Abstract
Only rarely is sufficient toxicological knowledge available on a risk of interest. In cases where toxicological data are incomplete for a specific quantitative risk assessment, the assessment may also draw on general scientific knowledge gained from experience with other chemical substances. However, this approach of extrapolation, using default factors based on empirical evidence, is not without controversy.
References
Bhat VS, Meek MEB, Valcke M, English C, Boobis A, Brown R (2017) Evolution of chemical-specific adjustment factors (CSAF) based on recent international experience; increasing utility and facilitating regulatory acceptance. Crit Rev Toxicol 47:729–749
Chiu WA, Slob W (2015) A unified probabilistic framework for dose-response assessment of human health effects. Environ Health Perspect 123:1241–1254
ECHA (2010) Guidance on information requirements and chemical safety assessment chapter R.8: characterisation of dose [concentration]-response for human health, Version: 2. http://echa.europa.eu/de/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
ECHA, European Chemicals Agency (2019) Appendix to chapter R.8: guidance for preparing a scientific report for health-based exposure limits at the workplace. August 2019. https://echa.europa.eu/documents/10162/23036412/ircsa_r8_appendix_oels_en.pdf/f1d45aca-193b-a7f5-55ce-032b3a13f9d8
Kalberlah F, Schneider K (1998) Quantification of extrapolation factors: final report of the research project No. 116 06 113 of the Federal Environmental Agency. Schriftenreihe der Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, Fb 797, Dortmund/Berlin
Maier A, Lentz TJ, MacMahon KL, McKernan LT, Whittaker C, Schulte PA (2015) State-of-the-science: the evolution of occupational exposure limit derivation and application. J Occup Environ Hyg 12(Suppl 1):S4–S6
Schenk L, Johanson G (2018) Use on uncertainty factors by the European Commission scientific committee on occupational exposure limits: a follow-up. Crit Rev Toxicol 48:513–521
U.S. EPA, U.S. Environmental Protection Agency (2002) A review of the reference dose and reference concentration processes. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, EPA/630/P-02/002F. http://www.epa.gov/raf/publications/review-reference-dose.htm
WHO, World Health Organization (1994) Environmental health criteria 170: assessing human health risks of chemicals, derivation of guidance values for health-based exposure limits. IPCS, International Programme on Chemical Safety, World Health Organization, Geneva
WHO, World Health Organization (2005) Guidance document for the use of data in development of chemical-specific adjustment factors (CSAF) for interspecies differences and human variability in dose/concentration response assessment: IPCS Harmonization Project Document No. 2. http://whqlibdoc.who.int/publications/2005/9241546786_eng.pdf
WHO, World Health Organization (2017) Harmonization project document 11, guidance document on evaluating and expressing uncertainty in hazard characterization, second edition 2017. https://www.who.int/ipcs/methods/harmonization/areas/hazard_assessment/en/
Resources
WHO, World Health Organization (1999) Environmental health criteria 210: principles for the assessment of risks to human health from exposure to chemicals. IPCS, International Programme on Chemical Safety, World Health Organization, Geneva
WHO, World Health Organization (2009) Environmental health criteria 239: principles for modelling dose–response for the risk assessment of chemicals. IPCS, International Programme on Chemical Safety, World Health Organization, Geneva
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2021 Springer-Verlag GmbH Germany, part of Springer Nature
About this entry
Cite this entry
Schneider, K., Ritter, L. (2021). Default Factors in Quantitative Risk Assessment. In: Reichl, FX., Schwenk, M. (eds) Regulatory Toxicology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-36206-4_59-2
Download citation
DOI: https://doi.org/10.1007/978-3-642-36206-4_59-2
Received:
Accepted:
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-36206-4
Online ISBN: 978-3-642-36206-4
eBook Packages: Springer Reference Biomedicine and Life SciencesReference Module Biomedical and Life Sciences