Analysis of the Local Lymph Node Assay (LLNA) variability for assessing the prediction of skin sensitisation potential and potency of chemicals with non-animal approaches

Toxicology in Vitro

Volumn 34, Issue , 2016, Pages 220-228

  Dumont, Coralie ^a   Barroso, João ^a   Matys, Izabela ^a   Worth, Andrew ^a   Casati, Silvia ^a  

^a JOINT RESEARCH CENTRE   (Italy)

Author keywords

Alternative methods; ECETOC; GHS CLP; LLNA variability; Validation

Indexed keywords

1 BROMOHEXADECANE; 1 CHLORO 2,4 DINITROBENZENE; 1,2 BENZISOTHIAZOLIN 3 ONE; 1,4 DIHYDROQUINONE; 2 AMINOPHENOL; 2,4 DINITROBENZENE SULFONIC ACID; ACETONE; ALCOHOL; ANILINE; BENZOCAINE; BENZOYL PEROXIDE; CHEMICAL COMPOUND; CINNAMALDEHYDE; COBALT CHLORIDE; DICHROMATE POTASSIUM; DIPHENCYPRONE; DODECYL SULFATE SODIUM; ETHYL 2 (HYDROXYMETHYL) 1,3 PROPANEDIOL TRIACRYLATE; FORMALDEHYDE; GLUTARALDEHYDE; N,N DIMETHYLFORMAMIDE; OLIVE OIL; OXALIC ACID; PHENYL BENZOATE; PHENYLENEDIAMINE; PHTHALIC ACID DIETHYL ESTER; SOLVENT; TETRAMETHYLTHIURAM DISULPHIDE; TRIMELLITIC ANHYDRIDE; UNCLASSIFIED DRUG; UNINDEXED DRUG; HAPTEN;

ARTICLE; CHEMICAL ANALYSIS; CLASSIFICATION; DATA BASE; HAZARD ASSESSMENT; HEALTH HAZARD; LOCAL LYMPH NODE ASSAY; NON ANIMAL TEST; NONHUMAN; PREDICTION; RELIABILITY; SKIN SENSITIZATION; STANDARD; VALIDATION PROCESS; ANIMAL; ANIMAL TESTING ALTERNATIVE; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; SKIN ALLERGY;

ANIMAL TESTING ALTERNATIVES; ANIMALS; DERMATITIS, ALLERGIC CONTACT; HAPTENS; LOCAL LYMPH NODE ASSAY; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 84973126897     PISSN: 08872333     EISSN: 18793177     Source Type: Journal    
DOI: 10.1016/j.tiv.2016.04.008     Document Type: Article

References (39)

1. Adriaens E., Barroso J., Eskes C., Hoffmann S., McNamee P., Alépée N., Bessou-Touya S., De Smedt A., De Wever B., Pfannenbecker U., Tailhardat M., Zuang V. Retrospective analysis of the Draize test for serious eye damage/eye irritation: importance of understanding the in vivo endpoints under UN GHS/EU CLP for the development and evaluation of in vitro test methods. Arch. Toxicol. 2014, 88:701-723.
2. Anderson S.E., Siegel P.D., Meade B.J. The LLNA: a brief review of recent advances and limitations. J. Allergy 2011, 2011, article ID 424203, 10 pages.
3. Asturiol D., Casati S., Worth A. Consensus classification tree model for skin sensitisation hazard prediction. Toxicol. in Vitro 2016, (Submitted for publication).
4. Barroso J., Pfannenbecker U., Adriaens E., Alépée N., Cluzel M., De Smedt A., Hibatallah J., Klaric M., Mewes K.R., Millet M., Templier M., McNamee P. Cosmetics Europe compilation of historical serious eye damage/eye irritation in vivo data analysed by drivers of classification to support the selection of chemicals for development and evaluation of alternative methods/strategies: the Draize eye test Reference Database (DRD). Arch. Toxicol. 2016, (in press).
5. Basketter D.A., Gerberick G.F., Kimber I. Skin sensitisation, vehicle effects and the local lymph node assay. Food Chem. Toxicol. 2001, 39:621-627.
6. Basketter D.A., Evans P., Fielder R.J., Gerberick G.F., Dearman R.J., Kimber I. Local lymph node assay - validation, conduct and use in practice. Food Chem. Toxicol. 2002, 40:593-598.
7. Basketter D.A., Alépée N., Ashikaga T., Barroso J., Gilmour N., Goebel C., Hibatallah J., Hoffman S., Kern P., Martinozzi-Teissier S., Maxwell G., Reisinger K., Sakaguchi H., Schepky A., Tailhardat M., Templier M. Categorization of chemicals according to their relative human skin sensitizing potency. Dermatitis 2014, 25(1):11-21.
8. Bauch C., Kolle S.N., Ramirez T., Eltze T., Fabian E., Mehling A., Teubner W., van Ravenzwaay B., Landsiedel R. Putting the parts together: combining in vitro methods to test for skin sensitizing potentials. Regul. Toxicol. Pharmacol. 2012, 63:489-504.
9. Casati S., Aeby P., Kimber I., Maxwell G., Ovigne J.M., Roggen E., Rovida C., Tosti L., Basketter D. Selection of chemicals for the development and evaluation of in vitro methods for skin sensitisation testing. Altern. Lab. Anim 2009, 37(3):305-312.
10. Cottrez F., Boitel E., Auriault C., Aeby P., Groux H. Genes specifically modulated in sensitized skins allow the detection of sensitizers in a reconstructed human skin model. Development of the SENS-IS assay. Toxicol. in Vitro 2015, 29:787-802.
11. ECETOC Technical Report No.87. Contact Sensitisation: Classification According to Potency 2003, Online at. http://www.ecetoc.org/technical-reports.
12. EURL ECVAM Direct Peptide Reactivity Assay (DPRA) ECVAM Validation Study Report Online at. https://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-recommendations/files-dpra/DPRA%20Validation%20Study%20Report.pdf.
13. EURL ECVAM EURL ECVAM Recommendation on the Direct Peptide Reactivity Assay (DPRA) for Skin Sensitisation Testing. JRC Scientific and Policy Reports 2013, Online at. https://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-recommendations/eurl-ecvam-recommendation-on-the-direct-peptide-reactivity-assay-dpra.
14. EURL ECVAM EURL ECVAM Recommendation on the KeratinoSens™ Assay for Skin Sensitisation Testing Online at. https://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-recommendations/recommendation-keratinosens-skin-sensitisation.
15. EURL ECVAM EURL ECVAM Recommendation on the Human Cell Line Activation Test (h-CLAT) for Skin Sensitisation Testing Online at. https://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-recommendations.
16. EURL ECVAM Human Cell Line Activation Test (h-CLAT) Validation Study Report Online at. https://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-recommendations/eurl-ecvam-recommendation-on-the-human-cell-line-activation-test-h-clat-for-skin-sensitisation-testing.
17. European Commission CLP regulation (EC) no. 1272/2008 for "classification, labelling and packaging of substances and mixtures". Off. J. Eur. Union 2008, L353:1-1355.
18. Gibbs S., Corsini E., Spiekstra S.W., Galbiati V., Fuchs H.W., DeGeorge G., Troese M., Hayden P., Deng W., Roggen E. An epidermal equivalent assay for identification and ranking potency of contact sensitizers. Toxicol. Appl. Pharmacol. 2013, 272:529-541.
19. Hirota M., Fukui S., Okamoto K., Kurotani S., Imai N., Fujishiro M., Kyotani D., Kato Y., Kasahara T., Fujita M., Toyoda A., Sekiya D., Watanabe S., Seto H., Takenouchi O., Ashikaga T., Miyazawa M. Evaluation of combinations of in vitro sensitization test descriptors for the artificial neural network-based risk assessment model of skin sensitization. J. Appl. Toxicol. 2015, 35(11):1333-1347.
20. Hoffmann S. LLNA variability: an essential ingredient for a comprehensive assessment of non-animal skin sensitization test methods and strategies. ALTEX 2015, 32(4):379-383.
21. Jaworska J., Dancik Y., Kern P., Gerberick F., Natsch A. Bayesian integrated testing strategy to assess skin sensitization potency: from theory to practice. J. Appl. Toxicol. 2013, 33:1353-1364.
22. Jaworska J., Natsch A., Ryan C., Strickland J., Ashikaga T., Miyazawa M. Bayesian integrated testing strategy (ITS) for skin sensitization potency assessment: a decision support system for quantitative weight of evidence and adaptive testing strategy. Arch. Toxicol. 2015, 89(12):2355-2383.
23. Johansson H., Lindstedt M. Prediction of skin sensitizers using alternative methods to animal experimentation. Basic Clin. Pharmacol. Toxicol. 2014, 115:110-117.
24. Johansson H., Rydnert F., Kühnl J., Schepky A., Borrebaek C., Lindstedt M. Genomic allergen rapid detection in-house validation - a proof of concept. Toxicol. Sci. 2014, 139(2):362-370.
25. Jowsey I.R., Clapp C.J., Safford B., Gibbons B.T., Basketter D.A. The impact of vehicle on the relative potency of skin-sensitizing chemicals in the local lymph node assay. Cutan. Ocul. Toxicol. 2008, 27(2):67-75.
26. Maxwell G., MacKay C., Cubberley R., Davies M., Gellatly N., Glavin S., Gouin T., Jacquoilleot S., Moore C., Pendlington R., Saib O., Sheffield D., Stark R., Summerfield V. Applying the skin sensitisation adverse outcome pathway (AOP) to quantitative risk assessment. Toxicol. in Vitro 2014, 28(1):8-12.
27. Natsch A., Emter R., Gfeller H., Haupt T., Ellis G. Predicting skin sensitizer potency based on in vitro data from KeratinoSens and kinetic peptide binding: global versus domain-based assessment. Toxicol. Sci. 2015, 143(2):319-332.
28. Nukada Y., Miyazawa M., Kazutoshi S., Sakaguchi H., Nishiyama N. Data integration of non-animal tests for the development of a test battery to predict the skin sensitizing potential and potency of chemicals. Toxicol. in Vitro 2013, 27:609-618.
29. OECD OECD test guideline 429 for the testing of chemicals. Skin Sensitisation: Local Lymph Node Assay 2009, Online at. http://www.oecd-ilibrary.org/environment/test-no-429-skin-sensitisation_9789264071100-en.
30. OECD The adverse outcome pathway for skin sensitisation initiated by covalent binding to proteins. Series on Testing and Assessment No. 168 2012, Online at. http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO(2012)10/PART1&docLanguage=En.
31. OECD OECD test guideline 442C for the testing of chemicals. In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA) 2015, Online at:. http://www.oecd-ilibrary.org/environment/test-no-442c-in-chemico-skin-sensitisation_9789264229709-en.
32. OECD OECD Test Guideline 442D for the Testing of Chemicals: In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method Online at. http://www.oecd-ilibrary.org/environment/test-no-442d-in-vitro-skin-sensitisation_9789264229822-en.
33. Piroird C., Ovigne J.M., Rousset F., Martinozzi-Teissier S., Gomes C., Cotovio J., Alépée N. The myeloid skin sensitization test (U-SENS) addresses the activation of dendritic cell event in the adverse outcome pathway for skin sensitization. Toxicol. in Vitro 2015, 29:901-916.
34. Ramirez T., Stein N., Aumann A., Remus T., Edwards A., Norman K.G., Ryan C., Bader J.E., Fehr M., Burleson F., Foertsch L., Wang X., Gerberick F., Beilstein P., Hoffmann S., Mehling A., van Ravenzwaay B., Landsiedel R. Intra- and inter-laboratory reproducibility and accuracy of the LuSens assay: a reporter gene-cell line to detect keratinocyte activation by skin sensitizers. Toxicol. in Vitro 2016, 32:278-286.
35. Reisinger K., Hoffmann S., Alépée N., Ashikaga T., Barroso J., Elcombe C., Gellatly N., Galbiati V., Gibbs S., Groux H., Hibatallah J., Keller D., Kern P., Klaric M., Kolle S., Kuehnl J., Lambrechts N., Lindstedt M., Millet N., Martinozzi-Teissier S., Natsch A., Petersohn D., Pike I., Sakaguchi H., Schepky A., Tailhardat M., Templier M., van Vliet E., Maxwell G. Systematic evaluation of non-animal test methods for skin sensitisation safety assessment. J. Appl. Toxicol. 2015, 35(11):1318-1332. (Epub 2015 Mar 29). (2015;Nov). 10.1002/jat.3127.
36. Takenouchi O., Fukui S., Okamoto K., Kurotani S., Imai N., Fujishiro M., Kyotani D., Kato Y., Kasahara T., Fujita M., Toyoda A., Sekiya D., Watanabe S., Seto H., Hirota M., Ashikaga T., Miyazawa M. Test battery with the human cell line activation test, direct peptide reactivity assay and DEREK based on a 139 chemical data set for predicting skin sensitizing potential and potency of chemicals. J. Appl. Toxicol. 2015, 35(11):1318-1332.
37. UN Globally harmonized system of classification and labelling of chemicals (GHS). Sixth revised version 2015, Online at. http://www.unece.org/trans/danger/publi/ghs/ghs_rev06/06files_e.html.
38. Urbisch D., Mehling A., Guth K., Ramirez T., Honarvar N., Kolle S., Landsiedel R., Jaworska J., Kern P.S., Gerberick F., Natsch A., Emter R., Ashikaga T., Miyazawa M., Sakaguchi H. Assessing skin sensitization hazard in mice and men using non-animal test methods. Regul. Toxicol. Pharmacol. 2015, 71:337-351.
39. Van der Veen J.W., Rorije E., Emter R., Natsch A., van Loveren H., Ezendam J. Evaluating the performance of integrated approaches for hazard identification of skin sensitizing chemicals. Regul. Toxicol. Pharmacol. 2014, 69:371-379.