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Review of Chlorpyrifos – Occupational Health & Safety Assessment

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Review of Chlorpyrifos – Occupational Health & Safety Assessment National Registration Authority for Agricultural and Veterinary Chemicals, Australia Section 5 Occupational Health & Safety Assessment 1. INTRODUCTION...............................................................................................................................................3 2. TOXICOLOGY...................................................................................................................................................3 2.1 TOXIC END POINTS.......................................................................................................................................3 2.2 HAZARD CLASSIFICATION............................................................................................................................6 2.3 ONCOGENIC CLASSIFICATION......................................................................................................................7 2.4 REGULATORY STANDARDS..........................................................................................................................8 3. USE PROFILE.....................................................................................................................................................8 3.1 HANDLING PRIOR TO END USE....................................................................................................................8 3.2 USE PATTERN OF END USE PRODUCTS....................................................................................................12 4. OCCUPATIONAL EXPOSURE ASSESSMENT....................................................................................... 33 4.1 MEASURED END USE EXPOSURE STUDIES...............................................................................................33 STUDY DETAILS....................................................................................................................................................... 64 STUDY DETAILS....................................................................................................................................................... 76 DATA COLLECTION AND ANALYSIS ............................................................................................................... 78 RESULTS .................................................................................................................................................................... 79 1 Not to be used for commercial or registration purposes without the consent of the owner of the cited information The NRA Review of Chlorpyrifos – Occupational Health & Safety Assessment GLOSSARY OF TERMS AND ABBREVIATIONS ai Active ingredient bw Body weight d Day g Gram ha Hectare kg Kilogram L Litre m2 Square metre mg Milligram mL Millilitre mg Microgram ng Nanogram ChE Cholinesterase DFR Dislodgeable foliar residues DHAC Department of Health and Aged Care EC Emulsifiable concentrate ECRP Existing Chemicals Review Program EMG Electromyography GPS Geographic Positioning Systems NOEL No Observable Effect Level NOHSC National Occupational Health and Safety Commission OHS Occupational health and safety OP Organophosphorus pesticide OPIDN Organophosphorus induced delayed neuropathy POEM Predictive Operator Exposure Model PPE Personal protective equipment PQ Performance questionnaires RBC Red blood cell REP Restricted-entry Period RfD Reference Dose WHP Withholding Period WP Wettable powder 2 Not to be used for commercial or registration purposes without the consent of the owner of the cited information National Registration Authority for Agricultural and Veterinary Chemicals, Australia 1. INTRODUCTION Chlorpyrifos is an organophosphate pesticide that is widely used in Australia for crop protection and domestic pest control. It also has a minor veterinary use in pet products. Chlorpyrifos is one of the agricultural and veterinary chemicals identified as candidates for priority review under the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) Existing Chemicals Review Program (ECRP). In conducting the occupational health and safety (OHS) review, the National Occupational Health and Safety Commission (NOHSC) obtained information from the following sources: the Department of Health and Aged Care (DHAC) Review of chlorpyrifos, industry submissions, NRA performance questionnaires (PQs) initiated as part of the review of chlorpyrifos, NRA Agriculture Report on chlorpyrifos and the published literature. 2. TOXICOLOGY 2.1 Toxic end points This section describes the main toxicology findings relevant to assigning the toxic end points for the occupational risk assessment. A detailed review of the mammalian toxicology and toxicokinetic/metabolism data on chlorpyrifos is available in the separate toxicology report (DHAC, 1999). Technical chlorpyrifos is of moderate acute toxicity. The lowest oral LD50 is 102 mg/kg bw in mice (96 mg/kg bw in rats), the lowest dermal LD50 is 1580 mg/kg in rabbits and the lowest 3 3 inhalation LC50 is 78 mg/m (65% xylene) or >230 mg/m (4h, undiluted) in rats. Chlorpyrifos is a slight to moderate eye irritant and slight skin irritant in rabbits. It is non-sensitising to guinea pig skin. Female animals were generally more sensitive to the acute effects of chlorpyrifos exposure than male animals. A number of chlorpyrifos formulations have been tested for acute and repeat dose toxicity. The acute toxicity of chlorpyrifos formulations was related to the level of the active ingredient. In repeat dose tests the most sensitive indicator of toxicity was the inhibition of plasma ChE, followed by erythrocyte and then brain ChE. In a number of studies, radiolabelled chlorpyrifos administered orally to rats, was excreted rapidly through the urine (80-90%), faeces (10%) and breath (<1). Analysis of urine for metabolites failed to reveal any unchanged chlorpyrifos. The major urinary metabolites were 3,5,6-trichloro-2-pyridinol (TCP) or its conjugates. Tissue accumulation was shown to be low, with residue levels at 72 h being < 2% of total dose. Tissues with the greatest residue levels were fat, liver, kidney, intestine and ovaries. Rats exposed via inhalation showed similar chlorpyrifos elimination to oral administration. Radiolabelled chlorpyrifos fed to laying hens, goats, pigs and calves also showed low tissue residue levels, with chlorpyrifos residues mainly 3 Not to be used for commercial or registration purposes without the consent of the owner of the cited information The NRA Review of Chlorpyrifos – Occupational Health & Safety Assessment in fat and TCP residues mainly in liver and kidney. In these animals all residues were undetectable 7 days after dosing cessation. Chlorpyrifos is not carcinogenic or genotoxic. In reproductive studies in rats chlorpyrifos did not induce major malformations or significant effects on most reproductive parameters. Developmental studies in mice, rats and rabbits showed foetotoxicity to occur only at maternotoxic doses. Chlorpyrifos did not produce any irreversible neurotoxicological effects when given to hens or rats as a single or repeated dose. The potential to induce organophosphorus induced delayed neuropathy (OPIDN) was demonstrated in hens at about 5 times the oral LD50, however at these doses extensive and aggressive antidote treatment was necessary to keep the birds alive. The overall experimental evidence suggests that chlorpyrifos does not cause delayed neuropathy. Summary of human studies Dow provided the following study as part of the data call-in. Kilian et al. (1970) carried out a series of experiments on seven human volunteers to determine the amount of chlorpyrifos necessary to evoke ChE depression. Dursban 6 Insecticidal Concentrate (61% chlorpyrifos and 34% xylene) was applied to the skin of the back and abdomen, occluded with gauze-adhesive tape and left undisturbed for 12 hours. After this period, the degree of skin irritation was noted and the area washed with soap and water. Blood samples were obtained prior to exposure and for varying periods post-exposure to determine plasma and RBC ChE activity. In the first experiment, five volunteers were dermally exposed to single doses of between 1 and 7.5 mg/kg body weight of the product. Pre-exposure ChE activity was monitored in all subjects. Post-exposure blood samples were obtained 24 hours (5 subjects), 48 hours (3 subjects) and 72 hours (1 subject) after application. Plasma and RBC ChE activity was not significantly depressed following single exposures, under experimental conditions. Following the first experiment, the study authors resorted to multiple dose techniques in order to effect a depression in plasma ChE, as the larger single dose tests required large areas of skin to be treated. The conditions of each subsequent experiment are summarised below. In these experiments, all exposure periods and the period between exposures was 12 hours, respectively. No of subjects, Dose and duration of post- Results No of exposures exposure monitoring One subject, 25 mg/kg No significant depression of plasma or RBC ChE 2 x 12 hrs 4 days One subject 25 mg/kg RBC ChE unaffected, significant depression of 3 x 12 hrs 12 days plasma ChE after 3 doses, levels recovered in 12 days 4 Not to be used for commercial or registration purposes without the consent of the owner of the cited information National Registration Authority for Agricultural and Veterinary Chemicals, Australia One subject 10 mg/kg Minimal RBC and plasma ChE depression 4 x 12 hrs 8 days One subject* 5 mg/kg RBC ChE unaffected, depression of plasma
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