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

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The ATSDR (1997) reported:“A number of oral exposure LD50 studies have been done with dichlorvos inrats and mice. Based on reported LD50 values, dichlorvos is considered to beof moderate to high acute toxicity (WHO 1988). In the most extensive studyof this type, dichlorvos was one of 5 chemicals used in a study designed toinvestigate how well an experimentally derived LD50 value would predict thelevel that would result in 1% lethality (LDl value) for CD-l mice (Haley et al.,1975). The LD50 for male mice in this study was calculated to be 139 mg/kg[b.w.], and the LD50 for females was 133 mg/kg [b.w.]. In a subsequent studyat lower doses, the LDl for the male mice was 84 mg/kg [b.w.] (predicted LDlwas 81 mg/kg [b.w.]). In the female mice, the LDl was 95 mg/kg [b.w.](predicted LDl was 106 mg/kg [b.w.]). The authors further estimated an LD0.1of 70 mg/kg [b.w.] for male mice and 82 mg/kg [b.w.] for female mice. AnLD50 of 110 mg/kg [b.w.] was reported in male ICR mice (Takahashi et al.,1987). Dichlorvos administered by gavage in water at a dose of 150 mg/kg[b.w.] to male Swiss mice caused 100% lethality within 9 minutes(Mohammad et al., 1989).―In Sherman rats, oral LD50 values of 80 mg/kg [b.w.] in males and 56 mg/kg[b.w.] in females were reported (Durham et al., 1957). The LD 50 for female Wistarrats was reported to be 58.8 mg/kg [b.w.] (Gajewski and Katkiewicz 1981) and inmale Fischer 344 rats 97.5 mg/kg [b.w.] (Ikeda et al., 1990). Crossbred pigsweighing 12-27 kg treated with dichlorvos in gelatin capsules were reported tohave an LD50 of 157 mg/kg [b.w.] (Stanton et al., 1979).‖ (Original not sighted;ATSDR, 1997)Dichlorvos reassessment – application Page 172 of 436
6 ACUTE DERMAL 6.1HSNO Classification: Acute dermal – 6.1BKEY STUDY:• Type of study: LD 50 ;• Species:• Strain:• Sex/Numbers:• Test Material:• Dose levels:Rat;Sherman;Unstated number/sex/group;Dichlorvos tech. (purity/source unstated) in xylene;Unstated levels to clipped skin;• Endpoint: Mortality (LD 50 );• Remarks: All rats killed by a single dermal dose died within 20minutes of dosage, except a male dosed at 110 mg/kgb.w. that survived for 40 minutes and another maledosed at 125 mg/kg b.w. that survived for 17 days.The symptoms of poisoning observed were bulgingeyes, lacrimation, sialorrhea [excessive salivation],muscle fasciculations, and tremors. Some animals hadconvulsions just before death. Rats that survivedappeared to make a full recovery.• LD50 =• GLP:• Test Guideline:75 mg/kg b.w. in females; 107 mg/kg b.w. in males;No information;No information;• Reference source: Durham WF, Gaines TB, McCauley RH, et al. 1957.“Studies on the toxicity of O,O-dimethyl-2,2-dichlorovinyl phosphate (DDVP).” AMA Arch IndHealth 15:340-349. (Original not sighted.) (ATSDR,1997);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Durham et al. (1957) was not conducted to GLP, andno Test Guideline is reported (but pre-dated such requirements). However, the LD 50value is in line with other reports. LD 50 = 75 mg/kg bw is in Category 6.1B as statedDichlorvos reassessment – application Page 173 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
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 and 170: dose of 1.0 mg/kg bw, a single gava
Page 171: eports. LD 50 = 46.4 mg/kg b.w. is
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
Page 221 and 222: 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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