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21:16
An In Vitro Skin Irritation Test (SIT) using the EpiDerm Reconstructed Human Epidermal (RHE) Model
Published on: July 13, 2009
The human repeated insult patch test in the 21st century: a commentary
1DABMEB Consultancy Ltd., Sharnbrook, UK. david.basketter@ukonline.co.uk
Cutaneous and Ocular Toxicology
|June 12, 2009
Summary
The human repeated insult patch test (HRIPT) is an outdated method for evaluating skin sensitizers. While rarely justifiable for specific scientific reasons, most HRIPTs lack ethical and scientific merit.
Area of Science:
- Dermatology
- Toxicology
- Cosmetic Science
Background:
- The human repeated insult patch test (HRIPT) remains in use for skin sensitizer safety evaluation.
- Significant ethical and scientific validity concerns surround the HRIPT.
Purpose of the Study:
- To critically review the HRIPT, focusing on ethical considerations.
- To assess the scientifically meaningful contributions and limitations of HRIPT in safety evaluations.
Main Methods:
- Commentary and review of existing literature and practices regarding the HRIPT.
- Analysis of ethical implications and scientific justification for HRIPT use.
Main Results:
- HRIPTs can be ethically and scientifically justifiable only in rare cases with specific rationales, such as substantiating no-effect levels.
- The potential to induce sensitization in volunteers necessitates extreme caution and rarity of HRIPT application.
- The vast majority of HRIPTs lack scientific justification and merit.
Conclusions:
- HRIPTs should be exceptionally rare, reserved for situations where benefits clearly outweigh the risks of inducing sensitization.
- Most current HRIPT applications for skin sensitization risk assessment are scientifically unwarranted and ethically questionable.
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