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Updated: Nov 21, 2025

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Draize human repeat insult patch test (HRIPT): Seven decades of pitfalls and progress.

Jordan L Bormann¹, Howard I Maibach²

¹University of South Dakota, Sanford School of Medicine, Sioux Falls, SD, 57105, USA.

Regulatory Toxicology and Pharmacology : RTP

|January 18, 2021

Summary

Standardizing the human repeat insult patch test (HRIPT) is crucial for accurately predicting allergic contact dermatitis. Current protocols vary, hindering reliable risk assessment for chemicals and drugs.

Keywords:

Allergic contact dermatitis Contact dermatitis Draize human repeat insult patch testing

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Area of Science:

Dermatology
Toxicology
Immunology

Background:

Allergic contact dermatitis (ACD) is a significant health concern for patients and workers.
Animal models and human patch testing have been used for over a century to predict ACD potential.
The human repeat insult patch test (HRIPT) is a key method derived from early animal studies.

Purpose of the Study:

To review major Draize-derived HRIPT protocols.
To identify variations and lack of standardization in HRIPT methods.
To propose a standardized HRIPT protocol for improved chemical risk assessment.

Main Methods:

Literature search of major Draize-derived HRIPT protocols.
Analysis of protocol differences and standardization issues.
Synthesis of best practices for a potential standardized HRIPT.

Main Results:

Significant variations exist between different HRIPT protocols.
Lack of international standardization complicates generalization of HRIPT study results.
Post-Draize modifications have improved HRIPT usefulness.

Conclusions:

Standardization of the HRIPT is necessary for reliable prediction of allergic contact dermatitis potential.
A standardized HRIPT protocol would enhance quantitative risk assessment for chemicals and drugs.
Implementing a standardized HRIPT procedure is recommended for regulatory and research purposes.