Application for the Reassessment of a Hazardous Substance under ...

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WHO, 1988. ―INTERNATIONAL PROGRAMME ON CHEMICAL SAFETYENVIRONMENTAL HEALTH CRITERIA 79: DICHLORVOS.‖ World HealthOrgnization, Geneva, 1988.WHO, 1993. ―859_ Dichlorvos (Pesticide residues in food 1993 evaluations Part IIToxicology).” World Health Orgnization, Geneva.Dichlorvos reassessment – application Page 268 of 436
Appendix 1:APVMA - Summary of benchmarks used in occupational riskassessments (APVMA, 2008b).“NOELs for Occupational Health & Safety Assessment―Dichlorvos products intended for professional use are most likely to be applied byPCOs [pest control operators], horticulturalists and operators of grain storage facilitiesand flour mills. Depending on pest activity, PCOs may use dichlorvos products onseveral days or daily during the working week. Repeated use of dichlorvos for treatmentof commercial and industrial buildings could result in daily exposure of buildingoccupants, given that dichlorvos has been detected in workplace atmospheres for up to afortnight after application (Schofield, 1993). Grain storage operators and avocadogrowers are more likely to be exposed on a seasonal basis, but also may be exposed onseveral days in succession. Exposure of horticulturalists would be dictated by thegrowth cycle of mushrooms or plants under cultivation, and could occur regularly onsingle days but with several days or more between uses. The most likely potential routesof exposure would be by dermal contact with the undiluted products or spray mixture,and by inhalation of dichlorvos vapour or aerosols.“Dermal NOEL for Occupational Exposure Assessment―Short-term repeat-dose toxicity studies of up to 28 days‘ duration are considered to bethe most appropriate for derivation of NOELs for occupational health and safetyassessment of product users who are exposed repeatedly. The most relevanttoxicological end-point for occupational exposure to dichlorvos is plasma ChEinhibition, as in a repeated exposure scenario, there would be scope for progressivelyincreasing inhibition of plasma ChE activity if the (less sensitive) RBC ChE inhibitionwere used as the pivotal end-point. Although repeat-dose studies via the dermal routewould be optimal for derivation of occupational health and safety NOELs, no suchstudies with dichlorvos are available. The assessment therefore must be performedusing studies undertaken by oral administration. A summary of NOELs determined inoral studies considered adequate for regulatory purposes is shown in the followingtable:Dichlorvos reassessment – application Page 269 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
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Table C.2:Scenarios used in exposur
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Scenario 3: Vegetables - 1 applicat
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FIELD AND STANDARD POND HALFLIFE VA
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insectivorous bird7 Passionfruit Sm
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4 Leafyvegetables(BBCH ≥50)4 Leaf
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summer)7 passionfruit(BBCH 10-19)7
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Ground (lowboom)0.03 0.03 1.07 1.07
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Appendix D: Ecotoxicity of dichlorv
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ioaccumulationClearance timeLevel o
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Table D.5:Toxicity to terrestrial i
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Appendix E: Risk Assessment: Enviro
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Aquatic organsimsTable E.3:Environm
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12345Crop type Table I.1 (Annex 1)
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7 passionfruit(BBCH 20-39)7 passion
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Fruit (tree) 2052 70759 >50Passionf
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Appendix F: Human Toxicity of dichl
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CONTENTS:Title Page 11 Purpose 2Con
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2 SUBSTANCE IDENTIFICATIONIUPAC nam
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However, dichlorvos has genotoxic p
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4 ABSORPTION, DISTRIBUTION, METABOL
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aerosol cans (230-330 g dichlorvos)
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4.3 Metabolism:found in tissues of
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dose of 1.0 mg/kg bw, a single gava
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eports. LD 50 = 46.4 mg/kg b.w. is
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6 ACUTE DERMAL 6.1HSNO Classificati
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7 ACUTE INHALATION 6.1HSNO Classifi
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measured and it was not possible to
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8 SKIN IRRITATION 6.3 & CORROSION 8
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9 EYE IRRITATION 6.4 & CORROSION 8.
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10 RESPIRATORY SENSITISATION 6.5AHS
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Justification for Classification: U
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12 MUTAGENICITY 6.6HSNO Classificat
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ERMA New Zealand CONFIDENTIAL Repor
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The ATSDR (1997) reported:“Dichlo
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•ATSDR (1997): http://www.atsdr.c
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13 CARCINOGENICITY 6.7HSNO Classifi
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fibroadenomas were observed in 6 (1
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• Sex/Numbers:• Test material:
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The NTP Peer Review concluded that:
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concurrent studies for comparison w
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The APVMA (2008a) reported a chroni
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was exposed. The estimated daily in
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14 REPRODUCTIVE TOXICITY 6.8HSNO Cl
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ppm during premating days, signific
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Toxicology, Chemistry and Life Scie
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addition, there was an increase in
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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
Page 233 and 234: KEY STUDY:• Type of study:• Spe
Page 235 and 236: BACKGROUND:The APVMA (2008a) also r
Page 237 and 238: cholinesterases can only be estimat
Page 241 and 242: Ltd, Sittingbourne Research Center,
Page 243 and 244: 23 OTHER POTENTIAL TOXIC ENDPOINTS2
Page 245 and 246: ―Results“Mortalities and clinic
Page 247 and 248: 1984). QA study. Study conducted ac
Page 249 and 250: “No information was located on im
Page 251 and 252: “Comment: These incidents clearly
Page 253 and 254: 25 ACCEPTABLE OPERATOR EXPOSURE LEV
Page 255 and 256: to pretreatment activity). When the
Page 257 and 258: cholinesterase inhibition in health
Page 259 and 260: protect agricultural workers who ha
Page 261 and 262: Wash: refers to skin washes; Dressi
Page 263 and 264: Hazard Class/SubclassHazardclassifi
Page 265 and 266: Hazard Class/SubclassHazardclassifi
Page 267: REFERENCES:APVMA, 2008a. ―DICHLOR
Page 271 and 272: “Inhalational NOEL for Occupation
Page 273 and 274: activity). In fact, treatment was s
Page 275 and 276: LAST PAGEDichlorvos reassessment -
Page 277 and 278: Dichlorvos:Occupational, Bystander,
Page 279 and 280: CONTENTS:Title Page 11 Purpose 2Con
Page 281 and 282: 3ACTIVITY SCENARIOS3.1 Table (I) su
Page 283 and 284: access of bystanders to treated are
Page 285 and 286: can reduce dermal exposures to mixe
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Page 289 and 290: The modelling is based upon dischar
Page 291 and 292: Table II: Occupational Exposure Est
Page 293 and 294: Table III: Occupational Exposure Es
Page 295 and 296: Operation / RPE / PPETable IV: Occu
Page 297 and 298: 1.25L product/ha; work rate, 1.25 h
Page 299 and 300: Application: Air-hose RPE + chem. r
Page 301 and 302: Application: Half-face RPE + overal
Page 303 and 304: P for RPE (% penetration): none, 1
Page 305 and 306: Table X: Occupational Exposure Esti
Page 307 and 308: provided: work day exposure is limi
Page 309 and 310: 5POST-APPLICATION OR RE-ENTRY WORKE
Page 311 and 312: D = DFR x TC x DA x WR x AR x P / B
Page 313 and 314: Re-entry into out-door crops (Scena
Page 315 and 316: Re-entry into treated glasshouses d
Page 317 and 318: 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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