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A triangular approach for the validation of new approach methods for skin sensitization
Andreas Natsch1, Robert Landsiedel2, Susanne N Kolle2
1Fragrances S&T, Ingredients Research, Givaudan Schweiz AG, Kemptthal, Switzerland.
ALTEX
|July 11, 2021
Summary
The "2 out of 3" defined approach (2o3 DA) for skin sensitization accurately predicts human hazard, outperforming the traditional local lymph node assay (LLNA). This emphasizes a comprehensive data approach for regulatory acceptance.
Area of Science:
- Toxicology
- Regulatory Science
- In Vitro Methods
Background:
- New Approach Methods (NAMs) and integrated approaches like Defined Approaches (DAs) require robust reference data for development and regulatory acceptance.
- Human skin sensitization data is relatively abundant, allowing for comparison with animal studies like the Local Lymph Node Assay (LLNA).
- The OECD has focused on human and LLNA data for validation, leading to the development of the
- Purpose of the Study
- Main Methods
- Main Results
- Conclusions
Purpose of the Study:
- To review the predictivity of the
- Main Methods
- Main Results
- Conclusions
Main Methods:
- The study reviewed the predictivity of the
- Main Results
- Conclusions
Main Results:
- The
- Conclusions
Conclusions:
- The
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