Core Purpose
Irritation: Direct physical/chemical damage to the skin caused by the product (e.g., erythema, stinging, typically appearing rapidly after contact and dose-dependent);
Sensitization: An immune system response triggered by product ingredients (a Type IV hypersensitivity reaction), requiring repeated contact to "induce" immune system sensitization; allergic symptoms (e.g., erythema, papules, vesicles, etc.) appear only upon re-exposure and are related to the individual's immune status.
Test Procedure
- Induction Phase (Sensitization Induction)
3-4 times per week, patches containing the test product are applied to the skin on the volunteer's back or inner upper arm (dosage adjusted according to product type), with each application lasting 24-48 hours, repeated at intervals of 1-2 days.
Continues for 2-3 weeks, aiming to allow the skin to repeatedly contact potential allergens and induce a sensitized state in the immune system.
- Rest Phase
After induction, product contact is discontinued for a 10-14 day rest period to allow the immune system to complete the establishment of "sensitization memory."
- Challenge Phase (Allergic Reaction Verification)
The test product is reapplied to the volunteer's skin (usually a new, previously unexposed site), removed after 24-48 hours, and then observed for 48-72 hours (in some cases extended to 1 week).
If a clear allergic reaction occurs (e.g., erythema + papules, vesicles), it is determined as "sensitization positive," indicating that the product may pose a sensitization risk.
Result Interpretation
Negative (no reaction);
Doubtful reaction (mild erythema);
Weak positive (definite erythema + mild papules);
Strong positive (erythema + papules + vesicles/exudation).