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

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Endpoint Units * L M N 1N 2 N 3 N 4 N 5 N 6 N 7 N 8 N 9 N 10 N 11 O P QVertebratetoxicityInvertebratetoxicityClassification(MF)Classification(MF)No ND ND ND ND 9.2C 9.3C No ND 9.3C No No 9.3C No No NoND ND ND ND ND ND ND ND ND ND ND ND ND ND ND No* MF – multiplication factor if 9.XADichlorvos reassessment – application Page 388 of 436
Toxicity mixture calculationsSubclass 6.1 Acute toxicity - additivity formula1.1 Using the additivity formula from the ERMA New Zealand User Guide to HSNOThresholds and Classifications the mixture LD 50 calculation for acute oral, dermaland inhalation toxicity for dichlorvos formulations was calculated as follows:Calculated mixture LD 50 =%ComponentLD Component50100Subclass 6.3 Skin Irritation and Subclass 8.2 Skin corrosion1.2 The mechanism for assigning skin irritation/corrosion classification to mixtures(assuming product data are not available) is by analysis of component data, asdescribed in the ERMA New Zealand User Guide to Thresholds and Classification,Table 11.3, Part V, Chapter 11, Page 10. The relevant mixture rules based on thecomposition and hazard profile of the dichlorvos formulations are:1. ∑ 8.2X components ≥ 5%, classify as 8.2X2. ∑ 8.2X components ≥1 but < 5%, classify as 6.3A3. ∑ (10 x 8.2X components) + 6.3A components ≥ 10%, classify as 6.3A.4. ∑ (10 x 8.2X components) + 6.3A components ≥ 1 but < 10%, classify as 6.3B.5. ∑ (10 x 8.2X components) + 6.3A components + 6.3B components ≥ 10%,classify as 6.3B.6. ∑ 6.3A components ≥ 10%, classify as 6.3A.7. ∑ 6.3A components ≥ 1% but < 10%, classify as 6.3B8. ∑ 6.3B components ≥ 10%, classify as 6.3B.Subclass 6.4 Eye Irritation and Subclass 8.3 Eye Corrosion1.3 The mechanism for assigning eye irritation/corrosion classification to mixtures(assuming product data are not available) is by analysis of component data, asdescribed in the ERMA New Zealand User Guide to Thresholds and Classification,Table 12.3, Part V, Chapter 12, Page 12. The relevant mixture rules based on thecomposition and hazard profile of the dichlorvos formulations are:1. ∑ 8.3A components ≥ 3% classify as 8.3A2. ∑ 8.3A components ≥ 1% but > 3%, classify as 6.4A3. ∑ (10 x x8.3A components) + 6.4A components ≥ 10%, classify as 6.4A.4. ∑ 6.4A components ≥ 10%, classify as 6.4A.Dichlorvos reassessment – application Page 389 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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• Maternal toxicity NOAEL =• Ma
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Research Triangle Park, North Carol
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16 REPRODUCTIVE OR DEVELOPMENTAL TO
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17 SPECIFIC TARGET ORGAN TOXICITY 6
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There was a significant dose-relate
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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
Page 337 and 338: Table XX: Spray driftExposure throu
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Page 341 and 342: Conclusions on bystander and reside
Page 343 and 344: Table XXIII: Dichlorvos Use Scenari
Page 345 and 346: mixing/loading. Mixing/loading fogg
Page 347 and 348: 7.23 Re-entry for ventilation of in
Page 349 and 350: REFERENCES:APVMA, 2008a. ―DICHLOR
Page 351 and 352: Appendix 1:Occupational Exposure Es
Page 353 and 354: FactorExposure (μg/kg a.i. handled
Page 355 and 356: Inhalation exposure from cylinder c
Page 357 and 358: [0.01875 x {(0.018 x 0.05) + (2.68
Page 359 and 360: With half-face respirator (protecti
Page 361 and 362: With full-body chemical resistant c
Page 363 and 364: Appendix 4:Occupational Exposure Es
Page 365 and 366: With overalls and gloves (protectio
Page 367 and 368: The Dermal Exposure (D) is 2.06 μg
Page 369 and 370: TTR = turf transferable residues -
Page 371 and 372: F = fraction of residue retained on
Page 373 and 374: TTR = transferable residues - the E
Page 375 and 376: Public Space ApplicationsScenario (
Page 377 and 378: ERMA New Zealand‟s comment on the
Page 379 and 380: Enclosed SpaceAgricultural UseOutdo
Page 381 and 382: Appendix H: Qualitative Descriptors
Page 383 and 384: 1.3. The likelihood applies to the
Page 385 and 386: Appendix I: Data from which classif
Page 387: Endpoint Units * Dichlorvos Propoxu
Page 391 and 392: Subclass 9.3 -Ecotoxicity to terres
Page 393 and 394: Table J.1:Existing controls for dic
Page 395 and 396: TrackingcontrolsIdentification cont
Page 397 and 398: Table J.2:Summary of default contro
Page 399 and 400: Hazardous Substances (Classes 1 to
Page 401 and 402: Hazardous Substances (Classes 6, 8,
Page 403 and 404: Hazardous Substances (Classes 6, 8,
Page 405 and 406: (a) means piping that—(i) is conn
Page 407 and 408: Code I29 Regs 51, 52 Signage requir
Page 409 and 410: Non-HSNO Act controlsAgricultural C
Page 411 and 412: Appendix K: Overseas regulatory act
Page 413 and 414: Product Use Further details ofuseSu
Page 415 and 416: Risk assessment identified concerns
Page 417 and 418: Current usesFormulations:Methods of
Page 419 and 420: CanadaStatusPMRA are undertaking a
Page 421 and 422: Appendix L: Parties consulted durin
Page 423 and 424: Animal Products Act 19995. The purp
Page 425 and 426: 14. Regulatory control of these pro
Page 427 and 428: Zealand‘s trade in primary produc
Page 429 and 430: processed and stored. It employs ve
Page 431 and 432: may be taken to risk management in
Page 433 and 434: Appendix A• Agricultural Compound
Page 435 and 436: Appendix O: ReferencesACVM (2010) h
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