Accounting for data variability, a key factor in in vivo/in vitro relationships: application to the skin sensitization potency (in vivo LLNA versus in vitro DPRA) example

Journal of Applied Toxicology

Volumn 36, Issue 12, 2016, Pages 1568-1578

  Dimitrov, S ^a   Detroyer, A ^b   Piroird, C ^b   Gomes, C ^b   Eilstein, J ^b   Pauloin, T ^b   Kuseva, C ^a   Ivanova, H ^a   Popova, I ^a   Karakolev, Y ^a   Ringeissen, S ^b   Mekenyan, O ^a  

^a ASSEN ZLATAROV UNIVERSITY   (Bulgaria)

^b L'Oreal R I   (France)

Author keywords

alternative methods; DPRA; EU cosmetics regulation; in vitro; in vivo; LLNA; skin sensitization

Indexed keywords

ANIMAL TISSUE; ARTICLE; CASE STUDY; DIRECT PEPTIDE REACTIVITY ASSAY; IN VITRO STUDY; IN VIVO STUDY; LOCAL LYMPH NODE ASSAY; MOLECULAR WEIGHT; MOUSE; NONHUMAN; NUCLEOPHILICITY; PEPTIDE ANALYSIS; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; PROBABILITY; QUANTITATIVE STRUCTURE ACTIVITY RELATION; REPRODUCIBILITY; SKIN SENSITIZATION; STATISTICAL ANALYSIS;

EID: 84991262970     PISSN: 0260437X     EISSN: 10991263     Source Type: Journal    
DOI: 10.1002/jat.3318     Document Type: Article

References (33)

1. Adler S, Basketter D, Creton S, Pelkonen O, van Benthem J, Zuang V, Andersen KE, Angers-Loustau A, Aptula A, Bal-Price A, Benfenati E, Bernauer U, Bessems J, Bois FY, Boobis A, Brandon E, Bremer S, Broschard T, Casati S, Coecke S, Corvi R, Cronin M, Daston G, Dekant W, Felter S, Grignard E, Gundert-Remy U, Heinonen T, Kimber I, Kleinjans J, Komulainen H, Kreiling R, Kreysa J, Leite SB, Loizou G, Maxwell G, Mazzatorta P, Munn S, Pfuhler S, Phrakonkham P, Piersma A, Poth A, Prieto P, Repetto G, Rogiers V, Schoeters G, Schwarz M, Serafimova R, Tähti H, Testai E, van Delft J, van Loveren H, Vinken M, Worth A, Zaldivar J-M. 2010. Alternative (non-animal) methods for cosmetics testing: current status and future prospects – 2010. Arch. Toxicol. 85: 367–485.
2. Anderson SE, Siegel PD, Meade BJ. 2011. The LLNA: A brief review of recent advances and limitations. J. Allergy (Cairo) 2011: 1–10.
3. Basketter DA, Cadby P. 2004. Reproducible prediction of contact allergenic potency using the local lymph node assay. Contact Dermatitis 50: 15–17.
4. Basketter DA, Gerberick GF, Kimber I. 2007. The local lymph node assay and the assessment of relative potency: status of validation. Contact Dermatitis 57: 70–75.
5. Basketter DA, Lea LJ, Cooper K, Stocks J, Dickens A, Pate I, Dearman RJ, Kimber I. 1999. Threshold for classification as a skin sensitizer in the Local lymph node assay: a statistical evaluation. Food Chem. Toxicol. 37: 1167–1174.
6. Dearman RJ, Betts CJ, Farr C, McLaughlin J, Berdasco N, Wiench K, Kimber I. 2007. Comparative analysis of skin sensitization potency of acrylates (methyl acrylate, ethyl acrylate, butyl acrylate, and ethylhexyl acrylate) using the local lymph node assay. Contact Dermatitis 57: 242–247.
7. Dearman RJ, Wright ZM, Basketter DA, Ryan CA, Gerberick GF, Kimber I. 2001. The suitability of hexyl cinnamic aldehyde as a calibrant for the murine local lymph node assay. Contact Dermatitis 44: 357–361.
8. ECVAM. 2000. Joint Research Centre (JRC). European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). https://eurl-ecvam.jrc.ec.europa.eu/validation-regulatory-acceptance/skin-corrosion-docs/EpiDerm_statement.pdf [23 March 2016].
9. ECVAM. 2008. Joint Research Centre (JRC). European Centre for the Validation of Alternative Methods (ECVAM).https://eurl-ecvam.jrc.ec.europa.eu/validation-regulatory-acceptance/docs-skin-sen/ECVAM%20LLNA%20Performance%20Standards-Sec.pdf [23 March 2016].
10. ECVAM. 2013. Joint Research Centre (JRC). European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). https://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-recommendations/filesdpra/EURL_ECVAM_Recommendation_DPRA_2013.pdf [23 March 2016].
11. European commission. 2003. Joint Research Centre (JRC). Technical Guidance Document on Risk Assessment. https://echa.europa.eu/documents/10162/16960216/tgdpart1_2ed_en.pdf [23 March 2016].
12. European Commission. 2013a. Communication from the Commission to the European Parliament and the Council on the Animal Testing and Marketing Ban and on the State of Play in Relation to Alternative Methods in the Field of Cosmetics. http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/com_at_2013_en.pdf [23 March 2016].
13. European Commission. 2013b. EURL ECVAM progress report on the development, validation and regulatory acceptance of alternative methods (2010–2013). https://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-status-reports/files/eurl-ecvam-report-cosmetics-2013 [23 March 2016].
14. Gerberick GF, Ryan CA, Dearman RJ, Kimber I. 2007a. Local lymph node assay (LLNA) for detection of sensitization capacity of chemicals. Methods 41: 54–60.
15. Gerberick GF, Ryan CA, Kern PS, Dearman RJ, Kimber I, Patlewicz GY, Basketter DA. 2004a. A chemical dataset for evaluation of alternative approaches to skin-sensitization testing. Contact Dermatitis 50: 274–288.
16. Gerberick GF, Ryan CA, Kern PS, Schlatter H, Dearman RJ, Kimber I, Patlewicz GY, Basketter DA. 2005. Compilation of historical local lymph node data for evaluation of skin sensitization alternative methods. Dermatitis 16: 157–202.
17. Gerberick GF, Vassallo JD, Bailey RE, Chaney JG, Morrall SW, Lepoittevin JP. 2004b. Development of a Peptide Reactivity Assay for Screening Contact Allergens. Toxicol. Sci. 81: 332–343.
18. Gerberick GF, Vassallo JD, Foertsch LM, Price BB, Chaney JG, Lepoittevin JP. 2007b. Quantificaton of Chemical Peptide Reactivity for Screening Contact Allergens: A Classification Tree Model Approach. Toxicol. Sci. 97: 417–427.
19. Goodwin LD, Leech NL. 2006. Understanding correlation: factors that affect the size of r. J. Exp. Educ. 74: 251–266.
20. Hoffmann S. 2015. LLNA variability: An essential ingredient for a comprehensive assessment of non-animal skin sensitization test methods and strategies. ALTEX 32: 379–383.
21. ICCVAM. 1999. The Results of an Independent Peer Review Evaluation Coordinated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program Center for the Evaluation of Alternative Toxicological Methods (NICEATM). https://ntp.niehs.nih.gov/iccvam/docs/immunotox_docs/llna/llnarep.pdf [23 March 2016].
22. ICCVAM. 2009. Recommended Performance Standards: Murine Local Lymph Node Assay. NIH Publication Number 09–7357. Research Triangle Park, NC: National Institute of Environmental Health Sciences. https://iccvam.niehs.nih.gov/docs/immunotox_docs/llna-ps/LLNAPerfStds.pdf [23 March 2016].
23. Kimber I, Basketter DA, Berthold K, Butler M, Garrigue J-L, Lea L, Newsome C, Roggeband R, Steiling W, Stroppi G, Waterman S, Wiemann C. 2001. Skin sensitization testing in potency and risk assessment. Toxicol. Sci. 59: 198–208.
24. Kimber I, Hilton J, Dearman RJ, Gerberick GF, Ryan CA, Basketter DA, Scholes EW, Ladics GS, Loveless SE, House RV. 1995. Guy A, An international evaluation of the murine local lymph node assay and comparison of modified procedures. Toxicology 103: 63–73.
25. Landsteiner K, Jacobs J. 1936. Studies on the sensitization of animals with simple chemical compounds II. J. Exp. Med. 64: 625–639.
26. Loveless SE, Ladics GS, Gerberick GF, Ryan CA, Basketter DA, Scholes EW, House RV, Hilton J, Dearman RJ, Kimber I. 1996. Further evaluation of the local lymph node assay in the final phase of an international collaborative trial. Toxicology 108: 141–152.
27. OECD. 2002. OECD Guideline for the Testing of Chemicals Skin Sensitisation: Local Lymph Node Assay. ftp://ftp.cdc.gov/pub/Documents/OEL/06.%20Dotson/References/OECD_2002.pdf [23 March 2016].
28. OECD. 2014. OECD Guideline for the Testing of Chemicals Draft Proposal for a New Test Guideline in Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA). http://www.oecd.org/chemicalsafety/testing/Draft_DPRA_TG_final_15May2014.pdf [23 March 2016].
29. Roberts DW. 2012. Quantifying skin sensitization potency. Contact Dermatitis 66: 356–357.
30. Roberts DW, Aptula AO. 2008. Determinants of skin sensitisation potential. J. Appl. Toxicol. 28: 377–387.
31. Sheskin DJ. 2003. Handbook of Parametric and Nonparametric Statistical Procedures, 3rd edn. Chapman & Hall/CRC: USA.
32. US EPA. 2003. Health Effects Test Guidelines OPPTS 870.2600 Skin Sensitization. https://ntp.niehs.nih.gov/iccvam/suppdocs/feddocs/epa/epa_870r_2600.pdf [23 March 2016].
33. Warbrick EV, Dearman RJ, Basketter DA, Kimber I. 1999. Influence of application vehicle on skin sensitization to methylchloroisothiazolinone/methylisothiazolinone: an analysis using the local lymph node assay. Contact Dermatitis 41: 325–329.