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The 3T3 neutral red uptake phototoxicity test

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The 3T3 neutral red uptake phototoxicity test : practical experience and implications for phototoxicity testing - the report of an ECVAM-EFPIA workshop. / Ceridono, Mara; Tellner, Pär; Bauer, Daniel; Barroso, João ; Alépée, Nathalie; Corvi, Raffaella; De Smedt, Ann; Fellows, Mick D.; Gibbs, Neil K.; Heisler, Eckhard; Jacobs, Abigail; Jirova, Dagmar; Jones, David; Kandárová, Helena; Kasper, Peter; Akunda, Jacqueline Kinyamu; Krul, Cyrille; Learn, Douglas; Liebsch, Manfred; Lynch, Anthony M.; Muster, Wolfgang; Nakamura, Kazuichi; Nash, J. Frank; Pfannenbecker, Uwe; Phillips, Gareth; Robles, Catherine; Rogiers, Vera; Van De Water, Femke; Liminga, Ulla Wändel ; Vohr, Hans-Werner; Wattrelos, Olivier; Woods, Julie; Zuang, Valérie; Kreysa, Joachim; Wilcox, Phil.

In: Regulatory Toxicology and Pharmacology, Vol. 63, No. 3, 2012, p. 480-488.

Research output: Contribution to journalArticle

Harvard

Ceridono, M, Tellner, P, Bauer, D, Barroso, J, Alépée, N, Corvi, R, De Smedt, A, Fellows, MD, Gibbs, NK, Heisler, E, Jacobs, A, Jirova, D, Jones, D, Kandárová, H, Kasper, P, Akunda, JK, Krul, C, Learn, D, Liebsch, M, Lynch, AM, Muster, W, Nakamura, K, Nash, JF, Pfannenbecker, U, Phillips, G, Robles, C, Rogiers, V, Van De Water, F, Liminga, UW, Vohr, H-W, Wattrelos, O, Woods, J, Zuang, V, Kreysa, J & Wilcox, P 2012, 'The 3T3 neutral red uptake phototoxicity test: practical experience and implications for phototoxicity testing - the report of an ECVAM-EFPIA workshop' Regulatory Toxicology and Pharmacology, vol 63, no. 3, pp. 480-488., 10.1016/j.yrtph.2012.06.001

APA

Ceridono, M., Tellner, P., Bauer, D., Barroso, J., Alépée, N., Corvi, R., ... Wilcox, P. (2012). The 3T3 neutral red uptake phototoxicity test: practical experience and implications for phototoxicity testing - the report of an ECVAM-EFPIA workshop. Regulatory Toxicology and Pharmacology, 63(3), 480-488. 10.1016/j.yrtph.2012.06.001

Vancouver

Ceridono M, Tellner P, Bauer D, Barroso J, Alépée N, Corvi R et al. The 3T3 neutral red uptake phototoxicity test: practical experience and implications for phototoxicity testing - the report of an ECVAM-EFPIA workshop. Regulatory Toxicology and Pharmacology. 2012;63(3):480-488. Available from: 10.1016/j.yrtph.2012.06.001

Author

Ceridono, Mara; Tellner, Pär; Bauer, Daniel; Barroso, João ; Alépée, Nathalie; Corvi, Raffaella; De Smedt, Ann; Fellows, Mick D.; Gibbs, Neil K.; Heisler, Eckhard; Jacobs, Abigail; Jirova, Dagmar; Jones, David; Kandárová, Helena; Kasper, Peter; Akunda, Jacqueline Kinyamu; Krul, Cyrille; Learn, Douglas; Liebsch, Manfred; Lynch, Anthony M.; Muster, Wolfgang; Nakamura, Kazuichi; Nash, J. Frank; Pfannenbecker, Uwe; Phillips, Gareth; Robles, Catherine; Rogiers, Vera; Van De Water, Femke; Liminga, Ulla Wändel ; Vohr, Hans-Werner; Wattrelos, Olivier; Woods, Julie; Zuang, Valérie; Kreysa, Joachim; Wilcox, Phil / The 3T3 neutral red uptake phototoxicity test : practical experience and implications for phototoxicity testing - the report of an ECVAM-EFPIA workshop.

In: Regulatory Toxicology and Pharmacology, Vol. 63, No. 3, 2012, p. 480-488.

Research output: Contribution to journalArticle

Bibtex - Download

@article{64f781a90af044a1969601aa99dfdcfc,
title = "The 3T3 neutral red uptake phototoxicity test: practical experience and implications for phototoxicity testing - the report of an ECVAM-EFPIA workshop",
author = "Mara Ceridono and Pär Tellner and Daniel Bauer and João Barroso and Nathalie Alépée and Raffaella Corvi and {De Smedt}, Ann and Fellows, {Mick D.} and Gibbs, {Neil K.} and Eckhard Heisler and Abigail Jacobs and Dagmar Jirova and David Jones and Helena Kandárová and Peter Kasper and Akunda, {Jacqueline Kinyamu} and Cyrille Krul and Douglas Learn and Manfred Liebsch and Lynch, {Anthony M.} and Wolfgang Muster and Kazuichi Nakamura and Nash, {J. Frank} and Uwe Pfannenbecker and Gareth Phillips and Catherine Robles and Vera Rogiers and {Van De Water}, Femke and Liminga, {Ulla Wändel} and Hans-Werner Vohr and Olivier Wattrelos and Julie Woods and Valérie Zuang and Joachim Kreysa and Phil Wilcox",
note = "Copyright 2012 Elsevier B.V., All rights reserved.",
year = "2012",
doi = "10.1016/j.yrtph.2012.06.001",
volume = "63",
pages = "480--488",
journal = "Regulatory Toxicology and Pharmacology",
issn = "0273-2300",
publisher = "Elsevier",
number = "3",

}

RIS (suitable for import to EndNote) - Download

TY - JOUR

T1 - The 3T3 neutral red uptake phototoxicity test

T2 - Regulatory Toxicology and Pharmacology

AU - Ceridono,Mara

AU - Tellner,Pär

AU - Bauer,Daniel

AU - Barroso,João

AU - Alépée,Nathalie

AU - Corvi,Raffaella

AU - De Smedt,Ann

AU - Fellows,Mick D.

AU - Gibbs,Neil K.

AU - Heisler,Eckhard

AU - Jacobs,Abigail

AU - Jirova,Dagmar

AU - Jones,David

AU - Kandárová,Helena

AU - Kasper,Peter

AU - Akunda,Jacqueline Kinyamu

AU - Krul,Cyrille

AU - Learn,Douglas

AU - Liebsch,Manfred

AU - Lynch,Anthony M.

AU - Muster,Wolfgang

AU - Nakamura,Kazuichi

AU - Nash,J. Frank

AU - Pfannenbecker,Uwe

AU - Phillips,Gareth

AU - Robles,Catherine

AU - Rogiers,Vera

AU - Van De Water,Femke

AU - Liminga,Ulla Wändel

AU - Vohr,Hans-Werner

AU - Wattrelos,Olivier

AU - Woods,Julie

AU - Zuang,Valérie

AU - Kreysa,Joachim

AU - Wilcox,Phil

N1 - Copyright 2012 Elsevier B.V., All rights reserved.

PY - 2012

Y1 - 2012

N2 - This is the report from the "ECVAM-EFPIA workshop on 3T3 NRU Phototoxicity Test: Practical Experience and Implications for Phototoxicity Testing", jointly organized by ECVAM and EFPIA and held on the 25-27 October 2010 in Somma Lombardo, Italy. The European Centre for the Validation of Alternative Methods (ECVAM) was established in 1991 within the European Commission Joint Research, based on a Communication from the European Commission (1991). The main objective of ECVAM is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine and replace the use of laboratory animals. The European Federation of Pharmaceuticals Industries and Association (EFPIA) represent the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 40 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2200 companies committed to researching, developing and bringing to patients new medicines that improve health and the quality of life around the world. The workshop, co-chaired by Joachim Kreysa (ECVAM) and Phil Wilcox (GSK, EFPIA) involved thirty-five experts from academia, regulatory authorities and industry, invited to contribute with their experiences in the field of phototoxicology. The main objectives of the workshop were: - to present 'in use' experience of the pharmaceutical industry with the 3T3 Neutral Red Uptake Phototoxicity Test (3T3 NRU-PT), - to discuss why it differs from the results in the original validation exercise, - to discuss technical issues and consider ways to improve the usability of the 3T3 NRU-PT for (non-topical) pharmaceuticals, e.g., by modifying the threshold of chemical light absorption to trigger photo-toxicological testing, and by modifying technical aspects of the assay, or adjusting the criteria used to classify a positive response. During the workshop, the assay methodology was reviewed by comparing the OECD Test Guideline (TG 432) with the protocols used in testing laboratories, data from EFPIA and JPMA 'surveys' were presented and possible reasons for the outcomes were discussed. Experts from cosmetics and pharmaceutical industries reported on their experience with the 3T3 NRU-PT and evidence was presented for phototoxic clinical symptoms that could be linked to certain relevant molecules. Brainstorming sessions discussed if the 3T3 NRU-PT needed to be improved and whether alternatives to the 3T3 NRU-PT exist. Finally, the viewpoint from EU and US regulators was presented. In the final session, the conclusions of the meeting were summarized, with action points. It was concluded that the 3T3 NRU-PT identifies phototoxicological hazards with a 100% sensitivity, and thus is accepted as the tier one test that correctly identifies the absence of phototoxic potential. Consequently, positive results in the 3T3 NRU-PT often do not translate into a clinical phototoxicity risk. Possible ways to improve the practical use of this assay include: (i) adaptation of changed UV/vis-absorption criteria as a means to reduce the number of materials tested, (ii) reduction of the highest concentration to be tested, and (iii) consideration of modifying the threshold criteria for the prediction of a positive call in the test. © 2012 Elsevier Inc.

AB - This is the report from the "ECVAM-EFPIA workshop on 3T3 NRU Phototoxicity Test: Practical Experience and Implications for Phototoxicity Testing", jointly organized by ECVAM and EFPIA and held on the 25-27 October 2010 in Somma Lombardo, Italy. The European Centre for the Validation of Alternative Methods (ECVAM) was established in 1991 within the European Commission Joint Research, based on a Communication from the European Commission (1991). The main objective of ECVAM is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine and replace the use of laboratory animals. The European Federation of Pharmaceuticals Industries and Association (EFPIA) represent the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 40 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2200 companies committed to researching, developing and bringing to patients new medicines that improve health and the quality of life around the world. The workshop, co-chaired by Joachim Kreysa (ECVAM) and Phil Wilcox (GSK, EFPIA) involved thirty-five experts from academia, regulatory authorities and industry, invited to contribute with their experiences in the field of phototoxicology. The main objectives of the workshop were: - to present 'in use' experience of the pharmaceutical industry with the 3T3 Neutral Red Uptake Phototoxicity Test (3T3 NRU-PT), - to discuss why it differs from the results in the original validation exercise, - to discuss technical issues and consider ways to improve the usability of the 3T3 NRU-PT for (non-topical) pharmaceuticals, e.g., by modifying the threshold of chemical light absorption to trigger photo-toxicological testing, and by modifying technical aspects of the assay, or adjusting the criteria used to classify a positive response. During the workshop, the assay methodology was reviewed by comparing the OECD Test Guideline (TG 432) with the protocols used in testing laboratories, data from EFPIA and JPMA 'surveys' were presented and possible reasons for the outcomes were discussed. Experts from cosmetics and pharmaceutical industries reported on their experience with the 3T3 NRU-PT and evidence was presented for phototoxic clinical symptoms that could be linked to certain relevant molecules. Brainstorming sessions discussed if the 3T3 NRU-PT needed to be improved and whether alternatives to the 3T3 NRU-PT exist. Finally, the viewpoint from EU and US regulators was presented. In the final session, the conclusions of the meeting were summarized, with action points. It was concluded that the 3T3 NRU-PT identifies phototoxicological hazards with a 100% sensitivity, and thus is accepted as the tier one test that correctly identifies the absence of phototoxic potential. Consequently, positive results in the 3T3 NRU-PT often do not translate into a clinical phototoxicity risk. Possible ways to improve the practical use of this assay include: (i) adaptation of changed UV/vis-absorption criteria as a means to reduce the number of materials tested, (ii) reduction of the highest concentration to be tested, and (iii) consideration of modifying the threshold criteria for the prediction of a positive call in the test. © 2012 Elsevier Inc.

UR - http://www.scopus.com/inward/record.url?scp=84863006329&partnerID=8YFLogxK

U2 - 10.1016/j.yrtph.2012.06.001

DO - 10.1016/j.yrtph.2012.06.001

M3 - Article

VL - 63

SP - 480

EP - 488

JO - Regulatory Toxicology and Pharmacology

JF - Regulatory Toxicology and Pharmacology

SN - 0273-2300

IS - 3

ER -

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