of GP-EGF lyophilised powder (GELP), acute toxicity test, dermal allergy test, dermal irritation test, and subchronic toxicological test were evaluated according to the guideline for hygienic standard for cosmetics (2007). In acute toxicity tests using guinea pigs, there was no treatment-related mortality, clinical signs of toxicity, body weight changes and gross findings at a dose level of 2,000 mg·kg?1·d?1. Similarly, dermal allergy test using guinea pigs and dermal irritation test using rabbits revealed no mortality, clinical signs of toxicity and a corrosion reaction on the skin. In the subchronic study, no death or clinical signs, or abnormal haematological, biochemical and histopathological changes were found in rats after receiving, by the concentration in 56 mg·mL?1·d?1, 112 mg·mL?1·d?1 of GELP for 90 days. Our findings indicated that GELP is relatively safe since it did not induce an acute toxicity test, dermal allergy test, dermal irritation test and subchronic toxicological test.

Keywords


EGF, GP-EGF lyophilised powder (GELP), acute toxicity test, dermal allergy test, dermal irritation test, subchronic toxicological test

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