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In Chemico Skin Sensitisation: Kinetic Direct Peptide Reactivity Assay (kDPRA) (Draft) and Drafting Instructions

Local Title
体外化学法皮肤变态反应 动力学直接多肽反应试验方法（征求意见稿）及起草说明
Country/Region
Chinese Mainland
Competent Authority
National Institutes for Food and Drug Control
Type
Regulation
Status
Draft
Release Date
2025-01-22
Implementation Date
/
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In Chemico Skin Sensitisation: Kinetic Direct Peptide Reactivity Assay (kDPRA) (Draft) and Drafting Instructions
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On January 22, 2025, China National Institutes for Food and Drug Control (NIFDC) released nine testing methods for public consultation, with feedback accepted until February 21, 2025. One of the methods is the In Chemico Skin Sensitisation: Kinetic Direct Peptide Reactivity Assay (kDPRA) (Draft).

This method presents the fundamental principles, requirements, and procedures for kDPRA. It serves for the toxicological test of cosmetic ingredients, and is suitable for evaluating the potential skin sensitization of single substances, as well as multi-component substances and mixtures with known compositions and contents. 

User Guide