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Sulfuryl Fluoride

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Sulfuryl Fluoride 453 SULFURYL FLUORIDE First draft prepared by S. Samuels,1 I. Dewhurst1 and A. Boobis2 1 Pesticides Safety Directorate, Department for Environment, Food and Rural Affairs, Kings Pool, York, England; and 2 Experimental Medicine & Toxicology, Division of Medicine, Faculty of Medicine, Imperial College London, London, England Explanation.................................................................................................. 454 Evaluation for acceptable daily intake......................................................... 454 Biochemical aspects............................................................................... 454 Absorption, distribution and excretion............................................. 454 Oral route ................................................................................... 454 Dermal route............................................................................... 455 Inhalation route........................................................................... 455 Biotransformation....................................................................... 456 Toxicological studies ............................................................................. 460 Acute toxicity................................................................................... 460 General toxicity .......................................................................... 460 Ocular irritation, dermal irritation and dermal sensitization....... 460 Short-term studies of toxicity........................................................... 461 Oral administration..................................................................... 461 Dermal exposure......................................................................... 462 Exposure by inhalation ............................................................... 462 Long-term studies of toxicity and carcinogenicity........................... 478 Genotoxicity..................................................................................... 488 Reproductive toxicity....................................................................... 489 Multigeneration study................................................................. 489 Developmental toxicity............................................................... 495 Special studies.................................................................................. 499 Study screening for acute neurotoxicity ..................................... 499 Short-term study of neurotoxicity with sulfuryl fluoride............ 501 A long-term study screening for neurotoxicity in rats ................ 505 Acute incapacitation in rats ........................................................ 506 Acute physiological parameters in rats....................................... 506 Ultrastructure of the lungs of rats exposed to sulfuryl fluoride at high concentrations ........................................................... 507 Effects in rats treated with calcium gluconate or anti- convulsants............................................................................ 508 Studies with metabolites............................................................. 508 Observations in humans .............................................................................. 511 Plant workers.................................................................................... 511 SULFURYL FLUORIDE 453–522 JMPR 2005 454 Poisoning incidents...........................................................................512 Comments....................................................................................................513 Toxicological evaluation..............................................................................516 References....................................................................................................520 Explanation Sulfuryl fluoride (O2SF2) is a gas used as a fumigant for the control of a range of insect pests. It has been used for structural fumigation since the early 1960s. In the USA it is approved for “food uses” (grain, dried fruit and tree nuts), while in the UK, Germany and Italy the structures being fumigated must be emptied of food items. Sulfuryl fluoride is thought to inhibit the glycolysis and fatty acid cycles via the release of fluoride ions, thereby depriving the insect of energy necessary for survival. Sulfuryl fluoride has not been evaluated previously by the JMPR. All the critical studies contained statements of compliance with good laboratory practice (GLP). Sulfuryl fluoride is sold under the trade names of “Vikane” and “Profume”. Evaluation for acceptable daily intake Sulfuryl fluoride is a gas with a boiling point of minus 55 C (218 K), which makes the performance of studies of oral toxicity difficult. Therefore, all except three of the studies described in this monograph have involved exposure to atmospheres containing sulfuryl fluoride vapour. To convert from concentrations in air to a systemic dose in mg/kg bw per day, account was taken of the respiratory rate and respiratory volume of the animals1 (Zielhuis & van der Kreek, 1979), the duration of exposure (hours per day and days per week) and the proportion (10%) of the inspired dose that was absorbed (based on the toxicokinetic study of Mendrala et al., 2002). In assessing the studies in which sulfuryl fluoride was administered by inhalation, the Meeting agreed that local effects on the respiratory tract were not relevant to the assessment of dietary exposures. However, comments on such local effects are included in this document for completeness. The Meeting agreed the finding of slight dental fluorosis in experimental animals was not an adverse effect. Increases in fluoride concentrations in tissues and blood are considered to be a marker of exposure and not an adverse effect per se. Toxicity and toxicokinetic studies with sulfuryl fluoride have been performed over a period of about 40 years. Most studies contained documentation stating compliance with the principles of GLP and the GLP status of the individual studies is identified in the summary text. All studies are considered to have complied with the basic requirements of the applicable OECD (or equivalent national) test guidelines, unless identified in the summary text. Analysis of concentrations within the inhalation chambers showed that achieved concentrations were equivalent to nominal levels. 1. Biochemical aspects 1.1 Absorption, distribution and excretion (a) Oral route No data were available. 1 Twenty-four h respiratory volumes for test species are: rats, 0.96 m3/kg bw; rabbits, 0.54 m3/kg bw; mice, 1.8 m3/kg bw; and dogs, 0.39 m3/kg bw. SULFURYL FLUORIDE 453–522 JMPR 2005 455 (b) Dermal route No data were available. (c) Inhalation route Rats In a GLP-compliant study, a number of experiments were conducted to determine the biokinetic behaviour and metabolism of sulfuryl fluoride ([35S]sulfuryl fluoride: radiochemical purity, 100%; specific activity, 0.22–0.25 mCi/mmol) in male Fisher F344 rats. Animals were exposed to sulfuryl fluoride via nose-only inhalation, following the protocol outlined in Table 1. The analysis of 35S was by liquid scintillation counting (LSC). The concentration of fluoride ion in the urine of rats exposed to both concentrations of [35S]sulfuryl fluoride was determined by ion selective electrode (ISE). Also, ISE determination of the fluoride ion concentration in the plasma, and the brain and kidney tissue homogenates, of rats exposed to both concentrations of non-radiolabelled sulfuryl fluoride was conducted. Selected samples of urine and faeces were pooled and underwent radiochemical profile analysis for possible metabolite identification. Table 1. Toxicokinetic investigations in male rats exposed to sulfuryl fluoride by inhalation for 4 h Sulfuryl Target dose No. of animals Sampling fluoride Cannulae Not in jugular cannulated vein [35S]Sulfuryl 30 ppm 4 4 Excreta collected in dry-ice cooled traps. Urine: 0 h fluoride (specific (end of exposure) and at 6, 12, 24, 48, 72, 96, 120, 144 activity, & 168 h after exposure. Faeces: 0 h and at 24, 48, 72, 0.26 PCi/l) 96, 120, 144 & 168 h after exposure. Selected tissues collected 7 days after exposure and analysed for radioactivity. Venous blood samples collected via jugular cannulae at 0.25, 0.5, 1, 2, 3 & 4 h during exposure and at 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 120, 144 & 168 h after exposure. When animals killed, blood obtained via cardiac puncture. Blood, urine, and faeces analysed for radioactivity, 35S-labelled fluorosulfate, and sulfate and fluoride (urine and faeces only). [35S]Sulfuryl 300 ppm 4 4 As above fluoride (specific activity 2.8 PCi/l) Unlabelled 30 ppm 0 18 Groups of three rats sacrificed at 2 h (during sulfuryl exposure), at 0 h (end of exposure), and at 2, 4, 8 & fluoride 2 h after exposure. When animals killed, blood obtained via cardiac puncture, and brain and kidney tissues collected and analysed for fluoride ion. Unlabelled 300 ppm 0 18 As above sulfuryl fluoride 0 ppm 0 8 Groups of two rats killed at 4, 0, 4 and 8 h. Blood (control obtained when animals killed, via cardiac puncture. group) From Mendrala et al. (2002) SULFURYL FLUORIDE 453–522 JMPR 2005 456 Achieved atmosphere concentrations were within 10% of nominal values. No animals died during the study. Sulfuryl fluoride was absorbed and excreted rapidly. Excretion was predominantly via the urine (> 80% in 24 h; Table 2). An initial urinary half-life for [35S]sulfuryl fluoride-derived radioactivity was
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