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

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following i.p. administration of single (30 mg/kg [b.w.]) or multiple (10 x 6 mg/kg[b.w.]) doses.Schop RN, Hardy MH, Goldberg MT.Fundam Appl Toxicol. 1990 Nov;15(4):666-75.―Comparison of the activity of topically applied pesticides and the herbicide 2,4-D intwo short-term in vivo assays of genotoxicity in the mouse.‖Department of Biomedical Sciences, University of Guelph, Ontario, Canada.Genotoxicity of eight topically applied compounds was determined using the bonemarrow micronucleus (MN) test and hair follicle nuclear aberration (NA) assay in CD1mice. Twenty-four hours after a single treatment, cyclophosphamide (CY), applied atdoses corresponding to 1/4, 1/8, 1/16, and 1/32 of the published dermal LD50, and N-methyl-N-nitrosourea (MNU), applied at 1/4, 1/8, and 1/16 of the published dermalLD50, were found to increase the incidence of NA in a dose-dependent manner. Thefrequency of MN was significantly increased only at the highest dose of CY. Using thesame protocol, six pesticides applied in dimethyl sulfoxide (DMSO) at doses of 1/8,1/16, and 1/32 of the dermal LD50 were investigated. Aminocarb and chlordaneinduced a dose-dependent increase in the frequency of NA, while there was an observedincrease in NA incidence at only the highest doses of dichlorvos (DDVP), 4,4'-DDT(DDT), and 2,4-dichlorophenoxyacetic acid (2,4-D). No effect was observed withfenitrothion on nuclear aberrations in hair follicles. Except for the highest dose ofchlordane, none of the pesticides tested positive in the bone marrow micronucleus test.Serum cholinesterase levels were reduced to 70 +/- 4.7% of the DMSO control levelwith DDVP, 57 +/- 8.2% with aminocarb, and 60.3 +/- 4.8% with fenitrothion,indicating some systemic activity with these topically applied agents. The data suggestthat aminocarb, chlordane, DDVP, DDT, and 2,4-D are genotoxic as determined by theNA assay and that this assay may be more useful in detecting topically appliedgenotoxic agents than the more often used bone marrow micronucleus test.[Note: the hair follicle nuclear aberration (NA) assay is not currently an acceptedguideline test.]Dichlorvos reassessment – application Page 194 of 436
13 CARCINOGENICITY 6.7HSNO Classification: Carcinogenicity – 6.7BKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:• Test material:Rat combined (chronic toxicity and carcinogenicity);Rat;Fischer 344/N;50/sex/group;Dichlorvos (batch No. SDC 092179; 99% purity);• Dose levels: 0, 4 or 8 mg/kg b.w./day in corn oil, 5 days/week for 103weeks;• Endpoint:• Remarks:Clinical signs, mortality, body weight gain, foodconsumption, clinical chemistry, haematology or urinaryparameters, organ weight, gross/microscopic abnormalitiesand tumour incidences. Plasma and RBC ChE activitieswere measured in a separate experiment;Mild diarrhoea was reportedly treatment-related but therewere no other adverse clinical signs. No treatment-relatedeffects on bodyweight gain or survival were reported.Cytoplasmic vacuolisation of the liver and adrenal cortexwas observed at increased frequency in low-dose (26%)and high-dose (38%) males compared to controls (14%).Adrenal cortical cytoplasmic vacuolisation was alsoobserved in high-dose males (26% compared to 6% incontrols) and low-dose females (34% compared to 9% incontrols).Non-neoplastic and neoplastic lesions of the pancreas wereobserved in both sexes. The incidence of acinarhyperplasia in treated groups of either sex was notsignificantly different from the controls. When crosssectionaland horizontal sectional data were combined, thetotal incidence of adenomas was significantly higher(p
Page 1 and 2:
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
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 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: •ATSDR (1997): http://www.atsdr.c
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
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
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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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