Library

Challenges faced in developing inhalation Thresholds of Toxicological Concern (TTC).

Submitted to Regulatory Toxicology and Pharmacology. Bowden A, Escher S, Rose J, Sadekar N, Patlewicz G, O’Keeffe L, Bury D, Hewitt NJ, Giusti A, Rothe H,

From Worst-Case to Reality – Case Studies Illustrating Tiered Refinement of Consumer Exposure to Cosmetic Ingredients.

Submitted to Regulatory Toxicology and Pharmacology. Tozer S, Alexander-White C, Amin R, Audebert F, Barratt C, O` Brien J, Bury D, Dika Nguea H, Dimopoulou M, Farahmand S, Fritz S, Gerber E, Giusti A, Goodwin W, Kirsch T, Oreffo V.

The Role of a Molecular Informatics Platform to Support Next Generation Risk Assessment.

Submitted for publication. Chihae Yang, James F Rathman, Bruno Bienfait, Matthew Burbank, Ann Detroyer, Steven J. Enoch, James W. Firman, Steve Gutsell, Nicola J. Hewitt,  Bryan Hobocienski, Gerry Kenna, Judith C. Madden, Tomasz Magdziarz, Jörg Marusczyk, AleksandraMostrag-Szlichtyng, Christopher-Tilman Krueger, Cathy Lester, Catherine Mahoney, Abdulkarim Najjar, Gladys Ouedraogo, Katarzyna R. Przybylak, J. Vinicius Ribeiro, Mark T.D. Cronin.

Applying a Next Generation Risk Assessment (NGRA) framework for Skin Sensitisation to inconsistent New Approach Methodology (NAM) information.

Gilmour N, Alépée N, Hoffmann S, Kern PS, van Vliet E, Bury D, Miyazawa M, Nishida H, and Cosmetics Europe ALTEX, 2022, under revision.  

Development of a microphysiological skin-liver-thyroid Chip3 and its application to evaluate the effects on thyroid hormones of topically applied cosmetic ingredients under consumer-relevant conditions

Tao T-P, Maschmeyer I, LeCluyse EL, Rogers E, Brandmair K, Gerlach S, Przibilla J, Kern F, Genies C; Jaques C, Najjar A, Schepky A, Marx U, Kühnl J, Hewitt NJ Frontiers in Pharmacology, section Predictive Toxicology.

Application of a Next Generation Risk Assessment (NGRA) framework for skin sensitisation: a case study for Diethanolamine.

Nathalie Alépée, Dagmar Bury, Nicola Gilmour, Sebastian Hoffmann, Petra S. Kern, Masaaki Miyazawa, Hayato Nishida, Erwin van Vliet. Accepted by OECD and to be published in 2023.

Practical application of the interim internal threshold of toxicological concern (iTTC): a case study based on clinical data

Najjar A, Ellison CA, Gregoire S, Hewitt NJ. Arch Toxicol. 2023 Jan;97(1):155-164. doi: 10.1007/s00204-022-03371-6. Epub 2022 Sep 23.

Case Study on the Use of Integrated Approaches for Testing and Assessment for skin sensitisation: Demonstrating the Next Generation Risk Assessment Framework using Geraniol. OECD Series on Testing and Assessment No. 368,

Nathalie Alépée, Fanny Boisleve, Dagmar Bury, Nicola Gilmour, Sebastian Hoffmann, Petra Kern, Jochen Kühnl, Masaaki Miyazawa, Hayato Nishida, Erwin Van Vliet, Mustafa Varçin

Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens.

Ouedraogo G, Alexander-White C, Bury D, Clewell HJ 3rd, Cronin M, Cull T, Dent M, Desprez B, Detroyer A, Ellison C, Giammanco S, Hack E, Hewitt NJ, Kenna G, Klaric M, Kreiling R, Lester C, Mahony C, Mombelli E, Naciff J, O'Brien J, Schepky A, Tozer S, van der Burg B, van Vugt-Lussenburg B, Stuard S, Cosmetics Europe Regul Toxicol Pharmacol.

Expansion of the Cosmetics Europe skin sensitisation database with new substances and PPRA data.

Hoffmann S, Alépée N, Gilmour N, Kern PS, van Vliet E, Boislève F, Bury D, Cloudet E, Klaric M, Kühnl J, Lalko JF, Mewes K, Miyazawa M, Nishida H, Tam Brami MT, Varçin M, Api AM, Europe C Regul Toxicol Pharmacol. 2022 Jun;131:105169. doi: 10.1016/j.yrtph.2022.105169. Epub 2022 Apr 18.

Applying a Next Generation Risk Assessment (NGRA) framework for Skin Sensitisation to inconsistent New Approach Methodology (NAM) information

Gilmour N, Alépée N, Hoffmann S, Kern PS, van Vliet E, Bury D, Miyazawa M, Nishida H, and Cosmetics Europe. ALTEX, 2022, under revision.

A 10-step framework for use of read-across (RAX) in next generation risk assessment (NGRA) for cosmetics safety assessment. Regulatory Toxicology and Pharmacology

Camilla Alexander-White, Dagmar Bury, Mark Cronin, Matthew Dent, Eric Hack, Nicola J. Hewitt, Gerry Kenna, Jorge Naciff, Gladys Ouedraogo, Andreas Schepky, Catherine Mahony.

Use of in vitro metabolism and biokinetics assays to refine predicted in vivo and in vitro internal exposure to the cosmetic ingredient, phenoxyethanol, for use in risk assessment.

Hewitt NJ, Troutman J, Przibilla J, Schepky A, Ouédraogo G, Mahony C, Kenna G, Varçin M, Dent M, 2022 Jun;131:105132. doi: 10.1016/j.yrtph.2022.105132. Epub 2022 Feb 22. PMID: 35217105.

Chapter 4 – Physiologically based pharmacokinetic modeling software, Editor(s): Jeffrey W. Fisher, Jeffery M. Gearhart, Zhoumeng Lin, Physiologically Based Pharmacokinetic (PBPK) Modeling.

Hack CE, Efremenko AY, Pendse SN, Ellison CA, Najjar A, Hewitt N, Schepky A, Clewell HJ Academic Press, 2020, Pages 81-126, ISBN 9780128185964, https://doi.org/10.1016/B978-0-12-818596-4.00004-7.

Case Study on use of an Integrated Approach for Testing and Assessment (IATA) for Systemic Toxicity of Phenoxyethanol when included at 1% in a body lotion

Samuel J. Bellfield , Harvey J. Clewell, Stella Cochrane, Mark T.D. Cronin, Matthew P. Dent, Bertrand Desprez, Alina Efremenko, James Firman, Joan Fisher, C. Eric Hack, Nicola J. Hewitt, Jade Houghton, Richard Judson , Gerry Kenna, Martina Klaric, Predrag Kukic, Catherine Mahony, Sophie Malcomber, Malgorzata Nepelska, Yuuko Nukada, Beate Nicol, Przemyslaw Piechota, Katarzyna Przybylak, Alexandra Rolaki, Andreas Schepky, Takahiro Suzuki, John A. Troutman, Sarah A. Tozer, Mustafa Varçin, Evita Vandenbossche, Andrew White. This case study was developed by Cosmetics Europe (BIAC) for illustrating practical use of IATA and published as part of  the 2020 review cycle of the IATA Case Studies Project

Performance Statistics of Defined Approaches for Eye Hazard Identification of Non-Surfactant Liquids to Distinguish Between the Three United Nations Globally Harmonized System Categories

Nathalie Alépée, Takayuki Abo, Els Adriaens, Dan Bagley, Karsten R. Mewes, and on behalf of Cosmetics Europe

Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients

M P Dent, E Vaillancourt, R S Thomas, P L Carmichael, G Ouedraogo, H Kojima, J Barroso, J Ansell, T S Barton-Maclaren, S H Bennekou, K Boekelheide, J Ezendam, J Field, S Fitzpatrick, M Hatao, R Kreiling, M Lorencini, C Mahony, B Montemayor, R Mazaro-Costa, J Oliveira, V Rogiers, D Smegal, R Taalman, Y Tokura, R Verma, C Willett, C Yang

Cosmetics Europe evaluation of 6 in silico skin penetration models

Grégoire S, Sorrell I, Lange D, Najjar A, Schepky A, Ellison CA, Troutman J, Fabian E, Duplan H, Genies C, Jacques-Jamin C, Klaric M, Hewitt NJ. Computational Toxicology, Volume 19, August 2021, 100177

Validation of the 3D reconstructed human skin Comet assay, an animal-free alternative for following-up positive results from standard in vitro genotoxicity assays. Mutagenesis

Pfuhler S, Pirow R, Downs TR, Haase A, Hewitt N, Luch A, Merkel M, Petrick C, Said A, Schäfer-Korting M, Reisinger K.

New framework for a non-animal approach adequately assures the safety of cosmetic ingredients – A case study on caffeine.

Bury D, Alexander-White C, Clewell HJ 3rd, Cronin M, Desprez B, Detroyer A, Efremenko A, Firman J, Hack E, Hewitt NJ, Kenna G, Klaric M, Lester C, Mahony C, Ouedraogo G, Paini A, Schepky A; Cosmetics Europe Regul Toxicol Pharmacol.

Effective exposure of chemicals in in vitro cell systems: A review of chemical distribution models

Proença S, Escher BI, Fischer FC, Fisher C, Grégoire S, Hewitt NJ, Nicol B, Paini A, Kramer NI. Toxicol In Vitro. 2021 Mar 1:105133. doi: 10.1016/j.tiv.2021.105133. Epub ahead of print. PMID: 33662518.

Partition coefficient and diffusion coefficient determinations of 50 compounds in human intact skin, isolated skin layers and isolated stratum corneum lipids.

Ellison CA, Tankersley KO, Obringer CM, Carr GJ, Manwaring J, Rothe H, Duplan H, Géniès C, Grégoire S, Hewitt NJ, Jamin CJ, Klaric M, Lange D, Rolaki A, Schepky A. Toxicol In Vitro. 2020 Dec;69:104990. doi: 10.1016/j.tiv.2020.104990. Epub 2020 Sep 1. Erratum in: Toxicol In Vitro. 2021 Mar;71:105050. PMID: 32882340.

The hen’s egg test for micronucleus induction (HET-MN): validation data set, Mutagenesis

Kerstin Reisinger, Dagmar Fieblinger, Andreas Heppenheimer, Jürgen Kreutz, Manfred Liebsch, Andreas Luch, Katrin Maul, Albrecht Poth, Pamela Strauch, Eva Dony, Markus Schulz, Thorsten Wolf, Ralph Pirow,

Validation of the 3D reconstructed human skin micronucleus (RSMN) assay: an animal-free alternative for following-up positive results from standard in vitro genotoxicity assays. Mutagenesis

Pfuhler S, Downs TR, Hewitt NJ, et al.

Demonstration of the first-pass metabolism in the skin of the hair dye, 4-amino-2-hydroxytoluene, using the Chip2 skin-liver microphysiological model.

Tao TP, Brandmair K, Gerlach S, Przibilla J, Géniès C, Jacques-Jamin C, Schepky A, Marx U, Hewitt NJ, Maschmeyer I, Kühnl J J Appl Toxicol

Overall performance of Bovine Corneal Opacity and Permeability (BCOP) Laser Light-Based Opacitometer (LLBO) test method with regard to solid and liquid chemicals testing.

Adriaens, E., Verstraelen, S., Desprez, B., Alépée, N., Abo, T., Bagley, D., Hibatallah, J., Mewes, K. R., Pfannenbecker, U., & Van Rompay, A. R. (2021). Toxicology in vitro : an international journal published in association with BIBRA, 70, 105044.

Internal Threshold of Toxicological Concern (iTTC): Where We Are Today and What Is Possible in the Near Future

Ellison C. A., Api A. M., Becker R. A., Efremenko A. Y., Gadhia S., Hack C. E., Hewitt N. J., Varcin M., Schepky A. (2021).

Metabolism and plasma protein binding of 16 straight- and branched-chain parabens in in vitro liver and skin models.

Lester C, Hewitt NJ, Müller-Vieira U, Mayer M, Ellison C, Duplan H, Genies C, Jacques-Jamin C, Fabian E, Sorrell I, Lange D, Schepky A, Grégoire S Toxicology in Vitro, 2020, 105051, ISSN 0887-2333,

Development of a next generation risk assessment framework for the evaluation of skin sensitisation of cosmetic ingredients

Nicola Gilmour, Petra S Kern, Nathalie Alépée, Fanny Boislève, Dagmar Bury, Elodie Clouet, Morihiko Hirota, Sebastian Hoffmann, Jochen Kühnl, Jon F Lalko, Karsten Mewes, Masaaki Miyazawa, Hayato Nishida, Anne Osmani, Dirk Petersohn, Shuichi Sekine, Erwin van Vliet, Martina Klaric. Regul Toxicol Pharmacol. 2020 Oct;116:104721. doi: 10.1016/j.yrtph.2020.104721.

OECD Publications On Testing And Assessment No. 320: Case Study on use of an Integrated Approach to Testing and Assessment (IATA) and New Approach Methods to Inform a Theoretical Read-Across for Dermal Exposure to Propylparaben from Cosmetics

OECD Publications On Testing And Assessment No. 321: Case Study on the use of Integrated Approaches for Testing and Assessment for Systemic Toxicity Arising from Cosmetic Exposure to Caffeine

Characterization of application scenario-dependent pharmacokinetics and pharmacokinetic properties of permethrin and hyperforin in a dynamic skin and liver multi-organ-chip model

Kühnl J, Tao TP, Brandmair K, Gerlach S, Rings T, Müller-Vieira U, Przibilla J, Genies C, Jaques-Jamin C, Schepky A, Marx U, Hewitt NJ, Maschmeyer I. Toxicology, 2020, 152637, ISSN 0300-483X,

Use of human liver and EpiSkin™ S9 subcellular fractions as a screening assay to compare the in vitro hepatic and dermal metabolism of 47 cosmetics relevant chemicals.

Eilstein J, Grégoire S, Fabre A, Arbey E, Géniès C, Duplan H, Rothe H, Ellison C, Cubberley R, Schepky A, Lange D, Klaric M, Hewitt NJ, Jacques-Jamin C. J Appl Toxicol. 2020 Mar;40(3):416-433. doi: 10.1002/jat.3914. Epub 2020 Jan 8.

Measurement of the Penetration of 56 Cosmetic Relevant Chemicals Into and Through Human Skin Using a Standardized Protocol

Hewitt NJ, Grégoire S, Cubberley R, Duplan H, Eilstein J, Ellison C, Lester C, Fabian E, Fernandez J, Géniès C, Jacques-Jamin C, Klaric M, Rothe H, Sorrell I, Lange D, Schepky A J Appl Toxicol. 2020 Mar;40(3):403-415. doi: 10.1002/jat.3913. Epub 2019 Dec 22.

Finding synergies for the 3Rs – Repeated Dose Toxicity testing: Report from an EPAA Partners’ Forum

Charles Laroche a.b; Erwin Annys.c; Hans Bender.d; Danielle Botelho.e; Phil Botham.f; Susanne Brendler-Schwaab.g; Rick Clayton.h; Marco Corvaro.i; Gianni Dal Negro.j; Frédérique Delannois.j; Matt Dent.k; Christian Desaintes.l; Bertrand Desprez.m; Stephane Dhalluin.n; Andreas Hartmann.o; Simone Hoffmann-Doerr.p; Bruno Hubesch.q; Amaia Irizar.a; Mark T.D.Cronin.a.a;

Use of a simple in vitro test to assess loss of chemical due to volatility during an in vitro human skin absorption study

Grégoire S.a · Cubberley R.b · Duplan H.c · Eilstein J.a · Hewitt N.J.e · Jacques-Jamin C.c · Genies C.c · Klaric M.e · Rothe H.f · Ellison C.g · Fernandez J.h · Schepky A.d Published: 2019; Skin Pharmacol Physiol. 2019 Mar 19;32(3):117-124

A mode-of-action ontology model for safety evaluation of chemicals: Outcome of a series of workshops on repeated dose toxicity

B. Desprez, B. Birk, B. Blaauboer, A. Boobis, P. Carmichael, M. T.D. Cronin, R. Curie, G.Daston, B. Hubesch, P. Jennings, M. Klaric, D. Kroese, C. Mahony, G. Ouédraogo, A. Piersma, A.-N. Richarz, M. Schwarz, J. van Benthem, B. van de Water, M. Vinken , Toxicology in Vitro 59 (2019) 44–50

Development of a defined approach for eye irritation or serious eye damage for liquids, neat and in dilution, based on cosmetics Europe analysis of in vitro STE and BCO

N. Alépée, E. Adriaens, T. Abo, D. Bagley, B. Desprez, J. Hibatallah, K. Mewes, U. Pfannenbecker, À. Sala, A.R. Van Rompay, S. Verstraelen, P. McNamee Toxicology in Vitro 57 (2019) 154–163

Development of a defined approach for eye irritation or serious eye damage for neat liquids based on cosmetics Europe analysis of in vitroRhCE and BCOP test methods

N. Alépée, E. Adriaens, T. Abo, D. Bagley, B. Desprez, J. Hibatallah, K. Mewes, U. Pfannenbecker, À. Sala, A.R. Van Rompay, S. Verstraelen, P. McNamee Toxicology in Vitro 59 (2019) 100–114

Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology – Evolution versus revolution

T.Burgdorfa; A.H.Piersmabc; R.Landsiedeld, R.Clewelle; N.Kleinstreuerf; M.Oelgeschlägera; B.Desprezg; A.Kienhuisb; P.Bosh; R.de Vriesi; L.de With; T.Seidlej; J.Scheelk; G.Schönfelderan; J.van Benthemb; A.M.Vinggaardl; C.Eskesm; J.Ezendamb Toxicology in Vitro 59 (2019) 100–114

Challenges in working towards an internal threshold of toxicological concern (iTTC) for use in the safety assessment of cosmetics: Discussions from the Cosmetics Europe iTTC Working Group workshop

Corie A. Ellison, Karen L. Blackburn, Paul L. Carmichael, Harvey J. Clewell III., Mark T. D. Cronin,  Bertrand Desprez, Sylvia E. Escher, Steve S. Ferguson,  Sébastien Grégoire, Nicola J. Hewitt, Heli M.  Hollnagel, Martina Klaric, Atish Patel, Sabrina Salhi, Andreas Schepky, Barbara G. Schmitt, John F. Wambaugh, Andrew Worth  

Comparison of the metabolism of 10 cosmetics relevant chemicals in EpiSkin™ S9 subcellular fractions and in vitro human skin explants

J Appl Toxicol. 2019 Feb;39(2):385-397. doi: 10.1002/jat.3730. Epub 2018 Oct 21.

A strategy for systemic toxicity assessment based on non-animal approaches: The Cosmetics Europe Long Range Science Strategy programme

2018 Bertrand Desprez, Matt Dent, Detlef Keller, Martina Klaric, Gladys Ouédraogo, RichardCubberley, Hélène Duplan, Joan Eilstein, Corie Ellison, Sébastien Grégoire, Nicola J.Hewitt, Carine Jacques-Jamin, Daniela Lange, Amy Roe, Helga Rothe, Bas J.Blaauboer, Andreas Schepky, Catherine Mahony Toxicol In Vitro. 2018 Aug;50:137-146.

State-of-the-art and new options to assess T cell activation by skin sensitizers: Cosmetics Europe Workshop

2018 Erwin van Vliet, Jochen Kühnl, Carsten Goebel, Silvia Martinozzi-Teissier, Nathalie Alépée, Takao Ashikaga, Brunhilde Blömeke, Aurélia Del Bufalo, Magalie Cluzel, Emanuela Corsini, Nathalie Delrue, Bertrand Desprez, Nichola Gellatly, Christoph Giese, Laura Gribaldo, Sebastian Hoffmann, Martina Klaric, Bernard Maillere, Dean Naisbitt, Marc Pallardy, Marc Vocanson, Dirk Petersohn ALTEX. 2017 Oct 2;35(2):179-192.

Non-animal methods to predict skin sensitization (I): the Cosmetics Europe database

2018 Sebastian Hoffmann, Nicole Kleinstreuer, Nathalie Alépée, David Allen, Anne Marie Api,Takao Ashikaga, Elodie Clouet, Magalie Cluzel, Bertrand Desprez, Nichola Gellatly, Carsten Goebel, Petra S. Kern, Martina Klaric, Jochen Kühnl, Jon F. Lalko, Silvia Martinozzi-Teissier, Karsten Mewes, Masaaki Miyazawa, Rahul Parakhia, Erwin van Vliet, Qingda Zang & Dirk Petersohn Crit Rev Toxicol. 2018 May;48(5):344-358.

Non-animal methods to predict skin sensitization (II): an assessment of defined approaches

2018 Nicole C. Kleinstreuer, Sebastian Hoffmann, Nathalie Alépée, David Allen, Takao Ashikaga, Warren Casey, Elodie Clouet, Magalie Cluzel, Bertrand Desprez, Nichola Gellatly, Carsten Göbel, Petra S. Kern, Martina Klaric, Jochen Kühnl, Silvia Martinozzi-Teissier, Karsten Mewes, Masaaki Miyazawa, Judy Strickland, Erwin van Vliet, Qingda Zang & Dirk Petersohn Crit Rev Toxicol. 2018 May;48(5):359-374.

Workshop on acceleration of the validation and regulatory acceptance of alternative methods and implementation of testing strategies

A.H. Piersma, T. Burgdorf, K. Louekari, B. Desprez, R. Taalman, R. Landsiedel, J. Barroso, V. Rogiers, C. Eskes, M. Oelgeschläger, M. Whelan, A. Braeuning, A.M. Vinggaard, A. Kienhuis, J. van Benthem, J. Ezendam Toxicology in Vitro 50 (2018) 62–74

Validation of the 3D Skin Comet assay using full thickness skin models: Transferability and reproducibility

Reisinger K, Blatz V, Brinkmann J, Downs TR, Fischer A, Henkler F, Hoffmann S, Krul C, Liebsch M, Luch A, Pirow R, Reus AA, Schulz M, Pfuhler S.; Mutat Res. 2018 Mar;827:27-41

Solvent Solubility Testing of Cosmetics-Relevant Chemicals: Methodology and Correlation of Water Solubility to In Silico Predictions

2017 S. Grégoire, R. Cubberley, H. Duplan, J. Eilstein, D. Lange, N. Hewitt, C. Jacques-Jamin, M. Klaric, H. Rothe, C. Ellison, O. Vaillant, A. Schepky J Solution Chem. 2017 Jul;46(7):1349-1363

Comparison of the Skin Penetration of 3 Metabolically Stable Chemicals Using Fresh and Frozen Human Skin

2017 Jacques-Jamin C., Duplan H., Rothe H., Vaillant O., Eilstein J., Grégoire S., Cubberley R., Lange D., Ellison C., Klaric M., Hewitt N., Schepky A. Skin Pharmacol Physiol. 2017;30(5):234-245.

Comparison of protocols measuring diffusion and partition coefficients in the stratum corneum

2017 H. Rothe, C. Obringer, J. Manwaring, C. Avci, W. Wargniez, J. Eilstein, N. Hewitt, R. Cubberley, H. Duplan, D. Lange, C. Jacques‐Jamin, M. Klaric, A. Schepky, S. Grégoire J Appl Toxicol. 2017 Jul;37(7):806-816.

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).

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. (2017) Archives of toxicology, 91(2), 521–547.

Comparison of protocols for measuring cosmetic ingredient distribution in human and pig skin

2016 D. Gerstela, C. Jacques-Jamin, A. Schepky, R. Cubberley, J. Eilstein, S. Grégoire, N. Hewitt, M. Klaric, H. Rothe, H. Duplan Toxicol In Vitro. 2016 Aug;34:153-60.

The Cosmetics Europe strategy for animal-free genotoxicity testing: project status up-date

2014 Pfuhler S., Fautz R., Ouedraogo G., Latil A., Kenny J., Moore C. , Toxicol In Vitro 28(1):18-23.  

Reduction of misleading (“false”) positive results in mammalian cell genotoxicity assays. III: Sensitivity of human cell types to known genotoxic agents

2014 Fowler P., Smith R., Smith K., Young J., Jeffrey L., Carmichael P., Kirkland D., Pfuhler S., Mutat Res pii: S1383- 5718(14)00053-9. doi: 10.1016/j.mrgentox.2014.03.001.  

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

2014 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. , Archives of Toxicology 88, 701-723  

Systematic evaluation of non-animal test methods for skin sensitisation safety assessment (submitted/ review in progress)

2014 Reisinger K. and Hoffmann S., Alepee N., Ashikaga T., Barroso J. Elcombe C., Gellatly N., Galbiati V., Gibbs S., Groux H., Hibatallah J., KellerD., Kern P., Klaric M, Kolle S., Kuehnl J., Lambrechts N., Lindstedt M., Millet M., Martinozzi-Teissier S., Natsch A., Petersohn D., Pike I., Sakaguchi H., Schepky A., Tailhardat M., Templier M., van Vliet E., Maxwell G.,

Use of human in vitro skin models for accurate and ethical risk assessment: metabolic considerations

2013 Hewitt NJ, Edwards RJ, Fritsche E, Goebel C, Aeby P, Scheel J, et al. ,  Toxicol Sci 133(2):209-17.  

Comet assay in reconstructed 3D human epidermal skin models–investigation of intra- and inter-laboratory reproducibility with coded chemicals

2013 Reus AA., Reisinger K., Downs TR., Carr GJ., Zeller A., Corvi R., Krul CA., Pfuhler S. , Mutagenesis 28(6):709-20.  

Evaluation of chemicals requiring metabolic activation in the EpiDerm™ 3D human reconstructed skin micronucleus (RSMN) assay

2013 Aardema MJ., Barnett BB., Mun GC., Dahl EL., Curren RD., Hewitt NJ., Pfuhler S., Mutat Res 750(1-2):40-9.  

Cosmetics Europe multi-laboratory pre-validation of the SkinEthic™ reconstituted human corneal epithelium test method for the prediction of eye irritation

2013 Alépée N., Bessou-Touya S., Cotovio J., De Smedt A., De Wever B., Faller C., Jones P., LeVarlet B., Marrec-Fairley M., Pfannenbecker U., Tailhardat M., van Goethem F., McNamee P. , Toxicology In Vitro. 27, 619-626  

Cosmetics Europe multi-laboratory pre- validation of the EpiOcular™ reconstituted human tissue test method for the prediction of eye irritation

2013 Pfannenbecker U., Bessou-Touya S., Faller C., Harbell J., Jacob T., Raabe H., Tailhardat M., Alépée N., De Smedt A., De Wever B., Jones P., Kaluzhny Y., Le Varlet B., McNamee P., Marrec-Fairley M., Van Goethem F.  Toxicology In Vitro. 27, 619-626  

Skin sensitisation–moving forward with non-animal testing strategies for regulatory purposes in the EU Regulation

2013 Basketter D, Alépée N, Casati S, Crozier J, Eigler D, Griem P, Hubesch B, de Knecht J, Landsiedel R, Louekari K, Manou I, Maxwell G, Mehling A, Netzeva T, Petry T, Rossi LH Toxicol Pharmacol. 67:531-5

Elucidation of xenobiotic metabolism pathways in human skin and human skin models by proteomic profiling

2012 van Eijl S, Zhu Z, Cupitt J, Gierula M, Götz C, Fritsche E, Edwards RJ. ,  PLoS One 7(7):e41721.  

Xenobiotic metabolism capacities of human skin in comparison with a 3D-epidermis model and keratinocyte-based cell culture as in vitro alternatives for chemical testing: phase II enzymes

2012 Götz C, Pfeiffer R, Tigges J, Ruwiedel K, Hübenthal U, Merk HF, et al.  Exp Dermatol 21(5):364-9.  

Xenobiotic metabolism capacities of human skin in comparison with a 3D epidermis model and keratinocyte-based cell culture as in vitro alternatives for chemical testing: activating enzymes (Phase I)

2012 Götz C, Pfeiffer R, Tigges J, Blatz V, Jäckh C, Freytag EM, et al.  Exp Dermatol 21(5):358-63.  

Guiding principles for the implementation of non-animal safety assessment approaches for cosmetics: skin sensitisation

2012 Goebel C., et al.,Regul Toxicol Pharmacol. 2012 Jun;63(1):40-52. doi: 10.1016/j.yrtph.2012.02.007. Epub 2012 Feb 21.  

Effects of the genotoxic compounds, benzo[a]pyrene and cyclophosphamide on phase 1 and 2 activities in EpiDerm™ model

2012 Götz C., Hewitt NJ., Jermann E., Tigges J., Kohne Z., Hübenthal U. , Xenobiotica 42(6):526-37.  

Reduction of misleading (“false”) positive results in mammalian cell genotoxicity assays. II. Importance of accurate toxicity measurement

2012 Fowler P., Smith R., Smith K., Young J., Jeffrey L., Kirkland D., Pfuhler S., Carmichael P. ,  Mutat Res 747(1):104-17.  

Skin exposure to deodorants/antiperspirants in aerosol form

2012 W. Steiling, P. Buttgereit, B. Hall, L. O’Keeffe , B. Safford, S. Tozer, M. Coroama,Food and Chemical Toxicology  

Guiding Principles for the Implementation of Non-animal Safety Assessment Approaches for Cosmetics: Skin Sensitisation

2012 Goebel C, Aeby P, Ade N, Alépée N, Aptula A, Araki D, Dufour E, Gilmour N, Hibatallah J, Keller D, Kern P, Kirst A, Marrec-Fairley M, Maxwell G, Rowland J, Safford B, Schellauf F, Schepky A, Seaman C, Teichert T, Tessier N, Teissier S, Weltzien H. U., Winkler P, Scheel J. Reg Toxicol Pharmacol 63:40-52.

Reduction of misleading (“false”) positive results in mammalian cell genotoxicity assays. I. Choice of cell type

2011 Fowler P., Smith K., Young J., Jeffrey L., Kirkland D., Pfuhler S., Carmichael P., Mutat Res 742(1-2):11-25.  

The reconstructed skin micronucleus assay (RSMN) in EpiDerm: detailed protocol and harmonized scoring atlas

2011 Dahl E.L, Curren R., Barnett BC., Khambatta Z., Reisinger K., Ouedraogo G. ,Mutat Res 720:42-52.  

Update on the Colipa research programme for development of in vitro alternative methods for eye irritation ALTEX 28

2011 McNamee P., Declercq L., De Smedt A., De Wever B., Faller C., Harbell J., Jones P., Marrec-Fairley M., Pape W., Pfannenbecker U., Schroeder K., Tailhardat M., Van den Berghe C.and Van Goethem F

European consumer exposure to cosmetic products, a framework for conducting population exposure assessments Part 2

2011 B. Hall , W. Steiling, B. Safford, M. Coroama, S. Tozer, C. Firmani, C. McNamara, M. Gibney,  Food and Chemical Toxicology  

Mathematical models of skin permeability: An overview

2011 Mitragotri S, Anissimov YG, Bunge AL, Frasch HF, Guy RH, Hadgraft J,  Int J Pharm.

Skin sensitisation: the Colipa strategy for developing and evaluating non-animal test methods for risk assessment

2011 Maxwell G, Aeby P, Ashikaga T, Bessou-Touya S, Diembeck W, Gerberick F, ALTEX 28:50-5.

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: genotoxicity A COLIPA analysis

2010 Pfuhler S., et al., Regul Toxicol Pharmacol. 2010 Jul-Aug;57(2-3):315-24. doi: 10.1016/j.yrtph.2010.03.012. Epub 2010 Apr 9.  

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: genotoxicity. A COLIPA analysis

2010 Pfuhler S., Kirst A., Aardema M., Banduhn N., Goebel C., Araki D. , Regul Toxicol Pharmacol 57:315-24.  

Further analysis of Ames-negative rodent carcinogens that are only genotoxic in mammalian cells in vitro at concentrations exceeding 1 mM, including retesting of compounds of concern

2010 Kirkland D., Fowler P., Mutagenesis 25:539-53.  

International prevalidation studies of the EpiDerm 3D human reconstructed skin micronucleus (RSMN) assay: transferability and reproducibility

2010 Aardema MJ., Barnett BC., Khambatta Z., Reisinger K., Ouedraogo-Arras G., Faquet B. , Mutat Res 701:123-31.  

Prospective validation study of reconstructed human tissue models for eye irritation testing

2010 Freeman S.J., Alépée N., Barroso J., Cole T., Compagnoni A., Rubingh C., Eskes C., Lammers J., McNamee P., Pfannenbecker U., Zuang V. , ALTEX. 27 special issue, 261- 266

A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top- Down approaches

2010 Scott L., Eskes C., Hoffmann S., Adriaens E., Alepee N., Bufo M.,  Toxicol In Vitro 24:1-9  

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

2010 Sakaguchi H, Ryan C, Ovigne JM, Schroeder KR, Ashikaga T,  Toxicol In Vitro 24:1810-20.

Responsiveness of human monocyte-derived dendritic cells to thimerosal and mercury derivatives

2010 Migdal C, Tailhardat M, Courtellemont P, Haftek M, Serres M , Toxicol Appl Pharmacol 246:66-73.

Sensitization effect of thimerosal is mediated in vitro via reactive oxygen species and calcium signaling

2010 Migdal C, Foggia L, Tailhardat M, Courtellemont P, Haftek M, Serres M  Toxicology 274:1-9.

Effect of a microemulsion system on hapten-peptide reactivity studies: examples of hydroxycitronellal and citral, fragrance skin sensitizers, with glutathione

2010 Merckel F, Bernard G, Mutschler J, Gimenez-Arnau E, Gerberick GF, Lepoittevin JP Chem Res Toxicol 23:1433-41.

T-cell recognition of chemicals, protein allergens and drugs: towards the development of in vitro assays

2010 Martin SF, Esser PR, Schmucker S, Dietz L, Naisbitt DJ, Park BK, Cell Mol Life Sci 67:4171-84.

Identifying and characterizing chemical skin sensitizers without animal testing: Colipa’s research and method development program

2010 Aeby P, Ashikaga T, Bessou-Touya S, Schepky A, Gerberick F, Kern P,  Toxicol In Vitro 24:1465-73.

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: eye irritation

2009 Mc Namee P., et al.,Regul Toxicol Pharmacol. 2009 Jul;54(2):197-209. doi: 10.1016/j.yrtph.2009.04.004. Epub 2009 Apr 22

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: skin irritation

2009 MacFarlane M., et al.,Regul Toxicol Pharmacol. Jul;54(2):188-96. doi: 10.1016/j.yrtph.2009.04.003. Epub 2009 Apr 22.  

Further development of the EpiDerm 3D reconstructed human skin micronucleus (RSMN) assay

2009 Mun GC., Aardema MJ., Hu T., Barnett B., Kaluzhny Y., Klausner M. , Mutat Res 673:92-9.  

Intralaboratory and interlaboratory evaluation of the EpiDerm 3D human reconstructed skin micronucleus (RSMN) assay

2009 Hu T., Kaluzhny Y., Mun GC., Barnett B., Karetsky V., Wilt N. , Mutat Res 673:100-8.  

Overcoming barriers to validation of non-animal partial replacement methods/integrated testing strategies: The report of an EPAA-ECVAM workshop

2009 Kinser-Ovaskainen A., Akkan Z., Casati S., Coecke, S., Corvi, R., Dal Negro, G., De Bruijn, J., De Silva, O., Gribaldo, L., Griesinger, C., Jaworska, J., Kreysa, J., Maxwell, G., McNamee, P., Price, A., Prieto, P., Schubert, R., Tosti, L., Worth, A., Zuang, V. ,  ATLA. 37, 437-444  

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Eye irritation

2009 McNamee P., Hibatallah J., Costabel-Farkas M., Goebel C., Araki D., Dufour E., Hewitt N .J., Jones P., Kirst A, Le Varlet B, Macfarlane M., Marrec-Fairley M., Rowland J., Schellauf F., Scheel J, Regulatory Toxicology and Pharmacology 54: 197-209  

Mechanistic assessment of peptide reactivity assay to predict skin allergens with Kathon CG isothiazolinones

2009 Mutschler J, Gimenez-Arnau E, Foertsch L, Gerberick GF, Lepoittevin JP, Toxicol In Vitro 23:439-46.

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Skin irritation

2009 Macfarlane M, Jones P, Goebel C, Dufour E, Rowland J, Araki D, Costabel-Farkas M, Hewitt N, Hibatallah J, Kirst A, McNamee P, Schellauf F, Scheel J, Regulatory Toxicology and Pharmacology 54: 188-196

Investigation of peptide reactivity of pro-hapten skin sensitizers using a peroxidase-peroxide oxidation system

2009 Gerberick GF, Troutman JA, Foertsch LM, Vassallo JD, Quijano M, Dobson RL Toxicol Sci 112:164-74.

Selection of chemicals for the development and evaluation of in vitro methods for skin sensitisation testing

2009 Casati S, Aeby P, Kimber I, Maxwell G, Ovigne JM, Roggen E, Altern Lab Anim 37:305-12.

Depletion of human peripheral blood lymphocytes in CD25+ cells allows for the sensitive in vitro screening of contact allergens

2008 Vocanson M, Cluzel-Tailhardat M, Poyet G, Valeyrie M, Chavagnac C, Levarlet B, J Invest Dermatol 128:2119-22.

An Integrated Approach to Testing and Assessment (IATA) to Inform a Theoretical Read-Across for Dermal Exposure to Propylparaben from Cosmetics: a joint case study with Cosmetics Europe

EU ToxRisk Final symposium 2-3 Nov 2021

The HET-MN – An in vitro genotoxicity assay reflecting systemic availability of test compounds

WC 11 Maastricht

AN IN VITRO PANEL FOR COSMETIC CHEMICAL SYSTEMIC TOXICITY SAFETY TESTING

WC 11 MASSTRICHT

Performance statistics of defined approaches for eye hazard identification of liquids to distinguish between the three UN GHS categories

WC 11 MAASTRICHT

Extension of the performance statistics of defined approaches to distinguish between the three UN GHS categories for eye hazard identification and beyond

WC 11 MAASTRICHT

Defining physicochemical exclusion rules to identify chemicals that do not require classification of serious eye damage/eye irritation: a Cosmetic Europe analysis

WC 11 MAASTRICHT

The Threshold of Toxicological Concern (TTC) is a Pragmatic Risk Assessment Tool for the Safety Assessment of Cosmetic Ingredients with Low Consumer Exposure

WC 11 MAASTRICHT

NEW INSIGHTS IN READ ACROSS USING NEW APPROACH METHODS

WC 11 MAASTRICHT

Cosmetics Europe eye program: application of two defined approaches for ocular toxicity predictions based on in vitro bottom up approach on 4 case studies

WC 11 MAASTRICHT

Better understanding of bioavailability of cosmetic ingredients: Results from Cosmetics Europe skin bioavailability project

Eurotox congress, September 2017

State-of-the-art and new options to assess T cell activation by skin sensitizers

SOT meeting, March 2018

Cosmetics Europe evaluation of 6 in silico skin penetration models

SOT meeting, March 2018

Cosmetics Europe Analysis: Towards development of an ocular toxicity Defined Approach using in vitro test methods and physico-chemical properties as components within an IATA

SOT meeting, March 2018

An exposure-led safety assessment framework for systemic toxicity: initial case studies from Cosmetics Europe

SOT meeting, March 2018

Validation and application of the 3D human reconstructed skin micronucleus assay (RSMN) using the EpiDermTM tissue to the safety assessment of cosmetics ingredients

World congress 10 on alternatives to animal testing, August 2017

Cosmetics Europe Eye Programme: Relevance to Integrated Approaches on Testing and Assessment for Serious Eye Damage/Eye Irritation

World congress 10 on alternatives to animal testing, August 2017

Testing Strategies for UN GHS Classification for Serious Eye Damage/Eye Irritation of Chemicals: Cosmetics Europe Analysis

World congress 10 on alternatives to animal testing, August 2017

The importance of understanding physico-chemical properties of chemicals in the evaluation of serious eye damage/eye irritation: Cosmetic Europe analysis

World congress 10 on alternatives to animal testing, August 2017

Cosmetics Europe Long Range Science Strategy for Non-Animal Safety Assessments

World congress 10 on alternatives to animal testing, August 2017

The HET-MN (Hen’s Egg Test for Micronucleus-Induction): Promising pre-validation study

World congress 10 on alternatives to animal testing, August 2017

Bridging the gap from external to internal exposure: use of in silico, PBPK and in vitro methods to predict the biokinetics of topically applied cosmetic ingredients

World congress 10 on alternatives to animal testing, August 2017

Cosmetics Europe Assessment of Non-Animal Approaches for Predicting Skin Sensitization

Eurotox congress, September 2017

In-vitro-only testing strategies for cosmetic ingredients: Utility of newly validated genotoxicity assays using human skin and fertilized hen’s eggs

Eurotox congress, September 2017

LRSS-Long Range Science Strategy Final Report

LRSS – Long Range Science Strategy Programme 2016-2021 Brochure

NON-ANIMAL APPROACHES TO SAFETY ASSESSMENT OF COSMETIC PRODUCTS Cutting-Edge Science and Constant Innovation: The Keys to Success