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2. Applying genomics in regulatory toxicology: a report of the ECETOC workshop on omics threshold on non-adversity

Author

Gant, T.W., Auerbach, S.S., von Bergen, Martin, Bouhifd, M., Botham, P.A., Caiment, F., Currie, R.A., Harrill, J., Johnson, K., Li, D., Rouquie, D., van Ravenzwaay, B., Sistare, F., Tralau, T., Viant, M.R., van de Laan, J.W., Yauk, C., Gant, T.W., Auerbach, S.S., von Bergen, Martin, Bouhifd, M., Botham, P.A., Caiment, F., Currie, R.A., Harrill, J., Johnson, K., Li, D., Rouquie, D., van Ravenzwaay, B., Sistare, F., Tralau, T., Viant, M.R., van de Laan, J.W., and Yauk, C.

Abstract

In a joint effort involving scientists from academia, industry and regulatory agencies, ECETOC’s activities in Omics have led to conceptual proposals for: (1) A framework that assures data quality for reporting and inclusion of Omics data in regulatory assessments; and (2) an approach to robustly quantify these data, prior to interpretation for regulatory use. In continuation of these activities this workshop explored and identified areas of need to facilitate robust interpretation of such data in the context of deriving points of departure (POD) for risk assessment and determining an adverse change from normal variation. ECETOC was amongst the first to systematically explore the application of Omics methods, now incorporated into the group of methods known as New Approach Methodologies (NAMs), to regulatory toxicology. This support has been in the form of both projects (primarily with CEFIC/LRI) and workshops. Outputs have led to projects included in the workplan of the Extended Advisory Group on Molecular Screening and Toxicogenomics (EAGMST) group of the Organisation for Economic Co-operation and Development (OECD) and to the drafting of OECD Guidance Documents for Omics data reporting, with potentially more to follow on data transformation and interpretation. The current workshop was the last in a series of technical methods development workshops, with a sub-focus on the derivation of a POD from Omics data. Workshop presentations demonstrated that Omics data developed within robust frameworks for both scientific data generation and analysis can be used to derive a POD. The issue of noise in the data was discussed as an important consideration for identifying robust Omics changes and deriving a POD. Such variability or “noise” can comprise technical or biological variation within a dataset and should clearly be distinguished from homeostatic responses. Adverse outcome pathways (AOPs) were considered a useful framework on which to assemble Omics

Published
2023

9. Contributors

Author

Ahmed, A.R., primary, Allen, M.H., additional, Amlot, P.L., additional, Archer, C.B., additional, Ayala, F., additional, Anne Bach, Marie, additional, Baker, B.S., additional, Berger, C., additional, Berti, E., additional, Bhogal, B., additional, Bjerke, J.R., additional, Black, M.M., additional, Bonifazi, E., additional, Bork, K., additional, Bos, J.D., additional, Botham, P.A., additional, Bourland, A., additional, Braun-Falco, O., additional, Brochier, J., additional, Bröcker, Eva-B., additional, Brüggen, J., additional, Buck, B.E., additional, Budillon, G., additional, Burg, G., additional, Burnham, T.K., additional, Camarasa, J.G., additional, Caputo, R., additional, Carr, M.M., additional, Cats, A., additional, Cavicchini, S., additional, Chapman, D.V., additional, Christophers, E., additional, Claudatus, J.C., additional, Cordier, G., additional, Cottenot, F., additional, Cramers, Marie, additional, Cuomo, R., additional, Cusini, M., additional, Czarnetzki, Beate M., additional, Czernielewski, J., additional, Daha, M.R., additional, De Jong, M.C.J.M., additional, Del Prete, G.F., additional, Demarchez, M., additional, De Nijs, J.A.M., additional, De Panfilis, G., additional, Detmar, U., additional, Dezutter-Dambuyant, C., additional, Djawari, D., additional, Donhuijsen, K., additional, Dubertret, L., additional, Edelson, R., additional, Ely, H., additional, Emsbroek, J.A., additional, Fattorossi, A., additional, Faure, M., additional, Flageul, Beatrice, additional, Fosse, M., additional, Frappez, A., additional, Freytag, W., additional, Fry, L., additional, Garcia Calderón, P., additional, Gaucherand, M., additional, Gawkrodger, D.J., additional, Gebhart, W., additional, Giannotti, B., additional, Grabbe, J., additional, Graham, R.M., additional, Gretenkord, B., additional, Hauck, H., additional, Haneke, E., additional, Happle, R., additional, Harber, L.C., additional, Heinzerling, R.H., additional, Herlin, T., additional, Heyderman, E., additional, Hobbs, Suzanne, additional, Holborow, E.J., additional, Holden, C.A., additional, Holmes, R.C., additional, Horton, J.J., additional, Hunter, J.A.A., additional, Hutterer, J., additional, Isaacson, P.G., additional, Ishikawa, H., additional, Ishikawa, O., additional, James, D.C.O., additional, Jensen, J., additional, Jung, Michaela, additional, Kanerva, L., additional, Kariniemi, Arja-Leena, additional, Kaudewitz, P., additional, Kemeny, D.M., additional, Kind, P., additional, Kleinsmith, D'Anne M., additional, Knop, J., additional, Kohda, M., additional, Blumenkranz, Recia Kott, additional, Kraft, D., additional, Kragballe, K., additional, Krieg, S.R., additional, Krogh, H.K., additional, Lachapelle, J.M., additional, Laquoi, C., additional, Lassmann, H., additional, Lauharanta, J., additional, Leder, L.-D., additional, Leibl, H., additional, Lembo, G., additional, Leonard, J.N., additional, Lessof, M.H., additional, Linder, E., additional, McCarthy, D.A., additional, Macher, E., additional, McKee, P.H., additional, McVittie, E., additional, Mardin, M., additional, Marsden, R.A., additional, Mason, D.Y., additional, Matre, R., additional, Meijer, C.J.L.M., additional, Meneghini, C.L., additional, Monti, M., additional, Morley, J., additional, Moretti, S., additional, Morsches, B., additional, Mynttinen, S., additional, Nadji, M., additional, Niemi, Kirsti-Maria, additional, Norris, D.A., additional, Page, C.P., additional, Paindelli, M.G., additional, Palermo, A., additional, Parkes, P.E., additional, Parolini, F., additional, Parrilli, G., additional, Pelachyk, J.M., additional, Penneys, N.S., additional, Perret, Ch., additional, Pihlman, K., additional, Plosila, M., additional, Poulter, L.W., additional, Powell, F.C., additional, Prost, C., additional, Prunieras, M., additional, Ranki, Annamari, additional, Rantala, I., additional, Reunala, T., additional, Richardson, T.C., additional, Rieber, P., additional, Romani, N., additional, Ross, J.A., additional, Ruiter, D.J., additional, Rumpold, H., additional, Russell-Jones, R., additional, Santoianni, P., additional, Santucci, M., additional, Scheffer, E., additional, Schlaak, H.-E., additional, Schmitt, D., additional, Schopf, R.E., additional, Schrenker, T., additional, Schröder, J.-M., additional, Schroeter, A.L., additional, Schubert, Ch., additional, Schuler, G., additional, Schuller-Petrovic, S., additional, Serri, R., additional, Simon, M., additional, Smith, N.P., additional, Sorg, C., additional, Spaull, J., additional, Staquet, M.J., additional, Stewart, I.C., additional, Stingl, G., additional, Stubb, S., additional, Suter, L., additional, Swain, A.F., additional, Taborsky, U., additional, Tamura, T., additional, Ternowitz, S., additional, Thestrup-Pedersen, K., additional, Thivolet, J., additional, Touraine, R., additional, Tschachler, E., additional, Tuffanelli, D., additional, Unsworth, D.J., additional, Valdimarsson, Helgi, additional, Van der Meer, J.B., additional, van Vloten, W.A., additional, Vermeer, B.J., additional, Vesterinen, E., additional, Viac, J., additional, Villa, A., additional, Wahlström, T., additional, Wallach, D., additional, Westedt, M.L., additional, Wiesner-Menzel, L., additional, Willemze, R., additional, Wojnarowska, Fenella, additional, Wolff, K., additional, Zachariae, H., additional, and Zachary, C.B., additional

Published
1984
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10. Skin irritation and corrosion

Author

Zuang, V., Alonso, M.A., Botham, P.A., Eskes, C., Fentem, J., Liebsch, M., Sandt, J.J.M. van de, and TNO Kwaliteit van Leven

Subjects
safety, in vitro study, Cell Survival, Endpoint Determination, Swine, Food and Chemical Risk Analysis, review, Quantitative Structure-Activity Relationship, Cosmetics, acute toxicity, Animal Testing Alternatives, skin irritation, toxicity testing, Organ Culture Techniques, cell growth, Animals, Humans, Animalia, human, European Union, reproducibility, cosmetic, cell viability, Skin, standardization, corrosion, model, explant, pH measurement, electric resistance, skin water loss, Skin Irritancy Tests, skin culture, animal testing alternative, priority journal, validation process, Consumer Product Safety, chemical structure, Irritants, Chemistry Safety
Published
2005

13. Alternative methods for skin irritation testing: the current status : ECVAM skin irritation task force report 1

Author

Botham, P.A., Earl, L.K., Fentem, J.H., Roguet, R., and Sandt, J.J.M.

Subjects
Corrosion, Keratinocytes, In vitro, Irritation, Health, Human, Skin
Abstract

The ECVAM Skin Irritation Task Force was established in November 1996, primarily to prepare a report on the current status of the development and validation of alternative tests for skin irritation and corrosion and, in particular, to identify any appropriate non-animal tests for predicting human skin irritation which were sufficiently well-developed to warrant ECVAM supporting their prevalidation/validation. The task force based its discussions around the proposed testing strategy for skin irritation/corrosion emanating from an OECD workshop held in January 1996. The following have been reviewed: a) structure-activity and structure-property relationships for skin corrosion and irritation, b) the use of pH and acid/alkaline reserve measurements in predicting skin corrosivity; c) in vitro tests for skin corrosion; d) in vitro tests for skin irritation (keratinocyte cultures, organ cultures, and reconstituted human skin models), and e) human patch tests for skin irritation, It was apparent that, although several promising candidate in vitro tests for skin irritation (for example, reconstituted human skin methods, and human and animal skin organ culture methods) were under development and evaluation, a test protocol, a preliminary prediction model and supporting data on different types of chemicals were only available for a method employing EpiDerm™ . Thus, it is proposed that this EpiDerm test undergoes prevalidation during 1998. In addition, since it was felt preferable to be able to include other in vitro tests in such a prevalidation study, it is recommended that a "challenge" be set to anyone interested in taking part. This involves submitting data on ten test chemicals selected by the task force, obtained according to a standard protocol with a preliminary prediction model, for review by the task force by 31 May 1998.

Published
1998

25. Eye irritation: Reference chemicals data bank

Author

Bagley, D.M., primary, Botham, P.A., additional, Gardner, J.R., additional, Holland, G., additional, Kreiling, R., additional, Lewis, R.W., additional, Stringer, D.A., additional, and Walker, A.P., additional

Published
1992
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34. The discrimination between nickel-sensitive and non-nickel-sensitive subjects by an <em>in vitro</em> lymphocyte transformation test.

Author

Everness, K.M., Gawkrodger, D.J., Botham, P.A., and Hunter, J.A.A.

Subjects
CONTACT dermatitis, ALLERGIES, SKIN inflammation, LYMPHOCYTE transformation, NICKEL sulfide, PETROLATUM, MITOGENS
Abstract

A lymphocyte transformation test (LTT) was able to distinguish between nickel-sensitive subjects and non-nickel-sensitive controls. Sixty-one out of 66 (92%) nickel-sensitive subjects had positive stimulation indices in 6- and/or 7-day assays using 5 /ig/ml of nickel sulphate, whereas none of the 43 controls gave positive results. Stimulation indices were not enhanced by the patch testing of subjects to nickel before performing the LTT. A weak correlation was seen between the results of the LTT and the macroscopic degree of patch-test reactivity. The concentration of nickel sulphate used (5 μg/ml) did not have a significant non-specific mitogenic effect. [ABSTRACT FROM AUTHOR]

Published
1990
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35. Models for contact sensitization--novel approaches and future developments.

Author

Oliver, G.J.A., Botham, P.A., and Kimber, I.

Subjects
CONTACT dermatitis, SKIN inflammation, TOXICITY testing, TOXICOLOGY, DERMATOLOGY
Abstract

Contact sensitization (allergic contact dermatitis) due to natural and synthetic chemicals has been recognized for many years. The underlying immunological process of contact sensitization has been elucidated, but many details of the exact mechanisms and controlling features are still to be determined (Polak, 1980; Turk, 1980). In the majority of instances, contact sensitization is regarded as an adverse, and thus a toxic, response (Cronin, 1980). Over the past 50 years, the growth in the science of toxicology and the practice of toxicity testing has witnessed the development of a number of animal models for identifying the sensitization potential of low molecular weight chemicals. The results from these tests contribute to the decisions which have to be made concerning the health and safety of any population which might be exposed to a given material. The purpose of this article is to comment on the current status of animal models and to indicate where future developments in the assessment of sensitization potential may lie. [ABSTRACT FROM AUTHOR]

Published
1986
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