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

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• Endpoint:Appearance, behaviour, mortality, food consumption, andbody weight gain of the dams, reproduction parameters,embryotoxicity, foetotoxicity or teratogenicity;• Remarks:Maternal rats: There were no deaths. Cholinergic signs were evident at 21.0mg/kg b.w./day during the dosing period and included tremors, pronepositioning, excitability, leaning/swaying and lower jaw movement.Tremors were reported to occur within 10-60 minutes of dosing. Ratsrecovered following the cessation of dosing. Treatment-related clinical signswere not observed in any other group. The average bodyweight of the 21.0mg/kg b.w./day group was significantly lower (p
• Maternal toxicity NOAEL =• Maternal toxicity LOAEL =3.0 mg/kg b.w./day;21.0 mg/kg b.w./day, based oncholinergic signs, decreased body weightand food consumption.• Developmental toxicity NOAEL = 21.0 mg/kg b.w./day, the highest dosetested;• Developmental toxicity LOAEL was not established.• GLP: US EPA; 40 CFR Part 160;• Test Guideline:• Reference:• Reliability:No information;Tyl RW, Marr MC & Myers CB (1990a) Developmentaltoxicity evaluation of DDVP administered by gavage toCD (Spragues-Dawley) rats. RTI ID No. 60C-4629-10/20.Lab: Reproductive and Developmental ToxicologyLaboratory, Centre for Life Sciences and Toxicology,Chemistry and Life Sciences, Research Triangle Institute,Research Triangle Park, North Carolina, USA. Sponsor:AMVAC Chemical Corporation, Los Angeles, California,USA. Study duration: Unspecified. Report date: 22ndFebruary 1991. Unpublished. (Original not sighted;APVMA, 2008a);Klimisch score 2 = reliable with restrictions;KEY STUDY:• Type of study:• Species:• Strain:• Sex/numbers:Rabbit teratogenicity study;Rabbit;New Zealand White;16 females/group;• Test material: Dichlorvos (Lot No. 802097; 96.86%);• Dose levels:0, 0.1, 2.5, or 7.0 mg/kg b.w./day;Dichlorvos reassessment – application Page 217 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
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 and 176: 7 ACUTE INHALATION 6.1HSNO Classifi
Page 177 and 178: measured and it was not possible to
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: addition, there was an increase in
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 and 266: 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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