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

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11 CONTACT SENSITISATION 6.5BHSNO Classification: Contact sensitisation – 6.5BKEY STUDY:• Type of study:• Species:• Strain:• Sex/Number:• Test Material:• Dose levels:• Endpoint:• Remarks:Maximisation Test;Guinea pig;Dunkin-Hartley;9 females/group;Dichlorvos (source, purity unstated);Induction: 25% dichlorvos;Challenge: 0.005, 0.05 or 0.5% dichlorvos;Skin reactions (erythema and oedema);Nine Dunkin-Hartley female guinea pigs (300-400 g b.w.)were induced topically with 25% dichlorvos underoccluded conditions. Animals were then challenged with0.005, 0.05 or 0.5% dichlorvos and any skin reactionsscored at 24 and 48 hours according to the procedure ofKligman (1966).At 24 hours post-challenge, 0, 56 and 100% of guinea pigstested positive at 0.005, 0.05 or 0.5% dichlorvos,respectively, decreasing to 0, 22 and 67%, respectively, at48 hours. There was a dose-related increase in the grade ofthe reaction.Dichlorvos is concluded to be a skin sensitiser in guineapigs;• GLP:• Test Guideline:No information;No information;• Reference source: Ueda A, Aoyama K, Manda F, Ueda T & Kawahara Y(1994) ―Delayed-type allergenicity of triforine (Saprol®).‖Contact Dermititis 31:140-145. (Original not sighted.)(APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Dichlorvos reassessment – application Page 184 of 436
Justification for Classification: Ueda et al. (1994) was a published study, althoughTest Guideline and GLP status were not reported. The positive response rate wasmore than the minimum threshold as stated in Section 13.2 of the User Guide to theThresholds and Classifications in the HSNO Act (ERMA, 2008), so dichlorvosshould be classified 6.5B for contact sensitisation.BACKGROUND:The APVMA (2008a) reported:―Ueda A, Aoyama K, Manda F, Ueda T & Kawahara Y (1994) Delayed-typeallergenicity of triforine (Saprol®). Contact Dermititis 31:140-145.“Humans: The delayed-type allergenicity of seven pesticides (triforine,dichlorvos, chlorothalonil, quinomethionate, cyhexatin, methomyl and benomyl)and chrysanthemum extracts (known to induce contact dermatitis due to theirsesquiterpene lactones) were studied in 59 male and 48 female chrysanthemumgrowers following the spring harvest season. The average age of males was38.6+11.8 years and the average age of females was 42.2+9.6 years. Subjects hadworked in flower growing for an average of 14 years and had reportedly beenexposed to a range of pesticides. Health information was obtained usingquestionaires (work-related allergies, family history of allergies and general healthinformation). Patch testing of the 7 pesticides and extracts was performed on theinner side of the forearm and reactions read after 2 days. Subjects were alsoanalysed for serum immunoglobulins (IgE, IgA, IgG and IgM).―Approximately 60% of subjects were reported to have one or more work-relatedallergic symptoms (immediate-type or delayed-type), 25% had a personal historyof allergic diseases and 26% a family history of allergic disease. Of the 27% ofsubjects who reported experiencing work-related skin conditions, approximatelyhalf attributed this to pesticides. Pesticides thought to be causative factorsincluded dichlorvos, chlorothalonil, methomyl, maneb and macozeb. Twentypercent of males and 44% of females patch-tested positive to at least one or moreof the compounds. When subjects were patched tested with 0.02% dichlorvos,10% of males (6/59) and 19% of females (9/48) exhibited a positive reaction(average of 14%). On this basis, dichlorvos is concluded to be a skin sensitiser inhumans.‖ (Originals not sighted; APVMA, 2008a)The ATSDR (1997) reported:“A 52-year-old male truck driver who had been hauling pesticide containerspresented with dermatitis of his neck, anterior chest, dorsal hands, andforearms (Mathias 1983). On the previous day, several containers spilled inhis truck, and he apparently had direct dermal contact with a pesticidecontaining 5% dichlorvos, 15% petroleum distillates, and 80%trichloroethane. A faint papular dermatitis was present over the dorsal arms,hands, and V of the neck. .Vertical erythematous, slightly scaling streaks werepresent over the lateral and posterior neck, a pattern suggesting that liquiddroplets had produced the dermatitis. The dermatitis was treated with 1%hydrocortisone ointment. Follow-up examination six weeks later showedDichlorvos reassessment – application Page 185 of 436
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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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 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: 10 RESPIRATORY SENSITISATION 6.5AHS
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
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
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BACKGROUND:The APVMA (2008a) also r
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cholinesterases can only be estimat
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22 SPECIFIC TARGET ORGAN TOXICITY 6
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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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