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

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Critical NOAEL/LOAEL used for occupational exposure health benchmarks (mg/kgb.w./day)= 0.8 c0.1Inhalation InhalationBMDL 10 = 0.8 c (vapours) LOAEL= 0.1 dHuman 21D oral (Gledhill, 1997a &1997b)Inhalation(application)LOAEL = 0.1APVMA (2008b) Dermal NOAEL =0.014Human 28D oral (Rider, 1967)InhalationNOAEL = 0.014abUS EPA;Acute time point;c (0.8 mg/kg bw/day x 0.35kg / 0.34 m 3 /day = 0.8 mg/m 3 );d concentration equivalent = 0.35 mg/m 3 (= 0.1 mg/kg bw/day x 70kg / 20 m 3 /day);Proposed AOEL:AOEL = NOAEL x AF = 0.014 x 1.0 = 0.0014 mg/kg b.w./dayUFs 10From the 28-day human volunteer capsule study (Rider, 1967 in APVMA, 2008aand US EPA, 2006a).Where UFs: inter-species = 1 as the study was carried out in humans; intra-species= 10 to account for individual variability.Based on the current available data package for dichlorvos, TCL has proposed:• dermal absorption at 30% for occupational and bystander/resident health riskmodelling.• inhalation absorption at 100% for occupational and bystander/resident healthrisk modelling.• oral absorption at 100% for occupational and bystander/resident health riskmodelling.Dichlorvos reassessment – application Page 266 of 436
REFERENCES:APVMA, 2008a. ―DICHLORVOS - Toxicology Assessment: The reconsideration ofapprovals of the active constituent, registrations of products containing dichlorvos andapprovals of their associated labels.‖ Australian Pesticides & Veterinary MedicinesAuthority, KINGSTON ACT 2604; 2008.APVMA, 2008b. ―DICHLORVOS - OCCUPATIONAL HEALTH AND SAFETYASSESSMENT: The reconsideration of approvals of the active constituent, registrationsof products containing dichlorvos and approvals of their associated labels.‖ AustralianPesticides & Veterinary Medicines Authority, KINGSTON ACT 2604; 2008.ATSDR, 1997. “TOXICOLOGICAL PROFILE FOR DICHLORVOS” Agency for ToxicSubstances and Disease Registry, Atlanta, Georgia 30333; 1997.CCRIS, 2008. Chemical Carcinogenesis Research Information System (CCRIS) 2008:DICHLORVOS CASRN: 62-73-7.ERMA, 2008. ―User Guide to the Thresholds and Classifications in the HSNO Act.‖v2.0 March 2008: ER-UG-03-2 02/08. ERMA New Zealand, WELLINGTON.IARC, 1991. ―International Agency for Research on Cancer (IARC) - Summaries &Evaluations: DICHLORVOS (Group 2B).‖ VOL.: 53 (1991) (p. 267).http://www.inchem.org/documents/iarc/vol53/06-dichlorvos.htmlPletsa V, Steenwinkel MJ, van Delft JH, Baan RA, Kyrtopoulos SA., 1999. ―Inductionof somatic mutations but not methylated DNA adducts in lambdalacZ transgenic miceby dichlorvos.‖ Cancer Lett. 1999 Nov 15;146(2):155-60.Schop RN, Hardy MH, Goldberg MT., 1990. ―Comparison of the activity of topicallyapplied pesticides and the herbicide 2,4-D in two short-term in vivo assays ofgenotoxicity in the mouse.‖ Fundam Appl Toxicol. 1990 Nov;15(4):666-75.Tungul, A., Bonin, A.M., He, S., Baker R.S.U., 1991. ―Micronuclei induction bydichlorvos in the mouse skin.‖ Mutagenesis vol. 6 no. 5 pp. 405-408, 1991.US EPA, 2000. ―Science Policy on The Use of Data on Cholinesterase Inhibition forRisk Assessments of Organophosphorous and Carbamate Pesticides.‖ August 18, 2000.Office of Pesticide Programs, US Environmental Protection Agency, Washington DC20460.US EPA, 2006a. ―Reregistration Eligibility Decision for Dichlorvos (DDVP).‖ Officeof Pesticide Programs, UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY, WASHINGTON D.C., 20460.US EPA, 2006b. ―Organophosphorus Cumulative Risk Assessment – 2006 Update‖(August 2006) U.S. Environmental Protection Agency, Office of Pesticide Programs.WHO, 1978. ―DICHLORVOS.‖ DATA SHEETS ON PESTICIDES No. 2 (Rev.1)August 1978, World Health Orgnization, Geneva,Dichlorvos reassessment – application Page 267 of 436
Page 1 and 2:
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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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
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: Hazard Class/SubclassHazardclassifi
Page 269 and 270: Appendix 1:APVMA - Summary of bench
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
Page 287 and 288: contaminated with, respectively 0.0
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
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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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