Publication related to RSI or an RSI staff member
The REACH registration process: A case study of metallic aluminium, aluminium oxide and aluminium hydroxide.
The European Union’s REACH Regulation requires determination of potential health and environmental effects of chemicals in commerce. The present case study examines the application of REACH guidance for health hazard assessments of three high production volume (HPV) aluminium (Al) substances: metallic aluminium, aluminium oxide, and aluminium hydroxide. Among the potential adverse health consequences of aluminium exposure, neurotoxicity is one of the most sensitive targets of Al toxicity and the most critical endpoint. This case study illustrates integration of data from multiple lines of evidence into REACH weight of evidence evaluations. This case study then explains how those results support regulatory decisions on classification and labelling. Challenges in the REACH appraisal of Al compounds include speciation, solubility and bioavailability, application of assessment factors, read-across rationale and differences with existing regulatory standards. Lessons learned from the present case study relate to identification and evaluation of toxicologic and epidemiologic data; assessing data relevance and reliability; development of derived no-effect levels (DNELs); addressing data gaps and preparation of chemical safety reports.
Authors
- Willhite, Calvin C, Willhite CC, Risk Sciences International, Ottawa, Canada. Electronic address: calvinwillhite@hotmail.com.
- Karyakina, Nataliya A, Karyakina NA, Risk Sciences International, Ottawa, Canada; McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, Canada. Electronic address: nkaryakina@risksciences.com.
- Nordheim, Eirik, Nordheim E, European Aluminium, Brussels, Belgium.
- Arnold, Ian, Arnold I, International Aluminium Institute, London, United Kingdom; Occupational Health Program, Faculty of Medicine, McGill University, Montreal, QC, Canada.
- Armstrong, Vic, Armstrong V, Risk Sciences International, Ottawa, Canada.
- Momoli, Franco, Momoli F, Risk Sciences International, Ottawa, Canada; McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, Canada; Faculty of Medicine, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
- Shilnikova, Natalia S, Shilnikova NS, Risk Sciences International, Ottawa, Canada; McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, Canada.
- Yenugadhati, Nagarajkumar, Yenugadhati N, Risk Sciences International, Ottawa, Canada; Department of Epidemiology and Biostatistics, College of Public Health and Health Informatics, King Saud bin Abdul-Aziz University for Health Sciences, Riyadh, Saudi Arabia.
- Krewski, Daniel, Krewski D, Risk Sciences International, Ottawa, Canada; McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, Canada; Faculty of Medicine, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
YEAR OF PUBLICATION: 2021
SOURCE: Neurotoxicology. 2021 Mar;83:166-178. doi: 10.1016/j.neuro.2020.12.004. Epub 2020 Dec 5.
JOURNAL TITLE ABBREVIATION: Neurotoxicology
JOURNAL TITLE: Neurotoxicology
ISSN: 1872-9711 (Electronic) 0161-813X (Linking)
VOLUME: 83
PAGES: 166-178
PLACE OF PUBLICATION: Netherlands
ABSTRACT:
The European Union's REACH Regulation requires determination of potential health and environmental effects of chemicals in commerce. The present case study examines the application of REACH guidance for health hazard assessments of three high production volume (HPV) aluminium (Al) substances: metallic aluminium, aluminium oxide, and aluminium hydroxide. Among the potential adverse health consequences of aluminium exposure, neurotoxicity is one of the most sensitive targets of Al toxicity and the most critical endpoint. This case study illustrates integration of data from multiple lines of evidence into REACH weight of evidence evaluations. This case study then explains how those results support regulatory decisions on classification and labelling. Challenges in the REACH appraisal of Al compounds include speciation, solubility and bioavailability, application of assessment factors, read-across rationale and differences with existing regulatory standards. Lessons learned from the present case study relate to identification and evaluation of toxicologic and epidemiologic data; assessing data relevance and reliability; development of derived no-effect levels (DNELs); addressing data gaps and preparation of chemical safety reports.
The European Union's REACH Regulation requires determination of potential health and environmental effects of chemicals in commerce. The present case study examines the application of REACH guidance for health hazard assessments of three high production volume (HPV) aluminium (Al) substances: metallic aluminium, aluminium oxide, and aluminium hydroxide. Among the potential adverse health consequences of aluminium exposure, neurotoxicity is one of the most sensitive targets of Al toxicity and the most critical endpoint. This case study illustrates integration of data from multiple lines of evidence into REACH weight of evidence evaluations. This case study then explains how those results support regulatory decisions on classification and labelling. Challenges in the REACH appraisal of Al compounds include speciation, solubility and bioavailability, application of assessment factors, read-across rationale and differences with existing regulatory standards. Lessons learned from the present case study relate to identification and evaluation of toxicologic and epidemiologic data; assessing data relevance and reliability; development of derived no-effect levels (DNELs); addressing data gaps and preparation of chemical safety reports.
COPYRIGHT INFORMATION: Copyright (c) 2020. Published by Elsevier B.V.
LANGUAGE: eng
DATE OF PUBLICATION: 2021 Mar
DATE OF ELECTRONIC PUBLICATION: 20201205
DATE COMPLETED: 20211126
DATE REVISED: 20211126
MESH DATE: 2021/11/27 06:00
EDAT: 2020/12/09 06:00
STATUS: MEDLINE
PUBLICATION STATUS: ppublish
LOCATION IDENTIFIER: S0161-813X(20)30211-4 [pii] 10.1016/j.neuro.2020.12.004 [doi]
OWNER: NLM
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Chief Risk Scientist
Dr. Daniel Krewski is Chief Risk Scientist and co-founder of Risk Sciences International (RSI), a firm established in 2006 to bring evidence-based, multidisciplinary expertise to the challenge of understanding, managing, and communicating risk. As RSI’s inaugural CEO and long-time scientific...
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Dr. Natalia (Natasha) Shilnikova is a Senior Health Risk Analyst at Risk Sciences International (RSI), where she has contributed since 2011 to some of the organization’s most analytically demanding and policy-relevant projects. With a background in medicine and a PhD...
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