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Assessment of the potential human health risks from exposure to complex substances in accordance with REACH requirements. "White spirit" as a case study.

Authors
  • McKee, Richard H1
  • Tibaldi, Rosalie2
  • Adenuga, Moyinoluwa D1
  • Carrillo, Juan-Carlos3
  • Margary, Alison3
  • 1 ExxonMobil Biomedical Sciences, Inc., 1545 US Highway 22 East, Annandale, NJ 08801, USA.
  • 2 ExxonMobil Biomedical Sciences, Inc., 1545 US Highway 22 East, Annandale, NJ 08801, USA. Electronic address: [email protected]
  • 3 Shell Health, Shell International B.V., The Hague, The Netherlands. , (Netherlands)
Type
Published Article
Journal
Regulatory toxicology and pharmacology : RTP
Publication Date
Feb 01, 2018
Volume
92
Pages
439–457
Identifiers
DOI: 10.1016/j.yrtph.2017.10.015
PMID: 29069582
Source
Medline
Keywords
License
Unknown

Abstract

The European chemical control regulation (REACH) requires that data on physical/chemical, toxicological and environmental hazards be compiled. Additionally, REACH requires formal assessments to ensure that substances can be safely used for their intended purposes. For health hazard assessments, reference values (Derived No Effect levels, DNELs) are calculated from toxicology data and compared to estimated exposure levels. If the ratio of the predicted exposure level to the DNEL, i.e. the Risk Characterization Ratio (RCR), is less than 1, the risk is considered controlled; otherwise, additional Risk Management Measures (RMM) must be applied. These requirements pose particular challenges for complex substances. Herein, "white spirit", a complex hydrocarbon solvent, is used as an example to illustrate how these procedures were applied. Hydrocarbon solvents were divided into categories of similar substances. Representative substances were identified for DNEL determinations. Adjustment factors were applied to the no effect levels to calculate the DNELs. Exposure assessments utilized a standardized set of generic exposure scenarios (GES) which incorporated exposure predictions for solvent handling activities. Computer-based tools were developed to automate RCR calculations and identify appropriate RMMs, allowing consistent communications to users via safety data sheets.

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