1-,/t., Smifc (Vf.or c' P«i«x»e> end Tome Sufwt.ncw ' nv < ~ • r >- .1 Office o< Peniodt Programs (TS 766CI *¥*'" W«ii..r»gior> DC 2O460 c/EPA Pesticide Fact Sheet Name of Chemical: CARBARYL Reason for Issuance: Registration Standard Date ISSUed: 03/30/84 - Revised 09/05/85 Fact Sheet Number: 21 1. DESCRIPTION OF CHEMICAL Generic Name: 1-Napthyl N-methylcarbamate Con-no i • Maine: Canary! Ti'an? N~>m^. Sevin .".n n .n _ Cono . OS("><(;' • ' Ls bervice ; C^11 Number: 63-25-2 -' .- _ 1 s r [ n I J ) r 1 Q • t ' n- i. ti- j :'roducers. Union Carbide Hakteshim Cnemical <\iorks, ln~. 1. L'^L PATTER'.'- AND KORMU1.ATIO1-.'- A.-ol icni. ic SiLit: 'Jitrij,, u >iv_ , stone and oerry fruits, I'.-aoe, r i •:• i r anc v..' ;otat-i'. -.to,is, nuts, lawns, forests, otnament--. ..i-.ms, ran-j- .on , sn^o- t.ree-3/ poultry and pets, i. 11: ) ) r u •" ^ Types oc ronnulat ions: Bait->, dusts, granules, wettable powders, flowables and aqueou? dispersions Types of rK'-thoos of Application: Ground and aerial Application Rates: Ranye from 0.53 Ibs. a.i./A to 6.4 Ibs. a.i./A Usual Carriers: Synthetic clays, talc, various solvents 3. SCIENCE FINDINGS Summary Science Statement 'arbaryl has moderate to low mammalian toxicity. It is not con- -lered to be an oncogen. It is a weak mutagen. Available data ------- indicates tr a carharyl has o;ily low teratogenic potentiai.. Lon.j terir. dietary studies in rats and dogs and a short tern study in humans (highest dose only) demonstrate an apparent effect on renal function. No reentry interval is necessary for carbaryl. The Agency is requesting data to determine if carbaryl will contaminate groundwater. Data are insufficient to assess the environmental fate of carbaryl. Carbaryl is extremely toxic to aquatic invertebrates and certain estuarine organisms. It is extremely toxic to honey bees. It is moderately toxic to both warrnwater and coidwater fishes and has only low toxicity to birds. A full tolerance reassessment cannot he completed. A one year doj feedmn. study is requirec as well as residue data on nurnerou processe commodities. Chemi cal Character 1st 1 CS Physical Stat : CrystaLline solid Color: Odor: Esseltially odrles Melting po int Vapor Pressure: < 0.005 mm Hg at 26°C Flash Point: 380°F Toxicology Characteristics Acute Oral LD 5 O: 255 mg/kg, loxicity Categor’ ii Acute Dermal LD 50 : > 2 g/k;, Toxicity Category Iii Primary Dermal Irritation: No irritation, Toxicity Category I V Primary Eye Irritation: Conjunctival irritation at 24 hours. Cleared at 48 hours. Toxicity Category III Acute Inhalation LC 50 : Data gap Oncogenicity: Ten studies. Each study classified as Nsupplemental.r Collectively these studies provide sufficient evidence that carbaryl is not oncogenic in experimental ------- animals. Eighteen month mouse study was negative at 400 ppm. A 2 year rat feeding and oncogenicity study was negative at 200 ppm. Teratogenicity: Twenty-four studies have been evaluated to determine the teratogenic potential of carbaryl. In evaluatiri’. these studies some were found to be flawed. Other studies demonstrated no teratogenicity or maternal toxicity. There are studies which demonstrate teratogenic effects although the doses also caused maternal toxicity. Two studies produced teratogenic effects in the beagle dog. These two studies are the primary reason carbaryl was made a candidate for RPAP in 1976. The Agency has concluded (45 FR 81869) that carbaryl does not constitute •a potential human teratogen or reproductive hazar — under groper environmental usage’. The Agency has determinec that the dog is a poor model to use for teratogenicity test1r .. The Agency has determined that a label precaution statin: n3t to use carbaryl on pregnant dogs is warranter Tner’ have been proposals that there are differences in tn m tarr l1sri of carbaryl between the dog and man. Tnes’? difrerences, however, have never been dernonstrate . . Trierefor a met .ar)o11sn study in the beagle dog versus trie r t c ein re uirec. Tnis metabolism study should allow us to deter iin; if tner are meaningful differences between the Coc anc otri r mammalian species. — Reproduction: A rat three generation study was ne ative a 200 :ng/k . riutagenicity: Carharyl is characterized as a weak mutaOen. Tne Agency has determined that carbaryl does not pose a :rluta.4enlc risL. No additional data are being requested. —vear Dog Ieeding Study: :‘—year Rat Feedng Study: Demonstrated an apparent effect on rt na1 function. A kidney effect was also noted in a short— term human study. A one year dog feeding study using carbaryl is being requested in order to determine the effects of carbaryl on kidney dysfunction. The results of these ma’ ’ necessitate a re—evaluation of the ADI for carbaryl. Physiological and Biochemical Behavioral Characteristics Mechanism of Pesticidal Action: A contact insecticide which causes reversible carbamylation of the acetyicholinesterase enzyme of tissues, allowing accumulation of acetylchloline at ------- 4 cnolineraic neuroeffector junctions (muscarinic effects), and at skeletal muscle myoneural junctions and autonomic ganglia. Poisoning also inpairs the central nervous system function. Metabolism and Persistence in Plants and Animals: Carbaryl is rapidly excreted in animals, mainly in the urine. Residues in animals are carbaryl, l—naphthol and hydroxycarbaryl. The hy- droxy rnetabolites are found mainly as glucuronide and sulfate conjugates. Carbaryl is slowly taken up into plants, after which it is metabolized. The disappearance of carbaryl residue from plant surfaces is attributed to mechanical attribution, vol— atization and uptake into plant. Photochemical degradation does not appear to be a factor. l—Naphthol is the major metabolite. Envi ronmental Characteri stics Availar)le data are insufficient to fully assess the environmen— tal fate of carbaryl. Adso pt)Cri and Leaching in Basic Soil Types: The Agency is rejuestin i oato to determine if carbaryl will contaminate r3uraw t r iC:(L1al Breakaown: Carrarl is degraded by fungi. The s’ fun attacL carbaryl b hvdroxvlation of the side chain an rjr structure. Los Lrc fr Photodecomposition: Dat&.gaps. Data are required BioaccurnulatiOfl: Preliminary data indicate that there may be a potential for carharyl and its residue(s) to accumulate ir catfish, crayfish, snail, duckweed and algae. Additional data are requested. ResUltant Averaae Persistanc’ : Carhari s metabolized by pure ann rnixefl cultures of bacteria, funci, and to some ex— L v otne- so i and water organisms. Tne naif—life appears to rari :- fro’r to 28 days in a :rohic ann anaerobic soils, re— s ec tivei, Ecoloa ical Characteristics Avian oral LD 50 - Mallard duck: > 2179 mg/kg Ring necked pheasant: > 2000 mg/kg Avian dietary LC 50 — Mallard duck: > 5000 ppm ------- Pang—necKed pheasant: “ 5000 pprr BoDwhite quail: > 5000 ppr Freshwater Fish LC 50 — Coidwater fish: rainbow trout. — 1.95 pprr Warmwater fish: bluegill sunfish — 6.76 ppm Acute LC 50 Freshwater Invertebrates - Daphnia pulex — 6.4 ppb Acute LC 50 Estuarine and Marine Organisms: Data gap. Data being requested. Freshwater Fish Early Life—Stage — Fathead minnow - Maximum Acceptable Theoretical Concentra- tion (MATC) — >0.21<0.68 ppb No precautionary languaae is required for birds or fish. However, carbaryl is highly toxic to aquatic invertebrates. There is insufficient information to characterize the chronic toxicity of carharyl to aauati invertebrates. Tolerance Assessments The Agency is unable to complets- a fu1 :Dlerance reassessrnen because of certain residue cher’ustr an toxicology data gaps, namely a one year do feeainc stua’ and the need fo:- residue data on various processed rood commodities. Tolerances: Commodity Parts Per Million Alfalfa 100 Alfalfa 100 Almonds Almonds, hulls 40 Apples Apricots 10 Asparagus 10 Bananas 10 Barley, grain o Barley, green fodder 100 Barley, straw 100 Beans 10 Beans, forage 100 Beans, hay 100 Beets, garden (roots) 5 Beets, garden (tops) 12 ------- 6 To. t -anc Commodity Parts Per Million Birdsfoot trefoil, forage 100 Birdsfoot trefoil, hay 100 Blackberries 12 Blueberries Boysenberries 12 Broccoli 10 Brussels sprouts 10 Cabbacje 10 carrots 10 Cauliflower 10 Celery 10 Cnerries 10 Crie tnu:s Chines cahbaae 10 Citrus tru)ts 10 Ciover 100 Ciove , 100 o r .:eEr (lncludlnç sweet) Kerne1(K 5 or lth husk removed(CWHR) • aae . 100 100 - ‘ I aac 100 5 Cow . ra e 100 Cowoe? ., 11a 100 Crannerrier 10 Cucumbers JO DandeliOfl 12 DewDerrieF 12 E i- 1an 10 10 -‘i azelnuts I S ‘ - S Fi , str 10( Grapes 10 Grass 100 Grass, ‘ 100 Horseradis! S Kale 12 iKohirabi 10 Lentils 10 Lettuce 10 oganberries 12 ------- -7 1 ie .anCe : Commodity Parts Per Mil1 ior Maple sap 0.5 Melons 10 Millet, proso, grain 3 Millet, proso, straw ioo Mustara greens 12 Nectarines 10 Oats, fodder, green ioo Oats, grain 0 Oats, straw 100 Okra 10 Olives 10 Oysters 0.25 Parsle 12 rsnip S I U Peanuts 5 t’eanuts, r av 10(1 7E3 ( it.r pOCS 10 100 -, I 1 0 -- nutE 1 : s: r ne 10 :tr’y, La: 5 Du1try, meat S utatoes 0.2(N) Prickly pear cactus, fruit 12.0 ?ri Kly pear cactus, pads 12.0 Pumpkins 10 R3dshe S -, 12 • zra 100 S ( — , areL b c , - , • Ld11 ( I Rye, stra 100 Salsify (roDts) 5 1 i’ (top ’ 10 : iahu , fora e 100 Sorohum, grair 1 10 Soybeans Soybeans, forage ioo Soybeans, hay 100 Spinach 12 Squash, summer 10 Squash, winter 10 ------- Tolerar .E Commodity Parts Per Millior Strawberries 10 Sugar beets, tops ioo Sunflower seeds 1 Sweet potatoes 0.2 Swiss chard 12 Tomatoes 10 Turnips, roots 5 Turnips, tops 12 Walnuts 1 Wheat, fodder, green 100 Wheat (grain) 3 Wheat, straw ioo Cattle, fat 0.1 Cattle, kidney Catt1 , liver Cattle, meat 0.1 Cattle (mbyp) 0.1 Goats, fat Goats, kiane Goats, liver Goats, meat Goats (mt yp Horses, fa Horses, ‘idn- ’ - Horses, 1ive Horses, meat Horses (mbyp Sheep, fat Sheep, kianey Sheep, liver Sheep, meat o. i Sheep (mbyp 0.: Swine, fat o.: Swine, kiane) Swine, 1ve Swine, m a Based on established tolerances the theoretical maxirnwr residue contribution (TMRC) for carhar ’l reslduec 1fl th human diet is calculated to be 5.48 n /da . The acceptable daily intake (ADI) of carbaryl is 0.1 mg/kg/day. Tne max- imum permissible intake (MPI) is 6 mg/day. To provide for conformity between U.S. tolerances for carbaryl and tolerances established by the Codex Alirnentarius , Canada and Mexico, the expression of the U.S. tolerances for carbaryl will be changed to omit reference to l—naphthol. ------- A fl€ year oo feecin study is bein ..j reouestec in oroer tc deterrrine the effects of carbaryl on kidney aysfunctior.. The results of thesc cata may’ require that the A P i for caroary be recalculated. U.S. tolerances for most raw agricultural commodities are supported by current residue chemistry data. Ir some cases, however, more data are required. 4. SUMMARY OF REGULATORY POSITION AND RATIONALE The Agency has determined that it should continue to allow the registration of carbaryl. Adequate studies are available to assess the acute toxicological effects of carbaryl to humans. None of the criteria listed in section 162.11(a) of Title 40 of the U.S. Code of Federal Regulations have been met or exceeded. However, because of gaps in the data base a full risk assessment of carbaryl cannot be completed. full tolerance reassessment cannot be comp1et : Decause of certain residue chemistry and toxicology data ga . namely a one year dog feeding study and the need for resicuE- data or various processed commodities. No feaeral or state reentry intervals have oeen es:az’ l shec for caroarv or will e established. Ava:laDi. a t - are insufficient to fully assess tne env ro-- ment tate o: carbaryl. The Agency is requestinc data to determine i carbaryl will contaminate groundwater. 5. SUMMARY OF MAJOR DATA GAPS Residue data on various processed commodities One year doç feeding study Hycirolysi’ Etua Priotuuegra .a io studies Soil netaD’ Isq studies Mohillt\ S UCACE D1S 5i. t1 stud i Accumulatic’r studiec Metabolisr study in dog versus rat ------- €. COF\1 T PERSC*. A’1 EP Ja S. Ellenberger Product Manager (12) Insecticide—Rodenticide Branch Registration Division (Ts—767c) Office of Pesticide Programs Environn er tal Protection Agency 401 M Street, S. W. Washington, D. C. 20460 Office location and telephone number: Room 202, Crystal Mall *2 1921 Jefferson Davis Highway Arlington, VA 22202 (703) 557—2386 DISCLP IMEI : The information presented in this Chemical Information Fact Sheet is for informational purposes only and ma no be usec to fulfill cata requirements for pesticide rejlstratior anc rereg is t rat br.. ------- |