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Human Health Risk Assessment for Aluminium, Aluminium Oxide, and Aluminium Hydroxide

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Human Health Risk Assessment for Aluminium, Aluminium Oxide, and Aluminium Hydroxide Human health risk assessment for aluminium, aluminium oxide, and aluminium hydroxide. Daniel Krewski, Robert Yokel, Evert Nieboer, David Borchelt, Joshua Cohen, Jean Harry, Sam Kacew, Joan Lindsay, Amal Mahfouz, Virginie Rondeau To cite this version: Daniel Krewski, Robert Yokel, Evert Nieboer, David Borchelt, Joshua Cohen, et al.. Human health risk assessment for aluminium, aluminium oxide, and aluminium hydroxide.. Journal of Toxicology and Environmental Health, Part B: Critical Reviews, Taylor & Francis, 2007, 10 Suppl 1, pp.1-269. 10.1080/10937400701597766. inserm-00289661 HAL Id: inserm-00289661 https://www.hal.inserm.fr/inserm-00289661 Submitted on 22 Jan 2009 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. HUMAN HEALTH RISK ASSESSMENT FOR ALUMINIUM, ALUMINIUM OXIDE, AND ALUMINIUM HYDROXIDE A Report Submitted to the U.S. Environmental Protection Agency February 13, 2007 HUMAN HEALTH RISK ASSESSMENT FOR ALUMINIUM, ALUMINIUM OXIDE, AND ALUMINIUM HYDROXIDE Daniel Krewski1,2, Robert A Yokel3, Evert Nieboer4, David Borchelt5, Joshua Cohen6, Jean Harry7, Sam Kacew2,8, Joan Lindsay9, Amal M Mahfouz10, Virginie Rondeau11 1Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada 2McLaughlin Centre for Population Health Risk Assessment, Institute of Population Health, University of Ottawa, Ottawa, Ontario, Canada 3College of Pharmacy and Graduate Center for Toxicology, University of Kentucky Medical Center, Kentucky, USA 4Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, Ontario, Canada and Institute of Community Medicine, University of Tromsø, Norway 5SantaFe Health Alzheimer's Disease Research Center, Department of Neuroscience, McKnight Brain Institute, University of Florida, USA 6Institute for Clinical Research and Health Policy Studies, Tufts-New England Medical Center, USA 7National Institute of Environmental Health Sciences, NIH, Research Triangle Park, NC, USA 2 8Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada 9Aging-Related Diseases Section, Surveillance Division, Public Health Agency of Canada, Ottawa, Ontario, Canada 10United States Environmental Protection Agency, Washington DC, USA 11INSERM E0338 (Biostatistic), Université Victor Segalen Bordeaux 2, Bordeaux, France Editors: Vic Armstrong, Michelle C Turner McLaughlin Centre for Population Health Risk Assessment, Institute of Population Health, University of Ottawa, Ottawa, Ontario, Canada 3 Corresponding Author: Daniel Krewski Professor and Director McLaughlin Centre for Population Health Risk Assessment University of Ottawa Room 320, One Stewart Street Ottawa, Ontario CANADA K1N 6N5 Tel: 613-562-5381 Fax: 613-562-5380 Email: [email protected] RUNNING TITLE: Aluminium and Human Health KEYWORDS: aluminium, aluminium oxide, aluminium hydroxide, speciation, human health, neurotoxicity, exposure, toxicokinetics, toxicology, epidemiology, Alzheimer’s disease, risk assessment 4 DISCLAIMER: Although the present report is based primarily on peer-reviewed scientific literature, several abstracts of work in-progress have been cited along with some personal communications that were considered by the authors to be of relevance to their task. The authors included all relevant peer-reviewed scientific literature as of September 1, 2006 in their work. However, the conclusions drawn and the assessment of the health risks of aluminium are restricted to information appearing in the scientific peer-reviewed literature. All doses cited in the report are the doses as the Al form administered according to the original study. The manuscript has been reviewed and approved for publication by internal review at the US Environmental Protection Agency. Approval does not signify that the contents necessarily reflect the views and policies of the Agency nor does mention of trade names or commercial products constitute endorsement or recommendation for use. No conflict of interest was declared. 5 ABBREVIATIONS: aerodynamic diameters (dae), alum-treated water (ATW), alveolar macrophages (AM), Alzheimer’s disease (AD), American Conference of Governmental Industrial Hygienists (ACGIH), amyloid precursor protein (APP), amyotrophic lateral sclerosis (ALS), apoliprotein E gene (ApoE), atomic absorption (AA), bacillus calmette-guerin (BCG), blood-brain barrier (BBB), bromodeoxyuridine (BrdU), bronchoalveolar lavage fluid (BALF), body content (Bτ), central nervous system (CNS), cerebrospinal fluid (CSF), Chemical Abstracts Service (CAS), clara cell protein 16 (CC16), clock drawing test (CDT), coal-tar-pitch volatiles (CTPV), computerized tomographic (CT), confidence interval (CI), desferrioxamine (DFO), dialysis associated encephalopathy (DAE), dinitrophenol (DNP), diphtheria toxoid, tetanus toxoid, and pertussis (DTP), electroencephalogram (EEG), electrothermal atomic absorption spectrometry (EAAS), energy dispersive (electron probe) x-ray microanalysis (EDX), energy dispersive x-ray spectrometry (EDXS), erythroid colony forming units (CFU-E) ethylenediaminetetraacetic acid (EDTA), European Economic Union Council (EEC), European Inventory of Existing Commercial Substances (EINECS), event-related potential (ERP-P300), extracellular fluid (ECF), fatty acid (FA), Food and Agriculture Organization (FAO), forced expiratory volume (FEV1), forced vital capacity (FVC), gastric intubation (i.g.), gastrointestinal (GI), glomerular filtration rate (GFR), glucose-6- phosphate dehydrogenase (G6PDH), glutathione (GSH), half life (t½), hepatitis B virus (HBV), histamine provocation test (HPT), immunoglobulin (Ig), inductively-coupled plasma mass spectrometry (ICP-MS), intelligence quotient (IQ), interleukin (IL), International Agency for Research on Cancer (IARC), International Programme on 6 Chemical Safety (IPCS), intramuscular (i.m.), intraperitoneal (i.p.), intravenous (i.v.), job- exposure matrix (JEM), lactate dehydrogenase (LDH), laser microprobe mass analysis (LAMMA), laser microprobe mass spectroscopy (LMMS), limit values for average exposure (VME), macrophagic myofasciitis (MMF), manual metal (MMA), margin of exposure (MOE), mass median aerodynamic diameter (MMAD), maximum contaminant level (MCL), maximum workplace concentration (MAK), mega tonnes (Mt), metal inert- gas (MIG), micro-beam proton-induced X-ray emission (PIXE µbeam), micronucleated polychromatic peripheral erythrocyte (mnPCE), mini-mental state exam (MMSE), minimal risk level (MRL), monocarboxylate-1 (MCT-1), National Institute for Insurance Against Occupational Accidents (INAIL), National Institute for Occupational Safety and Health (NIOSH), neurofibrillary degeneration (NFD), neurofibrillary tangle (NFT), neutron activation analysis (NAA), odds ratio (OR), oxidized glutathione (GSSG), parathyroid hormone (PTH), parathyroidectomy (PTX), Parkinsonism-dementia (PD), particulate matter (PM), permissible exposure limit (PEL), physiologically based pharmacokinetic (PBPK), plasma aluminium concentration (AUC), polycyclic aromatic hydrocarbons (PAH), presenile dementia of the Alzheimer type (PDAT), provisional tolerable weekly intake (PTWI), reactivity limit (RL), recommended exposure limit (REL), reconstituted soft water (RSW), relative risk (RR), risk phrase (R), safety phrase (S), scanning electron microscopy (SEM), secondary ion mass spectrometry (SIMS), short term exposure limit (STEL), sodium aluminium phosphate (SALP), standardized incidence ratio (SIR), standardized mortality ratio (SMR), subcutaneous (s.c.), tetanus toxoid (TT), thiobarbituric acid reactive substances (TBARS), threshold limit value (TLV), thyroparathyroidectomized (TPTX), time-weighted average (TWA), total 7 parenteral nutrition (TPN), total suspended particles (TSP), transferrin (Tf), transferrin- receptor mediated endocytosis (TfR-ME), transmission electron microscopy (TEM), tungsten inert-gas (TIG), tumor necrosis factor (TNF), U.S. Environmental Protection Agency (EPA), U.S. Occupational Safety and Health Administration (OSHA), volume of distribution (Vd), wavelength dispersive X-ray microanalysis (WDX), World Health Organization (WHO), zirconium aluminium glycinate (ZAG) 8 TABLE OF CONTENTS 1 EXECUTIVE SUMMARY ..................................................................................... 16 1.1 IDENTITY, PHYSICAL AND CHEMICAL PROPERTIES, ANALYTICAL METHODS ................................................................................................................... 16 1.2 SOURCES OF HUMAN EXPOSURE............................................................. 16 1.3 ENVIRONMENTAL LEVELS AND HUMAN EXPOSURE......................... 18 1.4 KINETICS AND METABOLISM ................................................................... 19 1.4.1 Humans ..................................................................................................... 19 1.4.2 Animals..................................................................................................... 21 1.5 EFFECTS ON LABORATORY MAMMALS AND IN VITRO TEST SYSTEMS....................................................................................................................
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