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autopsy: distended lung; oedematous and pale, patchy liverwith lobulation; pale spleen and kidney; hyperaemia of theglandular stomach and serosa of the small intestine; andblood and mucus in the gut. No treatmentrelated grosseffects were observed in those animals surviving the 14-day observation period.• LC 50 (aerosol) = 523 mg/m 3 (95% CI 435-632) (0.523 mg/L) for males;447 mg/m 3 (379-529) (0.447 mg/L) in females;• GLP:Yes;• Test Guideline: Stated conforming to OECD [403?];• Reference source:• Reliability:Pauluhn J (1984) ―Dichlorvos (L15/20, DDVP) study foracute inhalation toxicity.‖ Report No. 13124;Lab/Sponsor: Bayer AG Institute of Toxicology,Wuppertal-Eberfeld. Report date: 12th December 1984.(Original not sighted.) (APVMA, 2008a);Klimisch score 2 = reliable with restrictions;Justification for Classification:Pauluhn J (1984) was stated to have been conductedto GLP and Test Guideline, with the APVMA concluding that the quality wasadequate to have confidence in the LC 50 values. The LC 50 values are in line withother reports. LC 50 (mist) = 0.447 mg/L is in Category 6.1B (as a mist) as stated inTable 10.1 of the User Guide to the Thresholds and Classifications in the HSNO Act(ERMA, 2008).BACKGROUND:The APVMA (2006a) reported:―Durham WF, Gaines TB, McCauley RH, Sedlak VA, Mattson AM & Hayes WJJr (1957) Studies on the toxicity of 0, 0-dimethyl-2,2-dichlorovinyl phosphate(DDVP). Arch Ind Health 15: 340-349.―Weanling Sherman rats (10/sex/group) were maintained for two weeks in Peet-Grady chambers that had previously been sprayed once with an emulsioncontaining 2.5% dichlorvos at a rate of approximately 100 or 195 mg dichlorvosper square foot (ie. equivalent to 9.29 or 18.12 mg/m 3 ). Air levels of dichlorvos inthe chamber sprayed at the lower rate ranged from 6 mg/m 3 at the start and 0.1mg/m 3 at the end of the two-week period. No adverse signs or body weightchanges were observed. Plasma and RBC ChE activities were slightly (
measured and it was not possible to determine the inhaled dose from the datapresented. Animals were supplied with food but not water and were removed fromthe chambers for 1 h[our]/day when water was supplied. Incoming and exhaust airwas monitored for dichlorvos by measuring total phosphorus. All animals in alltrials exposed to dichlorvos in the air died, with symptoms including slowlaboured respiration, sialorrhoea and paleness of ears and feet. Under the mostsevere exposure, these signs appeared within 2 h[ours], with average survival time6.9 and 10.1 h[ours] in males and females respectively.―Kimmerle G (1966) Letter re. DDVP (Lo-No. 271) inhalation study. Bayer AGInstitute of Toxicology, 56 Wuppertal-Elberfeld. Ref. Dr.Ki/Sp dated 7thDecember 1966.―A single-page note reported on the LC 50 of dichlorvos in male rats (the sourceand purity of dichlorvos and strain of rat were not provided). Groups of 20animals were exposed to analysed dichlorvos aerosol concentrations of 0.209-1.244 mg/L for 1 h[our], or 0.063-0.544 g/L for 4 h[ours]. In addition, 2 groups ofrats received (theoretical) 0.049 or 0.109 mg/L for 4 h[ours]/d[ay] for 5consecutive days. The 1-h[our] LC 50 was 0.455 mg/L (455 mg/m3), and the 4-h[our] LC 50 was 0.340 mg/L (340 mg/m3). Adverse signs were observed in 3/20rats at 0.319 mg/L and in most animals exposed to 0.479 mg/L or more for 1 h,and in all animals exposed to 0.082 mg/L or more for 4 h[ours]. There were noclinical signs and no animals died in the repeat-dose section of the study.―Macdonald R (1982) Toxicology of consumer products: the acute (4 h)inhalation toxicology of dichlorvos in rats and mice. Document No SBGR.82.145.Lab: Shell Research Ltd, Sittingbourne, UK. Sponsor: Temana. Report date:March 1982 QA study.―Groups of 10 animals (5/sex, CF1 mice and Wistar rats, both from Shell'sTunstall Laboratory) were subjected to head-only exposure to vapour containingdichlorvos (Windmill Plastics Ltd; batch No. ST82/016; 97.8% purity) for 4h[ours]. Observations on health and behaviour were made during and for 14 daysafter exposure. All mice exposed to 218 mg/m 3 (the only dose tested) survived.Adverse signs were body tremors and lethargy, with 3 mice displaying hind limbparesis and all showing splayed gaits. The clinical signs reversed by the secondday. In male rats, 3/10 animals exposed to 250 mg/m 3 (saturated air) died while all10 animals exposed to 210 mg/m 3 died. Subsequent exposure to 142 and 85mg/m 3 resulted in one male death at the lowest concentration. Two furtherexperiments were performed, using concentrations of 206 and 198 mg/m 3 , with nodeaths observed. Adverse signs in rats were observed at the highestconcentrations, and included ataxia and hypersensitivity to noise, both clearingrapidly after exposure. Lethargy persisted for up to 3 days in survivors. Dead ratsshowed signs of respiratory failure but no treatment-related effects were seen insurvivors sacrificed after 14 days. In conclusion, the LC 50 (4 h[our]) fordichlorvos in mice was >218 mg/m 3 and in rats was >206 mg/m 3 . Considerablevariability was evident, with all animals exposed to 210 mg/m 3 dying but nodeaths observed at 206 mg/m 3 .‖ (Originals not sighted; APVMA, 2006a)WHO (1992) reported:Dichlorvos reassessment – application Page 177 of 436
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Application for the Reassessment of
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6.1 Evaluation of options to streng
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EXECUTIVE SUMMARYIn briefERMA New Z
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Aerosol containing 50 g/kgdichlorvo
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ERMA New Zealand‘s recommendation
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26 - 29Outdoor public space usage30
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Substance details1-8,11-16,20-25,30
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1.2.3 In 2008, the Environmental Ri
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Table 1. Dichlorvos-containing subs
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public environments and use for bio
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available to it. In preparing this
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3.3 International regulatory positi
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3.6 Classification3.6.1 The HSNO cl
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Hazard Class /SubclassClassificatio
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Hazard Class /SubclassClassificatio
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Rates:Fogging: 13 ml / litre (water
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BV2 SurfaceInsecticideBV2 SurfaceIn
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Table 7.Dichlorvos outdoor and indo
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Scenario Crop/Use Method Rate Appli
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humidity conditions. The higher res
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4.3 EnvironmentIdentification of ad
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4.3.9.3 Aquatic environment - Groun
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is considered to be highly improbab
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RiskGroupRQ range Level of risk Use
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RiskGroupRQ range Level of risk Use
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assessment, as the Use Scenario inc
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Nonnegligible1 < RQ < 10Nonnegligib
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Table 12.LifecycleStageImport,manuf
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LifecycleStageUse -bystanderUseScen
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Table 13.Identification of benefici
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value that can be attributed to dic
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outbreak, MAF‘s ability to demons
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the duty of the Crown is not merely
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5.1.7.1 J. Hicking stated that dich
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Table 14. Comparative of hazard cla
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Crop Pest Active ingredient Preharv
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Crop Pest Active ingredient Preharv
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SECTION 6- PROPOSALS TO MANAGE RISK
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Assessment was carried out with spe
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6.1.11 Controls to protect bystande
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Table 16Effect of additional contro
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Use Scenario Receptor Level of Risk
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have, and notes the following as ar
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Table 18Summary of benefits associa
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UseScenariosAssessment ofEffectOutc
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Substance detailsHSR000126DDVPInsec
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Table 22.there are no practicable r
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7.4 Preliminary Recommendations7.4.
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method and LOQ)Water (principle ofm
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Appendix B: Environmental Fate of d
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Bioconcentration factor Gnathopogon
Page 125 and 126: Table C.2:Scenarios used in exposur
Page 127 and 128: Scenario 3: Vegetables - 1 applicat
Page 129 and 130: FIELD AND STANDARD POND HALFLIFE VA
Page 131 and 132: insectivorous bird7 Passionfruit Sm
Page 133 and 134: 4 Leafyvegetables(BBCH ≥50)4 Leaf
Page 135 and 136: summer)7 passionfruit(BBCH 10-19)7
Page 137 and 138: Ground (lowboom)0.03 0.03 1.07 1.07
Page 139 and 140: Appendix D: Ecotoxicity of dichlorv
Page 141 and 142: ioaccumulationClearance timeLevel o
Page 143 and 144: Table D.5:Toxicity to terrestrial i
Page 145 and 146: Appendix E: Risk Assessment: Enviro
Page 147 and 148: Aquatic organsimsTable E.3:Environm
Page 149 and 150: 12345Crop type Table I.1 (Annex 1)
Page 151 and 152: 7 passionfruit(BBCH 20-39)7 passion
Page 153 and 154: Fruit (tree) 2052 70759 >50Passionf
Page 155 and 156: Appendix F: Human Toxicity of dichl
Page 157 and 158: CONTENTS:Title Page 11 Purpose 2Con
Page 159 and 160: 2 SUBSTANCE IDENTIFICATIONIUPAC nam
Page 161 and 162: However, dichlorvos has genotoxic p
Page 163 and 164: 4 ABSORPTION, DISTRIBUTION, METABOL
Page 165 and 166: aerosol cans (230-330 g dichlorvos)
Page 167 and 168: 4.3 Metabolism:found in tissues of
Page 169 and 170: dose of 1.0 mg/kg bw, a single gava
Page 171 and 172: eports. LD 50 = 46.4 mg/kg b.w. is
Page 173 and 174: 6 ACUTE DERMAL 6.1HSNO Classificati
Page 175: 7 ACUTE INHALATION 6.1HSNO Classifi
Page 179 and 180: 8 SKIN IRRITATION 6.3 & CORROSION 8
Page 181 and 182: 9 EYE IRRITATION 6.4 & CORROSION 8.
Page 183 and 184: 10 RESPIRATORY SENSITISATION 6.5AHS
Page 185 and 186: Justification for Classification: U
Page 187 and 188: 12 MUTAGENICITY 6.6HSNO Classificat
Page 189 and 190: ERMA New Zealand CONFIDENTIAL Repor
Page 191 and 192: The ATSDR (1997) reported:“Dichlo
Page 193 and 194: •ATSDR (1997): http://www.atsdr.c
Page 195 and 196: 13 CARCINOGENICITY 6.7HSNO Classifi
Page 197 and 198: fibroadenomas were observed in 6 (1
Page 199 and 200: • Sex/Numbers:• Test material:
Page 201 and 202: The NTP Peer Review concluded that:
Page 203 and 204: concurrent studies for comparison w
Page 205 and 206: The APVMA (2008a) reported a chroni
Page 207 and 208: was exposed. The estimated daily in
Page 209 and 210: 14 REPRODUCTIVE TOXICITY 6.8HSNO Cl
Page 211 and 212: ppm during premating days, signific
Page 213 and 214: Toxicology, Chemistry and Life Scie
Page 215 and 216: addition, there was an increase in
Page 217 and 218: • Maternal toxicity NOAEL =• Ma
Page 219 and 220: Research Triangle Park, North Carol
Page 221 and 222: 16 REPRODUCTIVE OR DEVELOPMENTAL TO
Page 223 and 224: 17 SPECIFIC TARGET ORGAN TOXICITY 6
Page 225 and 226: There was a significant dose-relate
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18 SPECIFIC TARGET ORGAN TOXICITY 6
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KEY STUDY:• Type of study:• Spe
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BACKGROUND:The APVMA (2008a) also r
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cholinesterases can only be estimat
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Ltd, Sittingbourne Research Center,
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23 OTHER POTENTIAL TOXIC ENDPOINTS2
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―Results“Mortalities and clinic
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1984). QA study. Study conducted ac
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“No information was located on im
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“Comment: These incidents clearly
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25 ACCEPTABLE OPERATOR EXPOSURE LEV
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to pretreatment activity). When the
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cholinesterase inhibition in health
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protect agricultural workers who ha
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Wash: refers to skin washes; Dressi
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Hazard Class/SubclassHazardclassifi
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Hazard Class/SubclassHazardclassifi
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REFERENCES:APVMA, 2008a. ―DICHLOR
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Appendix 1:APVMA - Summary of bench
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“Inhalational NOEL for Occupation
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activity). In fact, treatment was s
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LAST PAGEDichlorvos reassessment -
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Dichlorvos:Occupational, Bystander,
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CONTENTS:Title Page 11 Purpose 2Con
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3ACTIVITY SCENARIOS3.1 Table (I) su
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access of bystanders to treated are
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can reduce dermal exposures to mixe
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contaminated with, respectively 0.0
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The modelling is based upon dischar
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Table II: Occupational Exposure Est
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Table III: Occupational Exposure Es
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Operation / RPE / PPETable IV: Occu
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1.25L product/ha; work rate, 1.25 h
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Application: Air-hose RPE + chem. r
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Application: Half-face RPE + overal
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P for RPE (% penetration): none, 1
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Table X: Occupational Exposure Esti
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provided: work day exposure is limi
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5POST-APPLICATION OR RE-ENTRY WORKE
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D = DFR x TC x DA x WR x AR x P / B
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Re-entry into out-door crops (Scena
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Re-entry into treated glasshouses d
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acceptable 240 minutes after applic
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Re-entry into treated glasshouses u
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Table XVII: Re-entry into glasshous
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lowest use rate (52 mg/m 3 ; 1300g
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DA = percentage dermal absorption [
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Re-entry into treated enclosed indu
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nature of the building itself, not
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Conclusions on re-entry worker expo
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6BYSTANDER & RESIDENT EXPOSURE & RI
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Children’s incidental ingestion o
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Table XX: Spray driftExposure throu
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Exposure through contactwithcontami
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Conclusions on bystander and reside
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Table XXIII: Dichlorvos Use Scenari
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mixing/loading. Mixing/loading fogg
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7.23 Re-entry for ventilation of in
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REFERENCES:APVMA, 2008a. ―DICHLOR
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Appendix 1:Occupational Exposure Es
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FactorExposure (μg/kg a.i. handled
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Inhalation exposure from cylinder c
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[0.01875 x {(0.018 x 0.05) + (2.68
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With half-face respirator (protecti
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With full-body chemical resistant c
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Appendix 4:Occupational Exposure Es
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With overalls and gloves (protectio
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The Dermal Exposure (D) is 2.06 μg
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TTR = turf transferable residues -
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F = fraction of residue retained on
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TTR = transferable residues - the E
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Public Space ApplicationsScenario (
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ERMA New Zealand‟s comment on the
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Enclosed SpaceAgricultural UseOutdo
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Appendix H: Qualitative Descriptors
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1.3. The likelihood applies to the
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Appendix I: Data from which classif
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Endpoint Units * Dichlorvos Propoxu
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Toxicity mixture calculationsSubcla
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Subclass 9.3 -Ecotoxicity to terres
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Table J.1:Existing controls for dic
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TrackingcontrolsIdentification cont
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Table J.2:Summary of default contro
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Hazardous Substances (Classes 1 to
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Hazardous Substances (Classes 6, 8,
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Hazardous Substances (Classes 6, 8,
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(a) means piping that—(i) is conn
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Code I29 Regs 51, 52 Signage requir
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Non-HSNO Act controlsAgricultural C
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Appendix K: Overseas regulatory act
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Product Use Further details ofuseSu
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Risk assessment identified concerns
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Current usesFormulations:Methods of
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CanadaStatusPMRA are undertaking a
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Appendix L: Parties consulted durin
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Animal Products Act 19995. The purp
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14. Regulatory control of these pro
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Zealand‘s trade in primary produc
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processed and stored. It employs ve
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may be taken to risk management in
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Appendix A• Agricultural Compound
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Appendix O: ReferencesACVM (2010) h
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