Title
International ring trial of the epidermal equivalent sensitizer potency assay: Reproducibility and predictive-capacity
Author
Teunis, M.A.T.
Spiekstra, S.W.
Smits, M.
Adriaens, E.
Eltze, T.
Galbiati, V.
Krul, C.A.M.
Landsiedel, R.
Pieters, R.
Reinders, J.
Roggen, E.
Corsini, E.
Gibbs, S.
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-1(IL-12x). 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-12x) 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.
Subject
Healthy Living
Themalijn
Biomedical Innovation
Health
Healthy Living
Epidermal equivalent
In vitro
NOEL
Sensitizer potency
1 chloro 2,4 dinitrobenzene
2 mercaptobenzothiazole
allergen
benzocaine
cinnamaldehyde
citral
cobalt chloride
formaldehyde
interleukin 1alpha
isoeugenol
oxazolone
phenylenediamine
accuracy
assay
controlled study
cytotoxicity
epidermal equivalent sensitizer potency assay
reproducibility
skin sensitization
To reference this document use:
http://resolver.tudelft.nl/uuid:ee858182-07fd-446b-bc75-c8d25510194d
DOI
https://doi.org/10.14573/altex.1308021
TNO identifier
503450
Source
ALTEX, 31 (3), 251-268
Document type
article