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Application of the margin of exposure (MoE) approach to substances in food that are genotoxic and carcinogenic: EXAMPLE 12: Sudan I (CAS No. 842-07-9)
Authors:Myriam Coulet  Jean-Charles Leblanc  R. Woodrow Setzer
Affiliation:1. Nestlé Research Centre, Switzerland;2. French Food Safety Agency, France;3. US Environmental Protection Agency, NC, USA;1. B-Safe Toxicology Consulting, 31 Hayway, Rushden, Northants NN10 6AG, United Kingdom;2. Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, United States;3. School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom;1. School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang, 110016, China;2. School of Pharmacy, Jilin Medical College, 5 Jilin Street, Fengman District, Jilin, 132013, China;1. French Agency for Food, Environmental and Occupational Health & Safety, 14 rue Pierre & Marie Curie, F-94700, Maisons-Alfort, France;2. Cofrac, 52 rue Jacques Hillairet F-75012 Paris, France;3. Université Paris-Est, Anses, Laboratory for Food Safety, F-94701 Maisons-Alfort, France;4. The French Directorate General for Food, Ministry of Agriculture, Agro-16 Food and Forestry, Paris, France;5. CNRS UMR 7360, University of Lorraine, Metz, France;6. Laboratoire de Toxicologie Génétique, Institut Pasteur de Lille, Lille, France;1. Chemisches und Veterinäruntersuchungsamt (CVUA) Karlsruhe, Weissenburger Strasse 3, D-76187 Karlsruhe, Germany;2. Epidemiological Research Unit, Institute for Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany;3. School of Nursing, Midwifery and Social Care, Edinburgh Napier University, Sighthill Campus, Edinburgh EH11 4BN, Scotland, UK;4. Castle Craig Hospital, Blyth Bridge, West Linton, EH46 7DH Scotland, UK;5. Social and Epidemiological Research (SER) Department, Centre for Addiction and Mental Health, Toronto, Canada;6. Addiction Policy, Dalla Lana School of Public Health, University of Toronto (UofT), Canada;7. PAHO/WHO Collaborating Centre for Mental Health & Addiction, Toronto, Canada;8. Institute of Medical Science, UofT, Canada;1. Risk Assessment Directorate – French Agency for Food Environmental and Occupational Health and Safety (ANSES), Maisons-Alfort, France;2. CNRS Université Paul Verlaine, 57050 Metz, France;3. Laboratoire de Physico-Toxico Chimie des Systèmes Naturels, Université Bordeaux 1, Talence, France;1. U.S. National Institute for Occupational Safety and Health, Cincinnati, USA;2. Centre for Interdisciplinary Studies in Health, Well-being, Society and Environment (CINBIOSE), Université du Québec à Montréal, Canada;3. CHU Sainte-Justine Research Center, Université de Montréal, Canada;4. San Francisco State University, San Francisco, USA
Abstract:Sudan I is generally considered mutagenic based on various in vitro and in vivo tests and is carcinogenic in the rat. Dose-response modelling of the data for hepatocellular adenomas in male rats gave a BMDL10 of 7.3 mg/kg-bw/day. Sudan I is an unauthorised substance that might be present in food intermittently. The great variability and uncertainties in the human exposure data which are country specific, depending on consumption patterns and methodology used, resulted in a large range of MOE values (from 30 to 2,000,000).
Keywords:
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