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

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5 ACUTE ORAL 6.1HSNO Classification: Acute oral - 6.1BKEY STUDY:• Type of study: LD 50 ;• Species:• Strain:• Sex/Numbers:Rat;Tif:RAI;5/sex/group;• Test Material: Dichlorvos tech. (purity/source unstated) in 2%carboxymethylcellulose (CMC);• Dose levels:• Endpoint:• Remarks:• LD 50 (mean) =• GLP:• Test Guideline:31.7 to 100 mg/kg b.w. by gavage;Observations for morbidity, mortality, injury & clinicalsigns were conducted. Necropsy examinations wereperformed on all animals found dead and all survivinganimals at the scheduled terminal necropsy;Adverse signs included dyspnoea, exophthalmus, curvedposition, trismus, tonic-clonic muscle spasms and ruffledfur, with these signs occurring at all dose levels within 2hours of administration. These signs increased in severitywith dose. All survivors recovered within 4 days. Grossexamination revealed no treatment-related changes.46.4 mg/kg b.w. (40.1-53.7 mg/kg b.w.), calculated byprobit analysis;No information;No information;• Reference source: Ciba-Geigy Ltd, Basle (1973) ―Acute oral LD 50 oftechnical dichlorvos (G177) in the rat.‖Toxicology/pathology PH 2.635. Report number Siss 3361Report date: 30 th August 1973. (Original not sighted.)(APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Ciba-Geigy (1973) is not stated to have beenconducted to GLP or Test Guidelines, however the LD 50 value is in line with otherDichlorvos reassessment – application Page 170 of 436
eports. LD 50 = 46.4 mg/kg b.w. is in Category 6.1B as stated in Table 10.1 of theUser Guide to the Thresholds and Classifications in the HSNO Act (ERMA, 2008).BACKGROUND:The APVMA (2008a) reported:―Durham WF, Gaines TB, McCauley RH, Sedlak VA, Mattson AM & Hayes WJjr (1957) Studies on the toxicity of 0, 0-dimethyl-2,2-dichlorovinyl phosphate(DDVP). Arch Ind Health 15: 340-349. This published paper reported on a seriesof experiments that investigated a number of endpoints as well as acute oraltoxicity in rats. Dichlorvos was prepared in-house at the Technical DevelopmentLaboratories of the Communicable Disease Centre, Public Health Service, USDepartment of Health, Education and Welfare. Information on the purity of thetest material was not provided. Dichlorvos was given in peanut oil by gavage witha dose volume of 5 mL/kg bw to groups of white Sherman rats (group size notreported). LD50 values were 80 mg/kg bw (95% CI 62-104 mg/kg bw) in malesand 56 mg/kg (48-65 mg/kg bw) in females respectively. All animals that died didso within 1 h of dosing and complete recovery was observed in survivors within24 h. Adverse signs included bulging eyes, lachrymation, sialorrhoea, generalisedmuscle fasciculations and tremors. Convulsions were observed in some animalsprior to death. There was no apparent weight loss amongst survivors. Necropsyand pathology were not reported.‖ (Original not sighted; APVMA, 2008a)WHO (1992) reported:Acute oral toxicity of dichlorvos (WHO, 1988)SpeciesLD 50 (mg/kg b.w.)Mouse 68-275Rat 30-110Rabbit 13-23Cat 28Dog 100-316Chicken 15Swine 157Dichlorvos reassessment – application Page 171 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.
Page 119 and 120: method and LOQ)Water (principle ofm
Page 121 and 122: Appendix B: Environmental Fate of d
Page 123 and 124: Bioconcentration factor Gnathopogon
Page 125 and 126: Table C.2:Scenarios used in exposur
Page 127 and 128: Scenario 3: Vegetables - 1 applicat
Page 129 and 130: FIELD AND STANDARD POND HALFLIFE VA
Page 131 and 132: insectivorous bird7 Passionfruit Sm
Page 133 and 134: 4 Leafyvegetables(BBCH ≥50)4 Leaf
Page 135 and 136: summer)7 passionfruit(BBCH 10-19)7
Page 137 and 138: Ground (lowboom)0.03 0.03 1.07 1.07
Page 139 and 140: Appendix D: Ecotoxicity of dichlorv
Page 141 and 142: ioaccumulationClearance timeLevel o
Page 143 and 144: Table D.5:Toxicity to terrestrial i
Page 145 and 146: Appendix E: Risk Assessment: Enviro
Page 147 and 148: Aquatic organsimsTable E.3:Environm
Page 149 and 150: 12345Crop type Table I.1 (Annex 1)
Page 151 and 152: 7 passionfruit(BBCH 20-39)7 passion
Page 153 and 154: Fruit (tree) 2052 70759 >50Passionf
Page 155 and 156: Appendix F: Human Toxicity of dichl
Page 157 and 158: CONTENTS:Title Page 11 Purpose 2Con
Page 159 and 160: 2 SUBSTANCE IDENTIFICATIONIUPAC nam
Page 161 and 162: However, dichlorvos has genotoxic p
Page 163 and 164: 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: dose of 1.0 mg/kg bw, a single gava
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 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
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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
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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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