Predicting Immune Risks: An In-depth Analysis of OECD TG 406 Skin Sensitization
During product R&D and regulatory compliance, ensuring a product does not cause immediate "irritation" is only half the battle. We must also prevent Delayed-Type Hypersensitivity—an immune response triggered after repeated exposure. OECD TG 406 (Skin Sensitization) is the global benchmark for evaluating the potential of a substance to cause Allergic Contact Dermatitis (ACD).
What is OECD TG 406?
OECD TG 406 identifies whether a substance acts as a "Sensitizer." Unlike acute irritation, sensitization involves the immune system and typically manifests after the second or subsequent exposure. This guideline covers two classic animal models:
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Guinea Pig Maximization Test (GPMT): Utilizes intradermal injections with an adjuvant to enhance the immune response. It is known for its high sensitivity and wide regulatory acceptance.
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Buehler Test: Mimics repeated topical exposure, often used for testing finished products or ingredients intended for topical application.Why is TG 406 Essential for Your Product?
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Uncovering "Invisible" Risks: Many substances show no reaction upon first contact but cause severe redness or itching after repeated use. TG 406 helps eliminate these hazards pre-market.
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Core Requirement of ISO 10993-10: For the vast majority of medical devices (consumables, implants), skin sensitization data is a mandatory safety requirement.
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Global Regulatory Passport: A report generated under OECD GLP compliance is a cornerstone of your technical file for TFDA, FDA, and MDR submissions.
- Test species: Narl：HARTLEY Guinea pig
- The objective of this study is evaluation of the skin sensitization caused by test substance in guinea pig. This study can be executed in an adjuvant tests or non-adjuvant tests, according to the requirements of customers. No matter which types of tests, the guinea pigs will be be subjected to twice induction and once challenge. The changes of dermal reactions will be graded and recorded in accordance with the guideline of OECD TG-406.
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