title: A tiered asthma hazard characterization and exposure assessment approach for evaluation of consumer product ingredients.
abstract: Asthma is a complex syndrome with significant consequences for those affected. The number of individuals affected is growing, although the reasons for the increase are uncertain. Ensuring the effective management of potential exposures follows from substantial evidence that exposure to some chemicals can increase the likelihood of asthma responses. We have developed a safety assessment approach tailored to the screening of asthma risks from residential consumer product ingredients as a proactive risk management tool. Several key features of the proposed approach advance the assessment resources often used for asthma issues. First, a quantitative health benchmark for asthma or related endpoints (irritation and sensitization) is provided that extends qualitative hazard classification methods. Second, a parallel structure is employed to include dose-response methods for asthma endpoints and methods for scenario specific exposure estimation. The two parallel tracks are integrated in a risk characterization step. Third, a tiered assessment structure is provided to accommodate different amounts of data for both the dose-response assessment (i.e., use of existing benchmarks, hazard banding, or the threshold of toxicological concern) and exposure estimation (i.e., use of empirical data, model estimates, or exposure categories). Tools building from traditional methods and resources have been adapted to address specific issues pertinent to asthma toxicology (e.g., mode-of-action and dose-response features) and the nature of residential consumer product use scenarios (e.g., product use patterns and exposure durations). A case study for acetic acid as used in various sentinel products and residential cleaning scenarios was developed to test the safety assessment methodology. In particular, the results were used to refine and verify relationships among tiered approaches such that each lower data tier in the approach provides a similar or greater margin of safety for a given scenario.
authors.affiliation: Department of Environmental Health, University of Cincinnati College of Medicine, Cincinnati, OH, USA. Electronic address: maierma@ucmail.uc.edu.
authors.forename: Andrew
authors.initials: A
authors.lastname: Maier
authors.affiliation: Department of Environmental Health, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
authors.forename: Melissa J
authors.initials: MJ
authors.lastname: Vincent
authors.affiliation: Department of Environmental Health, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: Parker
authors.affiliation: Department of Environmental Health, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
authors.forename: Bernard K
authors.initials: BK
authors.lastname: Gadagbui
authors.affiliation: The LifeLine Group, 4610 Quarter Charge Dr, Annandale, VA, 22003, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Jayjock
mesh_terms: D019342:Acetic Acid / Q000009:adverse effects*; D000818:Animals; D001249:Asthma / Q000139:chemically induced* / Q000175:diagnosis / Q000503:physiopathology; D019985:Benchmarking; D003257:Consumer Product Safety; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination; D004781:Environmental Exposure / Q000009:adverse effects; D006795:Household Products / Q000009:adverse effects*; D006801:Humans; D007509:Irritants / Q000009:adverse effects*; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008962:Models, Theoretical; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards
chemical_list: D007509:Irritants; D019342:Acetic Acid
keywords: Acetic acid; Asthma; Consumer products; Exposure assessment; Hazard characterization; Irritation; Safety assessment; Sensitization; Tiered assessment