Back to Search
Start Over
International ring trial of the epidermal equivalent sensitizer potency assay: reproducibility and predictive-capacity.
- Source :
-
ALTEX [ALTEX] 2014; Vol. 31 (3), pp. 251-68. Date of Electronic Publication: 2014 Feb 17. - Publication Year :
- 2014
-
Abstract
- This study describes the international ring trial of the epidermal-equivalent (EE) sensitizer potency assay. This assay does not distinguish a sensitizer from a non-sensitizer, but may classify known skin sensitizers according to their potency. It assesses the chemical concentration resulting in 50% cytotoxicity (EE-EC50) or the 2-fold increase in IL-1α (IL-1α2x). Four laboratories received 13 coded sensitizers. Reproducible results were obtained in each laboratory. A binary prediction model, EC50≥7 mg/ml=weak to moderate sensitizer and EC50<7 mg/ml=strong to extreme sensitizer had an accuracy of 77%. A superior EE (EC50 and IL-1α2x) correlation was observed with human in vivo DSA05 data compared to LLNA-EC3 data. Human in vivo NOEL and LLNA-EC3 data correlated to a similar extent to in vitro EE data. Our results indicate that this easily transferable EE potency assay is suitable for testing chemical allergens of unknown potencies and may now be ready for further validation, providing complementary potency information to other assays already undergoing validation for assessing skin sensitization potential.
- Subjects :
- Allergens chemistry
Animal Testing Alternatives
Animals
Cells, Cultured
Epidermis immunology
Humans
In Vitro Techniques
Interleukin-18 immunology
Interleukin-18 metabolism
Local Lymph Node Assay
Mice
Predictive Value of Tests
Reproducibility of Results
Toxicity Tests methods
Allergens adverse effects
Dermatitis, Allergic Contact etiology
Epidermis drug effects
Subjects
Details
- Language :
- English
- ISSN :
- 1868-8551
- Volume :
- 31
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- ALTEX
- Publication Type :
- Academic Journal
- Accession number :
- 24535238
- Full Text :
- https://doi.org/10.14573/altex.1308021