Development of LLNA:DAE: A new local lymph node assay that includes the elicitation phase, discriminates borderline-positive chemicals, and is useful for cross-sensitization testing

Journal of Toxicological Sciences

Volumn 39, Issue 1, 2014, Pages 147-161

  Yamashita, Kunihiko ^a,c   Shinoda, Shinsuke ^b   Hagiwara, Saori ^b   Itagaki, Hiroshi ^c  

^a DAICEL CORPORATION   (Japan)

^b Drug Safety Testing Center Co   (Japan)

^c YOKOHAMA NATIONAL UNIVERSITY   (Japan)

Author keywords

Cross sensitization; Elicitation; Induction; LLNA; LLNA:DA; LLNA:DAE; Lymph node weight; Sensitization

Indexed keywords

1 CHLORO 2, 4 DINITROBENZENE; 1 FLUORO 2, 4 DINITROBENZENE; 1, 4 BENZOQUINONE; 2 MERCAPTOBENZOTHIAZOLE; 2 PROPANOL; 5 CHLORO 2 METHYL 4 ISOTHIAZOLIN 3 ONE; ADENOSINE TRIPHOSPHATE; BENZOIC ACID; CHLOROBENZENE; CINNAMALDEHYDE DERIVATIVE; CINNAMYL ALCOHOL; CITRAL; COBALT CHLORIDE; DIAZOLIDINYL UREA; DODECYL SULFATE SODIUM; ETHYLENE GLYCOL DIMETHACRYLATE; EUGENOL; HEXANE; HEXYL CINNAMALDEHYDE DERIVATIVE; HYDROQUINONE; IMIDAZOLIDINYL UREA; ISOEUGENOL; LACTIC ACID; METHACRYLIC ACID METHYL ESTER; NICKEL CHLORIDE; PHENYLBENZOIC ACID; PHENYLENEDIAMINE; SALICYLIC ACID; SALICYLIC ACID METHYL ESTER; UNCLASSIFIED DRUG; XYLENE;

ANIMAL TISSUE; ARTICLE; CELL PROLIFERATION; CONTROLLED STUDY; CROSS ALLERGY; FEMALE; LOCAL LYMPH NODE ASSAY; MOUSE; NONHUMAN; ORGAN WEIGHT; SKIN SENSITIZATION;

ANIMALS; BENZOQUINONES; CROSS REACTIONS; DERMATITIS, ALLERGIC CONTACT; DINITROCHLOROBENZENE; DINITROFLUOROBENZENE; EAR; FEMALE; HYDROQUINONES; IRRITANTS; LOCAL LYMPH NODE ASSAY; LYMPH NODES; MICE; MICE, INBRED CBA; SKIN;

EID: 84891894850     PISSN: 03881350     EISSN: 18803989     Source Type: Journal    
DOI: 10.2131/jts.39.147     Document Type: Article

References (42)

1. Ashikaga, T., Yoshida, Y., Hirota, M., Itagaki, H., Miyazawa, M., Ito, Y. and Toyoda, H. (2006): Development of an in vitro skin sensitization test using human cell line activation test (h-CLAT).I. Optimization of the h-CALT protocol. Toxicol. In Vitro, 20, 767-773.
2. Basketter, D.A. and Goodwin, B.F.J. (1988): Investigation of the prohapten concept. Cross reactions between 1,4-substituted benzene derivatives in the guinea pig. Contact Dermatitis, 19, 248-253.
3. Basketter, D.A., Gerberick, G.F., Kimber, I. and Loveless, S.E. (1996): The local lymph node assay: a viable alternative to currently accepted skin sensitization tests. Food Chem. Toxicol., 34, 985-997.
4. Basketter, D.A., Lea, L.J., Cooper, K., Stocks, J., Dickens, A., Pate, I., Dearman, R.J. and Kimber, I. (1999a): Threshold for classification as a skin sensitizer in the Local Lymph Node assay: a statistical evaluation. Food Chem. Toxicol., 37, 1167-1174.
5. Basketter, D.A., Lea, L.J., Cooper, K.J., Ryan, C.A., Gerberick, G. F., Dearman, R.J. and Kimber, I. (1999b): Identification of metal allergens in the Local Lymph Node assay. Am. J. Contact Dermat., 10, 207-212.
6. Basketter, D.A., Ball, N., Cagen, S., Carillo, J.-C., Certa, H., Eigler, D., Carcia, C., Esch, H., Graham, C., Haux, C., Kreiling, R. and Mehling, A. (2009): Application of a weight of evidence approach to assessing discordant sensitisation datasets: Implications for REACH. Regul. Toxicol. Pharmacol., 55, 90-96.
7. Buehler, E.V. (1965): Delayed contact hypersensitivity in the guinea pig. Arch. Dermatol., 91, 171-177.
8. Dean, J.H., Twerdok, L.E., Tice, R.R., Sailstad, D.M., Hattan, D.G. and Stokes, W.S. (2001): ICCVAM evaluation of the murine local lymph node assay: II. Conclusions and recommendations of an independent scientific peer review panel. Regul. Toxicol. Pharmacol., 34, 258-273.
9. Dunn, J.B., George, R.M., Siglin, C.J. and Blaszcak, L.D. (1990): Variability of a Mouse Ear Swelling Test (MEST) in predicting weak and moderate contact sensitization. Fundam. Appl. Toxicol., 15, 242-248.
10. Gad, S.C., Dunn, B.J., Dobbs, D.W., Reilly, C. and Walsh, D. (1986): Development and Validation of an Alternative Dermal Sensitization Test: The Mouse Ear Swelling Test (MEST). Toxicol. Appl. Pharm., 84, 93-114.
11. Gad, S.C. (1994): The mouse ear swelling test (MEST) in the 1990s. Toxicology, 93, 33-46.
12. Gerberick, G.F., Ryan, C.A., Kimber, I., Dearman, R.J., Lea, L.J. and Basketter, D.A. (2000): Local lymph node assay: validation assessment for regulatory purposes. Am. J. Contact Dermatitis, 11, 3-18.
13. Gerberick, G.F., Ryan, C.A., Kern, P.S., Schlatter, H., Dearman, R.J., KImber, I., Patlewicz, G.Y. and Basketter, D.A. (2005): Compilation of historical local lymph node data for evaluation of skin sensitization alternative methods. Dermatitis, l16, 157-202.
14. Garcia-Peres, A. (1978): Occupational dermatitis from DNFB with cross sensitivity to DNCB. Contact Dermatitis, 4, 125-127.
15. Goon, A.T.J., Isaksson, M., Zimerson, E., Goh, C.L. and Bruze, M. (2006): Contact allergy to (meth)acrylates in the dental series in southern Sweden: simultaneous positive patch test reaction patterns and possible screening allergens. Contact Dermatitis, 55, 219-226.
16. Grindon, C., Combes, R., Cronin, T.D.M., Roberts, D.W. and Garrod, F.J. (2008): An integrated decision-tree testing strategy for skin sensitisation with respect to the requirements of the EU REACH legislation. Altern Lab. Anim., 36 (Suppl. 1), 75-89.
17. Haneke, K.E., Tice, R.R., Carson, B.L., Margolin, B.H. and Stokes, W.S. (2001): ICCVAM evaluation of the murine local lymph node assay: III. Data analyses completed by the national toxicology program interagency center for the evaluation of alternative toxicological methods. Regul. Toxicol. Pharmacol., 34, 274-286.
18. Hayes, B.B. and Meade, J.B. (1999): Contact sensitivity to selected acrylate compounds in B6C3F1 mice: relative potency, cross reactivity, and comparison of test methods. Drug Chem. Toxicol., 22, 491-506.
19. ICCVAM (2010): ICCVAM Test Method Evaluation Report on the Murine Local Lymph Node Assay: DA, a Nonradioactive Alternative Test Method to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products. NIH Publication No. 10-7551. Research Triangle Park, NC: National Institute of Environmental Health Sciences.
20. Idehara, K., Yamagishi, G., Yamashita, K. and Ito, M. (2008): Characterization and evaluation of a modified local lymph node assay using ATP content as a non-radio isotopic endpoint. J. Pharmacol. Toxicol. Methods, 58, 1-10.
21. Ideahra, K. (2013): Publication of Japanese Patent Application, Publication number, 2013-072692.
22. Kanamori, S., Kaneko, K., Watari, E. and Kawana, S. (2012): The sensitization phase of allergic contact dermatitis consists of at least 2 steps and its completion play a crucial role in the response to all antigens. Journal of Nihon University Medical Association, 8, 199-206.
23. Kimber, I., Mitchell, J.A. and Griffin, A.C. (1986): Development of a murine local lymph node assay for the determination of sensitizing potential. Food Chem. Toxicol., 24, 585-586.
24. Kimber, I., Hilton, J. and Weisenberger, C. (1989): The murine local lymph node assay for identification of contact allergens: a preliminary evaluation of in situ measurement of lymphocyte proliferation. Contact Dermatitis, 21, 215-220.
25. Kimber, I., Hilton, J., Dearman, R.J., Gerberick, G.F., Ryan, C.A., Basketter, D.A., Lea, L.J., House, R.V., Ladics, G.S., Loveless, S.E. and Hastings, K.L. (1998): Assessment of the skin sensitization potential of topical medicaments using the local lymph node assay: an interlaboratory evaluation. J. Toxicol. Environ. Health, Part A, 53, 563-579,
26. Magunusson, B. and Kligman, A.M. (1969): The identification of contact allergens by animal assay. The guinea pig maximization test. J. Invest. Dermatol., 52, 268-276.
27. Nakamura, A., Momma, J., Sekiguchi, H., Noda, T., Yamano, T., Kaniwa, M., Kojima, S., Tsuda, M. and Kurokawa, Y. (1994): A new protocol and criteria for quantitative determination of sensitization potencies of chemicals by guinea pig maximization test. Contact Dermatitis, 31, 72-85.
28. OECD (1992): OECD guideline for the Testing of Chemicals, Test No.406.: Skin sensitization, adopted July 1992. Paris, France: Organization for Economic Cooperation and Development.
29. OECD (2002): OECD guideline for the Testing of Chemicals, Test No.429.: Skin sensitization: Local Lymph Node Assay, adopted July 2002. Paris, France: Organization for Economic Cooperation and Development.
30. OECD (2010a): OECD guideline for the Testing of Chemicals, Test No.442A.: Skin sensitization: Local Lymph Node Assay:DA, adopted July 2010. Paris, France: Organization for Economic Cooperation and Development.
31. OECD (2010b): OECD guideline for the Testing of Chemicals, Test No.429.: Skin sensitization: Local Lymph Node Assay, adopted July 2010. Paris, France: Organization for Economic Cooperation and Development.
32. OECD (2010c): OECD guideline for the Testing of Chemicals, Test No.429.: Skin sensitization: Local Lymph Node Assay BrdUELISA, adopted July 2010. Paris, France: Organization for Economic Cooperation and Development.
33. Omori, T., Idehara, K., Kojima, H., Sozu, T., Arima, K., Goto, H., Hanada, T., Ikarashi, Y., Inoda, T., Kanazawa, Y., Kosaka, T., Maki, E., Morimoto, T., Shinoda, S., Shinoda, N., Takeyoshi, M., Tanaka, M., Uratani, M., Usami, M., Yamanaka, A., Yoneda, T., Yoshimura, I. and Yuasa, A. (2008): Interlaboratory validation of the modified murine local lymph node assay based on adenosine triphosphate measurement. J. Pharmacol. Toxicol. Methods, 58, 11-26.
34. Sakaguchi, H.S., Ryan, C.A., Ovigne, J.-M., Schroeder, K.R. and Ashikaga, T. (2010): Predicting skin sensitization potential and inter-laboratory reproducibility of a human Cell Line Activation Test (h-CLAT) in the European Cosmetics Association (COLIPA) ring trials. Toxicology, 24, 1810-1820.
35. Sailstad, D.M., Hattan, D., Hill, R.N. and Stokes, W.S. (2001): ICCVAM evaluation of the murine local lymph node assay. I. The ICCVAM review process. Regul. Toxicol. Pharmacol., 34, 249-257.
36. Takenouchi, O., Miyazawa, M., Saito, K., Ashikaga, T. and Sakaguchi, H., (2013): Predictive performance of the human Cell Line Activation Test (h-CLAT) for lipophilic chemicals with high octanol-water partition coefficients. J. Toxicol. Sci., 38, 599-609.
37. Takeyoshi, M., Yamasaki, K., Yakabe, Y., Takatsuki, M. and Kimber, I. (2001): Development of non-radio isotopic endpoint of murine local lymph node assay based on 5-bromo-2'-deoxyuridine (BrdU) incorporation. Toxicol. Lett., 119, 203-208.
38. Takeyoshi, M., Sawaki, M., Yamasaki, K. and Kimber, I. (2003): Assessment of statistic analysis in non-radioisotopic local lymph node assay (non-RI-LLNA) with α-hexylcinnamic aldehyde as an example. Toxicology, 191, 259-263.
39. Tse, H.Y., Ronald A, Schwartz, H. and Paul, W.E. (1980): Cell-Cell interactions in the T Cell proliferative response, I. Analysis of the Cell types involved and evidence for nonspecific T Cell recruitment. J. Immunol., 125, 491-500.
40. Woolhiser, M. R., Munson, A. E. and Meade, B. J. (2000): Comparison of mouse strains using the local lymph node assay. Toxicology, 146, 221-227.
41. Yamashita, K., Idehara, K., Fukuda, N., Yamagishi, G. and Kawada, N. (2005): Development of a modified local lymph node assay using ATP measurement as an endpoint. AATEX, 11, 136-144.
42. Yamashita, K., Shinoda, S. and Hagiwara, S. (2013): Development of new LLNA:DA that incorporated the elicitation phase. J. Toxicol. Sci., 38(Suppl), S327.