Global Cosmetic Compliance
Intelligence & Solutions
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:
/
Document
Language Source Title Access
ZH
Official In Chemico Skin Sensitisation: Kinetic Direct Peptide Reactivity Assay (kDPRA) (Draft) and Drafting Instructions
In Chemico Skin Sensitisation: Kinetic Direct Peptide Reactivity Assay (kDPRA) (Draft) and Drafting Instructions
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Summary

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