title: The use of myocardial and testicular end points as a basis for estimating a proposed tolerable daily intake for sodium monofluoroacetate (1080).
abstract: This paper presents the development of a tolerable daily intake (TDI) for sodium monofluoroacetate (1080) using the quantal myocardial and testicular toxicity end points derived from the traditional NOAEL and newer benchmark dose (BMD) methods. 1080 is a highly toxic vertebrate pesticide that has been proven to be effective in controlling possums and other pests. By convention, the TDIs are derived using the traditional no-observed-adverse-effect-level (NOAEL) and applying appropriate default uncertainty factors (UF). In addition to the default UF, a statistically derived UF was also employed in deriving the TDI. The TDIs derived from the NOAEL and BMD approach, 0.075 and 0.10 mg/kg bw/day, respectively, were compared. The resulting TDI estimates using the BMDL, a statistical lower confidence bound on the BMD, were generally consistently slightly higher than those derived using the NOAEL approach. Based on the best fit of modelled dose-response data, a TDI of 0.03 micro g/kg bw/day is proposed for human health risk assessment of 1080.
authors.affiliation: Ministry of Health, Wellington, New Zealand. natalia_foronda@moh.govt.nz
authors.forename: Natalia M
authors.initials: NM
authors.lastname: Foronda
authors.forename: Jefferson
authors.initials: J
authors.lastname: Fowles
authors.forename: Nerida
authors.initials: N
authors.lastname: Smith
authors.forename: Michael
authors.initials: M
authors.lastname: Taylor
authors.forename: Wayne
authors.initials: W
authors.lastname: Temple
authors.forename: Cynthia
authors.initials: C
authors.lastname: Darlington
mesh_terms: D000818:Animals; D019985:Benchmarking / Q000379:methods; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination; D005463:Fluoroacetates / Q000633:toxicity*; D005506:Food Contamination / Q000517:prevention & control / Q000706:statistics & numerical data; D006321:Heart / Q000187:drug effects*; D006801:Humans; D008297:Male; D008452:Maximum Allowable Concentration; D009206:Myocardium / Q000473:pathology; D019055:No-Observed-Adverse-Effect Level; D018570:Risk Assessment / Q000379:methods; D012378:Rodenticides / Q000633:toxicity*; D013737:Testis / Q000187:drug effects* / Q000473:pathology; D035501:Uncertainty
chemical_list: D005463:Fluoroacetates; D012378:Rodenticides; C014815:fluoroacetic acid