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

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• Species:• Strain:• Sex/Numbers:• Test material:• Dose levels:• Endpoint:Humans;Not applicable;6 males/group;Dichlorvos (AMVAC Chemical Corp., Batch/Lot No.6080028074; 98% purity);7.0 mg/day by capsule for 21 days (for 70kg adult,equivalent to 0.1 mg/kg b.w./day);Symptoms & clinical parameters; RBC ChE activities;clinical chemistry, haematology and urinary parameters;• Remarks: Sporadic symptoms were reported by both treated andplacebo groups, and none were attributed to treatment.A clear time-related increase in the inhibition of RBC ChE activity wasreported, which was not evident in the placebo group. Mean RBC ChE activitywas significantly lower (p
cholinesterase inhibition in healthy male volunteers.‖ (STUDY PROTOCOL)CTL Study No. XH6063. Lab: Zeneca Central Toxicology Laboratory,Alderley Park, Macclesfield, Cheshire, UK and Medeval Limited, Universityof Manchester, Manchester Science Park, Manchester, UK. Sponsor: AMVACChemical Corporation, unspecified location. Study duration: 5 th November1996 to an unspecified time. Report date: unspecified. October 1997. (Originalnot sighted; APVMA, 2008a);• Reliability: Klimisch score 2 = reliable with restrictions;Justification for Key Study status: The study by Gledhill (1997b & 1997c) andMorris (1996b) was conducted to GLP. The USEPA considered the study robustenough to use the NOAEL as basis of their occupational and residential riskassessments.Background:The US EPA have determined that ChE inhibition by organophosphorus pesticidesreaches a steady state after 21 to 28 days exposure (USEPA, 2006b) so these studyperiods are adequate for occupational and bystander/resident risk assessments.The US EPA prefers to use RBC AChE inhibition, because:―Although a pesticide‘s effect(s) on either RBC and plasma cholinesteraseactivity is considered to provide information on its potential to inhibit AChEin the nervous system, data from RBCs, which contain AChE exclusively,may better reflect neuronal AChE inhibition than data from the plasma,which is a variable mixture of butyrylcholinesterase andacetylcholinesterase.‖ (USEPA, 2000).The US EPA also reported levels of AChE inhibition and worker safety:―For example, the California Department of Health Services (CDHS)requires monitoring of agricultural workers who have contact with highlytoxic organophosphorous or carbamate compounds (EPA Toxicity CategoryI or II pesticides; LD 50 # 500 mg/kg in rats)(CDHS, 1988). CDHS removesworkers from the workplace whose plasma levels show 40% or greatercholinesterase inhibition from baseline, or whose red blood cellcholinesterase levels show 30% or greater inhibition. Workers may notreturn until their cholinesterase values return to within 80% of baseline. TheWorld Health Organization (WHO) also has guidelines with the same RBCaction levels (i.e., 30% or greater inhibition), and considers plasmainhibition of 50% of baseline to indicate a "toxic" decrease (Fillmore andLessinger, 1993).‖ (Originals not sighted; USEPA, 2000).The WHO (1987) reported a study where symptoms of poisoning became evident whenhuman subjects reached a dose level of 8 mg/kg b.w. and the RBC cholinesteraseactivity was found 20-55% of normal. Whereas, volunteers undergoing intermittentinhalation exposure that resulted in no inhibition of erythrocyte cholinesterase activity,and the lowest single plasma value observed was 34% of normal reported no illness, noDichlorvos reassessment – application Page 257 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
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
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: to pretreatment activity). When the
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 and 268: REFERENCES:APVMA, 2008a. ―DICHLOR
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
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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
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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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