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Harmonisation of rat fetal skeletal terminology and classification. report of the third workshop on the terminology in developmental toxicology: Berlin, 14–16 September 2000 |
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| Authors: | Roland Solecki, Heinrich Bü rgin, Jochen Buschmann, Ruth Clark, Martine Duverger, Olaf Fialkowski, Pierre Guittin, Keith P. Hazelden, Jü rgen Hellwig, Esther Hoffmann, Thomas Hofmann, Ulrich Hü bel, Samia Khalil, Wolfgang Lingk, AlbertoMantovani, Mary Moxon, Simone Mü ller, Meg Parkinson, Martin Paul, Francisco Paumgartten, Rudolf Pfeil, Thomas Platzek, Martina Rauch-Ernst, Annemarie Scheevelenbos, Jennifer Seed, Chris E. Talsness, Mineo Yasuda, Maged Younes,Ibrahim Chahoud |
| Affiliation: | a Federal Institute for Health Protection of Consumers and Veterinary Medicine, Berlin, Germany b Hoffmann-La Roche AG, Basel, Switzerland c Institute for Toxicology and Aerosol Research, Hannover, Germany d Ruth Clark Associates Ltd., UK e IHE-Section Toxicologie, Brussels, Belgium f Institute of Clinical Pharmacology and Toxicology, Department of Toxicology, Free University Berlin, Berlin, Germany g Aventis Pharma, Centre de Recherche, Vitry sur Seine, France h Huntingdon Life Sciences, Eye, Suffolk, UK i Product Safety-Regulations, Toxicology and Ecology, BASF AG, Ludwigshafen, Germany j Aventis AG, Pharma, Drug Safety Evaluation, Hattersheim, Germany k Byk Gulden, Department Teratology, Hamburg, Germany l Syngenta, Department of Reproductive Toxicology, Stein, Switzerland m Laboratorio di Tossicologia Comparata ed Ecotossicologia, Istituto Superiore di Sanità, Rome, Italy n Central Toxicology Laboratory, Cheshire, UK o Schering AG, Department of Reproductive Toxicology, Berlin, Germany p Glaxo Wellcome Co, Herts, UK q Laboratory of Environmental Toxicology, The National School for Public Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil r Board of the Authorisation of Pesticides, Wageningen, The Netherlands s Environmental Protection, Agency, Washington, DC, USA t Department of Anatomy, Hiroshima University, School of Medicine, Hiroshima, Japan u International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland |
| Abstract: | The initial efforts of the Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV) and the Free University of Berlin to standardise terminology in the field of developmental toxicology began in 1995. Procedures were undertaken to harmonise the terminology used by the International Federation of Teratology Societies (IFTS) and the International Programme on Chemical Safety (IPCS). This article reflects these activities and is a report on the Third Workshop on the Terminology in Developmental Toxicology held in September 2000. This Workshop served as a forum to discuss the results of a survey on the classification of skeletal anomalies that had been previously sent to scientists active in the field. Although high agreement was reached among the evaluators for several terms, the use of a number of terms was rather variable. Therefore, the discussions at the workshop among the experts from research institutions, regulatory agencies, and industry were mainly focussed on those terms for which there was disagreement and/or uncertainties and the possible reasons. Pictures provided by the participants for the illustration of “grey zone” anomalies constituted the basis for detailed discussions. In many of the cases with lower agreement, decisions were facilitated by the provision of the corresponding picture. The main reasons for lower agreement were imprecise terms, insufficient knowledge on postnatal consequences, theoretical terms that are unlikely to occur in isolation, and the possibility of observing a range of severity that might be decisive for the classification of either a malformation or variation. The attendees concluded that “grey-zone” anomalies will never disappear completely and that for the assessment, the grade of severity and/or the frequency of the observation can be decisive for the terminology chosen. A Joint IPCS/IFTS Project was proposed to further consensus of terminology and classification and to link these anomalies to pictures at different skeletal sites. In order to support the harmonisation of regulatory decisions, it was proposed to establish a “Clearinghouse” System under the umbrella of the IPCS. The Clearinghouse could be contacted either by the regulatory authorities or by any company to clarify their queries, particularly with regard to registration or authorisation processes. Finally, it was recommended to also carry out a similar survey on “soft tissue anomalies” and “external findings.” The results of this survey will be discussed at a Joint IPCS/IFTS Workshop in Berlin in 2002. |
| Keywords: | Classification Developmental toxicology Fetal abnormalities Grey zone anomalies Harmonisation Malformation Reproductive toxicology Terminology Variation |
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