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APPENDIX A SAMPLE OF 675 SUBSTANCES AND SUBSAMPLE OF 100 SUBSTANCES FROM THE " SELECT UNIVERSE " me 675 substances in the sample and their CAS Registry numbers (where available) are listed below in randomly ordered sequence within the following seven categories: pesticides and inert ingredients of pesticide formulations, cosmetic ingredients, drugs ana excipients in drug formulations, food additives, and the three production categories of chemicals in commerce as listed in the Inventory of the Toxic Substances Control Act. The chemical names are formatted as they appeared in the lists from which they were selected, with a few minor changes for clarity. Substances that were selected for the subsamole of 100 are ~ 1 _ ~ ~ ~ ~1_ _ _ _ ~ ~ nocea when an asterisk (a). Tne selection process to form the subsample in each category ceased where a solid line appears; it indicates that the required number for the subsample in the given category had been found. An equal sign (=) is used to indicate a word broken for spacing purposes where no hyphen normally occurs. PESTICIDES AND INERT INGREDIENTS OF PESTICIDE FORMULATIONS Chemical CAS number * * * * * * * * Ammonium ligninsulfonate Diethylaminoethanolamine [2,2,2-Trichloro-l-hydroxyethyl) dimethylphosphonate] Alkyldimethylbenzylammonium chloride Carbamic acid, dipropylthio-, _-tert-butyl ester Soap bark 1,2,4-Thiadiazole, 5-ethoxy-3-(trichloromethyl) 1-Butanesulfonothioic acid, S-(chloromethyl) ester Phenol, 4-(di-2-propenylamino)-3,5-dimethyl-, methyl= carbamate (ester) Sulfonated oleic acid, potassium salt 2H-1,3,5-Thiadiazine-2-thione, tetrahydro-3,5-dimethyl Ethanol, 2-butoxy-, phosphate (3:1) Sodium decyldiphenyletherdisulfonate Trichlorobenzyl chloride Benzenecarbothioamide, 2,5-dichloro Citric acid, trisodium salt Benzenamine, compound with 1,3,5-trinitro benzene (1:1) Ethylene thiourea Acetic acid, (2,4-dichlorophenoxy)-, compound with 1,1',1"-nitrilotrisE2-propanol] 4,4'-Bipyridinium, 1,1'-dimethyl-, dichloride Oxirane, methyl-, polymer with oxirane, monobutyl ether Potassium iodate . . 129 . 8061-53 -8 Unava liable 52-68-6 8001-54-4 2212 -63 -7 Unava liable 2593-15-9 16008-31-4 6392-46-7 Unava liable 533-74-4 78-51-3 36445-71-3 1344-32-7 69622-81-7 68-04-2 3101-79 -9 96-45-7 32341-80-3 1910-42-5 9038-95-3 7758-05-6

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PESTICIDES AND INERT INGREDIENTS OF PESTICIDE FORMULATIONS, continued Pyridine Phosphorodithioic acid, S-(chloromethyl) O,O-, diethyl ester 2,3,5-Trichloro-4-(propylsulfonyl~pyridine * p-Benzoquinone Glycine, N-~2-[bistcarboxymethyl~aminoJethyl) N-~2-hydroxyethyl)-, trisodium salt 2-Propanamine, sulfate * p-Nitrophenyldimethylthionophosphate 2,4-Dichlorophenoxyacetic acid, alkylamine salt * Sodium acetate Agrobacterium radiobacter , Carbamic acid, dimethyl-, 3-methyl-1-phenyl lH-pyrazol-5-yl ester Carbonic acid, methyl 2-~1-methylheptyl)-, 4,6-dinitrophenyl ester * Phosphorodithioic acid, O,O-dimethyl ester, S-ester with N-(mercaptomethyl~phthalimide * C.I. Pigment green 21 (Copper acetoarsenite, solid) . . . . 2,5-Cyclohexediene-1,4-dione, 2,3,5,6-tetrachloro- 118-75-2 Mercury, (acetato-O) (methylphenyl)- 1300-78-3 Copper hydroxide [Cu(OH)2] 20427-59-2 Acetic acid, (2,4-dichlorophenoxy)-, methyl-2-(methyl- 53535-28-7 2-Emethyl-2-~2-methylpropoxy~ethoxy]-ethoxy~ethyl ester Phenarsezine, 10,10'-oxybis[5,10-dihydro Alkyldimethylbenzylammonium chloride Benzoic acid, 2-hydroxy-, compound with 4-chloro= benzenamine (1:1) N-~2-~2-Hydroxyethoxypoly~ethyleneoxy~polypropylene= oxy)]propyl~hexanamide Heptadecenylimidazoline Benzenamine, ar,ar-dichloro Sulfuric acid, zinc salt (1:1), monohydrate Sodium pentaborate 1~-Imidazot4,5-b~pyridine, 6-chloro-2-(trifluoromethyl) [l,l'-Biphenyl]-2-ol, a~mnonium salt 110-86-1 24934-91-6 38827-35-9 106-51-4 139-89-9 60828-92-4 297-97-2 Unavailable 127-09-3 Unavailable 87-47-8 5386-68-5 732-11-6 1~'002-03-8 COSMETIC INGREDIENTS Poloxamine 1301 Sucrose benzoate/sucrose acetate isobutyrate Acetylated lanolin ricinoleate PEG-70 hydrogenated lanolin 130 4095-45-8 8001-54-5 53404-66-3 Unavailable Unavailable 27134-27-6 7446-19-7 Unavailable 13577-71-4 52704-98-0 11111-34-5 Unavailable 977055-85-8 68648-27-1

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COSMETIC INGREDIENTS Chemical CAS Number - * Maleic acid Pareth-91-8 Methylpropylcellulose Safflower glyceride PEG-30 glyceryl oleate Octadecene/maleic anhydride copolymer * FD & C Red No. 40 Ammonium phosphate PPG-8-ceteth-10 * 4,4'-Isopropylidenediphenol * Ethyl linolenate Allantoin calcium pantothenate Nonoxynol-8 * * * * * * * * Calcium acetate Sucrose benzoate Laureth-3 Potassium oleate PEG-100 stearate Cocamine oxide Sodium myristyl sulfate Tetrasodium EDTA Cetearyl alcohol Dimethyl cocamine p-Cresol DM Hydantoin Isosteareth-6 carboxylic acid Dehydroacetic acid Spinach extract Benzophenone-11 PEG-200 Guanidine carbonate PPG-2 methyl ether D & C Orange No. 5 zirconium lake Hydrogenated tallow amine oxide * Sodium bromate Barium sulfide Oleth-15 Phloroglucinol Zinc myristate Acetylated glycol stearate Vinylpyrrolidone/vinyl acetate/itaconic Sorbitan triisostearate PEG-14 oleate 131 110-16-7 68439-46-3 977057-25-~ 977058-10-8 68889-49-6 25266-02-8 25956-17-6 7722-76-1 9087-53-0 80-05-7 1191-41-9 4207-41-4 26027-38-3 37205-87-1 62-54-4 12738-64-6 3055-94-5 143-18-0 9004-99-3 61788-90-7 1191-50-0 64-02-8 8005-44-5 61788-93-0 106-44-5 77-71-4 Unavailable 520-45-6 Unavailable 1341-54-4 25322-68-3 593-85-1 13429-07-7 37 ~ 86-64-9 977054-31-1 61788-94-1 7789-38-0 21109-95-5 9004-98-2 25190-05-0 108-73-6 16260-28-8 Unavailable 68928-72-3 54392-27-7 9004-96-0

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COSMETIC INGREDIENTS, continued Chemical , CAS Number Honey extract Quaternium-8 * Trisodium EDTA PEG-45 stearate Acetylated hydrogenated tallow glycerides Trioleth-8 phosphate * Zinc carbonate , Glyceryl tri-C10_lg acids Potassium iodide Benzophenone-7 Ethylene brassylate Sodium monodiethylaminopropyl cocoaspartate Nonoxyno1-4 Ceteareth-17 Ammonium myreth sulfate Poloxamine 908 Isostearamidopropyl dimethylamine lactate Ditridecyl sodium sulfosuccinate Styrene/maleic anhydride copolymer ~ e Grape Julce FD & C Green No. 3 Corn poppy extract PEG-8 oleate Unavailable 977066-07-1 150-38-9 9004-99-3 977063-59-4 977058-53-9 3486-35-9 Unavailable 7681-11-0 85-19-8 105-95-3 977068-51-1 7311-27-5 977063-70-9 27731-61-9 11111-34-5 55852-15-8 2673-22-5 9011-13-6 977064-74-6 2353-45-9 Unavailable 9004-96-0 977055-26-7 101-54-2 39464-69-2 8014-29-7 977064-18-8 104-98-3 68439-53-2 75-31-0 68989-01-5 61788-85-0 8016-70-4 977068-15-7 557-04-0 31692-79-2 9087-53-0 633-96-5 75-57-0 144-55-8 977067-59-6 ~5322-68-3 28474-90-0 1643-20-5 Unavailable N-Phenyl-~-phenylenediamine Oleth-4-phosphate Rue oil Decyl mercaptomethylimidazole Urocanic acid PPG-20 lanolin ether Isopropylamine Quaternium-3 PEG-7 hydrogenated castor oil Hydrogenated soybean oil Cll_l3 isoparaffin Magnesium stearate Dimethiconol PPG-4-ceteth-5 D & C Orange No. 4 Tetramethylammonium chloride Sodium bicarbonate Sorbitan sesquiisostearat PEG-32 Ascorbyl dipalmitate Lauramine oxide Hydrogenated animal glyceride 132

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COSMETIC INGREDIENTS, continued Chemical . ~: r . ~: CAS Number d PEG-7 glyceryl cocoate Cocamidopropylamine oxide TEA-oleamido PEG-2 sulfosuccinate Pareth-45-11 Nonyl nonoxynol-10 phosphate Stearoxytrimethylsilane Solvent yellow 44 Alginic acid DRUGS AND EXCIPIENTS IN DRUG FORMULATIONS 977064-68-8 68155-09-9 Unavailable Unavailable Unavailable Unavailable 0478-20-8 9005-3~-7 * Acetylcysteine616-91-1 Linear tridecyl benzene sulfonateUnavailable * Dichlorophen97-23-4 * Diphenidol hydrochloride3254-89-5 * Lactose63-42-3 Benzalkonium chloride8001-54-5 * Methylergonovine maleate57432-61-8 Flavor aniseUnavailable Chlorphenoxamine hydrochloride562-09-4 * Spironolactone52-01-7 * Norethindrone acetate51-98-9 * Methamphetamine hydrochloride300-42-5 Amylopectin9037-22-3 Flavor mintUnavailable * Phytonadione84-80-0 * Cottonseed oil 8001-29-4 Potassium formate 590-29-4 Polyoxyethylene propylene Unavailable Ethyl vanillin 121-32-4 Triethanolamine polypeptide oleate condensate Unavailable * Amantadine hydrochloride 665-66-7 Sulfoxone sodium 144-75-2 * Carboxypolymethylene 9007-20-9 * Peanut oil 8002-03-7 Insulin suspension, isophane, purified pork Unavailable Bromodiphenhydramine hydrochloride 1808-12-4 * Pyridoxine hydrochloride 58-56-0 Calcium phosphate, tribasic 12167-74-7 * Gelatin 9000-70-8 Promalgen type G Unavailable Mullein leaf Unavailable Sodium chromate, CR-51 10039-53-9 Phenacemide 63-98-9 133

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DRUGS AND EXCIPIENTS IN DRUG FORMULATIONS, continued Chemical CAS Number , . . . . . . Guanidine hydrochloride Orphenadrine hydrochloride Deferoxamine mesylate Cetyl alcohol Clonazepam Testosterone Epinephrine Sennoside A Thyrotropin Opalux AS 8010-A (Black) Ipodate sodium Undecoylium chloride-iodine Flavor sherry, imitation Wax, white Hydrolose Mebutamate Sodium phosphate, monobasic FOOD ADDITIVES Mannose 3,5-Dimethyltetrahydro-1,3,5-thiadiazine 2-thione * * p-Acetamidobenzoic acid Vanadium tetrachloride Ethyl 3-hydroxybutyrate 2,7-Dinitroso-l-naphthol Fennel * Norharman Ionone, gamma Triethylamine hydrochloride Cupric sulfate, anhydrous Ammonium thiocyanate Yeast extract, Baker's Dimethylphenylpiperazinium iodide Sulfide ion Allyl nonanoate Geranium oil Benzyl thiocyanate Polyvinyl ethyl ether Elemene, alpha- Methyl isobutyrate Jasmine absolute 134 50-01-1 341-69-5 70-51-9 124-29-8 1622-61-3 58-22-0 51-43-4 Unavailable 9002-7-5 Unavailable 1221-56-3 1338-54-1 Unavailable 8006-40-4 8012-89-3 9004-64-2 64-55-1 7558-80-7 31103-86-3 533-74-4 556-08-1 7632-51-1 5405-41-4 977014-63-3 977001-13-0 244-63-3 79-76-5 554-68-7 7758-98-7 1762-95-4 8013-01-2 54-77-3 18496-25-8 7493-72-3 8000-46-2 3012-37-1 25104-37-4 5951-67-7 547-63-7 8031-01-4

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FOOD ADDITIVES, continued Chemical , . . . . . CAS Number * Calcium stearate1592-23-0 Pentserythritol tetrakis(3-mercaptopropionate)7575-23-7 Propyl 2-furanacrylate623-22-3 Butter fat977018-87-3 CI Fluorescent Brightener #109 61951-68-6 Soybean mill feed 977030-55-9 Cobalt(2+) caprylate 1588-79-0 Tetramethyl tin 594-27-4 Chromous oxide 12018-00-7 * 1-Monostearin 123-94-4 Asafetida oil 977017-80-3 * Hydrazine hydrate 7803-57-8 DI-Dodecyl tin oxide 22 73-48-5 Molybdic acid 11099-00-6 Celery seed extract Unavailable Diethylene glycol dibenzoate 120-55-8 ~-Menth- 1-en-9-o 1 184 7 9-68-0 * Sodium lauryl sulfate 151-21-3 Guanidoethyl cellulose 9069-21-0 Lipase, animal 977033-78-5 S i 1 icon 7440-21-3 2-Ethylhexyl 9,10-epoxystearate 141-38-8 1,4-Dihydroxy-9,10-anthraquinone 81-64-1 Phytoene 540-04-5 Isoamyl isobutyrate 2050-01-3 2-Tridecanone 593-08-8 _-tert-Butylacrylamide 107-58-4 * Riboflavin supplement 977030-53-7 * Acenaphthylene 208-96-8 Mannide monoleate 25339-93-9 * Di-~2-methoxyethyl) phthalate 117-82-8 * Diethylene glycol 111-46-6 * Linseed oil 8001-26-1 Artichoke leaf Unavailable N-Stearoylsarcosine 142-48-3 - Ethyl 2-methylbutyrate 7452-79-1 Chromium hydroxide 12626-43-6 Xylyl sulfone 27043-27-2 E:-Cymen-8-ol 1197-01-9 Molybdate Orange 12656-85-8 Ammonium isovalerate 7563-33-9 Feculose starch acetate 977033-03-6 Rhynchosia pyramidalis 977030-08-2 Cobalt tallate 61789-52-4 135

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FOOD ADDITIVES, continued Ghemical CAS Number 1 . - 1 1 * Sodium laureth-3 sulfate * Silica Elaidic acid 2-tert-Butyl-4-ethylphenol Allyl isovalerate 1-Methylpiperazine * Calcium saccharin Polyvinyl chloride Isoamyl cinnamate Benzyl phenylacetate Sulfasomidine Butirosin sulfate Guaiaretic acid Soybean hull, ground Norbixin Triethyl lead Propyl phenol Humulus Phthalocyanine Cupric hydroxide Cedarwood oil terpene C.I. Disperse Orange #3 1,4-Dianilinoanthraquinone Dimethylol melamine Tetrakisthydroxymethyl~phosphonium chloride 2-Ethylhexyl mercaptoacetate Pentaerythritol monostearate Itaconic acid-methyl methacrylate copolymer 2,6,6-Trimethyl-2-cyclohexen-1-one Geranial 3,4,5,6-Dibenzacridine Ion-exchange membrane Methyl hydrogen siloxane Valproic acid 13150-00-0 7631-86-9 112-79-8 96-70-8 2835-39-4 109-01-3 6381-91-5 9002-86-2 7779-65-9 102-16-9 [515-64-0] 51022-98-1 500-40-3 977032-85-1 54~-40-5 5224-23-7 31019-46-2 977001-58-3 574-93-6 20427-59-2 68608-32-2 730-40-5 2944-12-9 5001-80-9 124-64-1 7659-86-1 78-23-9 27155-24-4 20013-73-4 141-27-5 ~24-53-3 Unavailable 63148-57-2 99-66-1 CHEMICALS IN COMMERCE Product~on at Least 1 Million Pounds/Year Chemical CAS Number ~ 1 . 7-Oxabicyclo[4~1~0]heptan-2-one' 6-methyl-3 (l-methylethyl) 2-Pyrazolin-5-one, 1-~-aminophenyl)-3-ethoxy Bismuth, compound with gadolinium (1:1) 136 5286-38-4 4105-91-3 12010-44-5

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Production CHEMICALS IN COMMERCE Least 1 Million Pounds/Year, continued Chemical _ C:AS Number Benzene, (2-iodoethyl) Molybdenum phosphide (MoP) D-Glucose, enzyme-hydrolyzed Thiazole, 2-~2-methylpropyl) 1,2-Benzenedicarboxylic acid, bis{2-ethylhexyl) ester, polymer with 1,3 - iisocyanatomethyl benzene, methyloxirane, and 1,2,3-propanetriol Amines, N,N,N'-trimethyl-N'-tallow alkyl= trimethylenedi 2-Propenoic acid, butyl ester, polymer with ethenyl acetate and 2-hydroxyethyl-2-propenoate Poly foxy-1 , 2-ethanediyl), alpha, alPha ' * [(ethyloctadecyliminio)di-2,1-ethanediyl]= bistomega-hydroxy-, ethyl sulfate 1,7-Naphthalenedisulfonic acid, 4-~2,4~ichloro= benzoyl~aminol-5-hydroxy-6-~2-methoxyphenyl) = azo]-, disodium salt Benzenesulfinic acid, 4-chlor~ 1,2-Benzenediamine, _-methyl-, dihydrochloricte Bismuth hydroxide * . . * * * 17376-04-4 12163-69-8 68921-30-2 18640-74-9 68492-79-5 68783-25-5 65776-73-0 42845-62-5 6416-33-7 Ethanol, 2-l(Z-1~2-aminoethyl~aminolethyl)= aminol Phenol, 4,4'- (3H-2,1-benzoxathiol-3-ylidene)= bis(2,5 - imethyl-, S,S -lioxide Benzenethiol, 4 ~odecy1-, hydrogen phosphoro= dithioate, zinc salt Isoguinoline, 1,2,3,4-tetrahydr~ Pentanamicie, N,N~ imethyl 2-Propenamide, N- (hydroxymethyl)-, polymer with 1,3-butadiene and 2-propenenitrile 9H-Fluorene, 2-nitr~ Tannins, salts with 2-~3- (1,3-dihydr~ 1,3,3-trimethyl-2H-indol-2-ylidene)-1-propenyll- 1,3,3-trimethyl-3H-indolium Benzenepropanoic acid, 4-(bist2-(benzoyloxy)= ethYllamino)-alpha~beta~ icYano-, ethY1 ester Silane, (3-isocyanatopropyl) trimethoxy) Benzenesulfonic acid, 3-~(ethoxycarbonyl~aminol-, monosodium salt Hexanedioic acid, polymer with methyloxirane polymer with oxirane ether with oxybis= [propanol ] ~ 2: 1) Octanoic acid, mixed esters with triethylene glycol hexanoate Benzene, 1-iod~ 3 -n itr~ 137 100-03-0 25148-68-9 10361-43-0 1965-29-3 125-31-5 65045-85-4 91-21 - 4 6225-06-5 26603-98-5 607-57-8 68957-25-5 65151-61-3 15396-00-6 71215 -93 -5 63549-52-0 68130-48-3 645-00-1

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CHEMICALS IN COMMERCE Production at Least 1 Million Pounds/Year, continued Chemical CAS Number Calcium hydroxide, reaction products with iron oxide (Fe2O3) and magnesium hydroxide 1-Propanaminium, N-ethyl-N,N-dimethyl-3-~1-oxo= eicosyl~amino]-, ethyl sulfate 8-Oxa-3,5-dithia-4-stannaundecan-1-ol, 4,4-dimethyl-9-oxo-,propanoate PDlytoxy-1,2-ethanediyl), alpha-~2,4-bis= (2-phenyl-1-propenyl~phenyll-omega-hydroxy 2-Naphthalenesulfonic acid, 7-amino-5-~4-~2- bromo-l-oxo-2-propenyl~amino]-2-~4-methyl- 3-sulfophenyl~sulfonyliphenylazo)~-, disodium salt Acetamide, N,N'-1,3-propanediylbis-, N-~3-C20_30-(alkyloxy~propyl] derivatives Benzene, 1,1'-~1,2-ethanediylbis~thio)]bis 2-Naphthalenesulfonic acid, 6-~2,6-dimethylphenyl)= aminol-4-hydroxy 1-Propanamine, 2-chloro-N,N-dimethyl-, hydrochloride Ethanone, 1-~2,4,5-triethoxyphenyl) Acetonitrile, 2,2',2 " ,2 " '_ O_~-h=~^Ai`~= dinitrilo~tetrakis ~, ~ - ~__~ _ * Carbamic acid, (4-chlorophenyl)-, 1-methylethyl ester 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5-phenyl 1-(phenylmethyl) Yttrium oxide sulfate, ytterbiumrdoped Didymium (rare earth mixture) Ethanol, 2,2'-oxybis-, polymer with alPha-hyOr omega-hydroxypolytoxy-1,4-butanediyl) and 1,1'-methylenebisE4-isocyanatobenzene] * Benzene, 1,2,3,5-tetramethyl Phenol, isooctyldinitro 1,3,-Naphthalenedisulfonic acid, 7-~4-~4-~4-aminobenzoyl~aminol-2-methyl= phenyl~azo]-2-methylphenyl~azol-, disodium salt Hexanedioic acid, dimethyl ester, polymer with N,N'-bis(2-aminoethyl)-1,2-ethanediamine and dimethyl pentanedioate Bicycloi3.1.0]hex-2-ene, 2-methyl-5-~1-methylethyl)- 2867-05-2 Benzolalphenoxazin-7-ium, 9-(dimethylamino)-, 966-62-1 chloride Acetic acid, chloro-, 2-phenylethyl ester Antimony phosphiae (SbP) Polyfoxy-1,2-ethanediyl), alPha-hydro-omega-hydroxy-, ether with 2- ~ (2-hydroxyethyl) amino] -2- (hydroxy= methyl) -1 , 3-propanediol ~4: 1) * 68411-13-2 67846-22-4 67905-21-9 72088-88-1 70210-02-5 70528-81-3 622-20-8 23973-67-3 4584-49-0 63213-29-6 5766-67-6 2239-92-1 72846-00-5 68585-88-6 8006-73-3 64078-69-9 527-53-7 37224-61-6 6949-09-3 72175-31-6 138 7476-91-7 25889-81-0 72269-66-0

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CHEMICALS I N COMMERCE Production at Least 1 Million Pounds/Year, continued Chemical CAS Number Iron, complexes with diazotized 2-amino-4, 6-dinitro= phenol monosodium salt coupled with diazotized 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, diazotized 4-amino-3-methylbenzenesulfonic acid, diazotized 4-nitrobenzenamine, and resorcinol Glycerides, tallow di 1,3-Isobenzofurandione, polymer with 1,2-ethane= dial, 2,5-furandione, and 2,2'-oxybisiethanol] 2-Naphthalenesulfonic acid, 5-[bistmethylaulfonyl)= aminol-l-~(methylsulfonyl~oxy]-, sodium salt 2-Butenedioic acid, (E)-, polymer with 1,3-butadiene, ethenylbenzene, (l-methylethenyl~benzene, methyl 2-methyl-2-propenoate, and 2-propenenitrile Phosphonic acid, (1,6-hexanediylbis~nitrilobis= (methylene)~)tetrakis-, hexammonium disodium salt Vanadic acid (H4V2O7), tetracesium salt Cyclohexanone, 2,6-dimethyl-4-~3-methylbutyl) Oxirane, methyl-, polymer with oxirane, mono= (hydrogen sulfate), tridecyl ether Oils, menhaden, polymers with benzoic acid, glycerol, and isophthalic acid Benzenesulfonic acid, 2,5-dichloro 4-~4-~3-~3-~1-~2,5-dichloro-4-sulfophenyl) 4,5-dihydro-5-oxo-1H-pyrazol-4-yliazo~benzoyll= [phenylmethyl~amino)-4-methylphenyl~azo) 4,5-dihydro-5-oxo-1H-pyrazol-l-yll-, disodium salt lH-Purine-2,6,8~3H)-trione, 7,9-dihydro-, calcium salt Vanadium silicide {V3Si) Formaldehyde, polymer with methylphenol and 1,3,5,7-tetraazatricyclo[3.3.1.13~7ldecane Coal, sulfonated 2,5-Hexanediol, 2,5-dimethyl 1~3H)-Isobenzofuranone, 3,3-bist4-(sulfooxy)= phenyll-, dipotassium salt Benzene, 1,2,4-trichloro-3-(chloromethyl) Ethanone, 2-(acetyloxy)-1,2-diphenyl lH-Isoinaol-l-one, 3-amino Poly~difluoromethylene), alpha-hydro-= omega-~(phosphonooxy~methyll PolyLoxy~methyl-1,2-ethanediyl)], alpha-hydro- omega-~3~2-~1-aziridinyl~ethoxy~carbonyl)= amino~methylphenyl~aminolcarbonyl~oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) 139 71662-50-5 68553-08-2 28679-80-3 58596-06-8 69898-51-7 68298-90-8 55343-67-4 71820-43-4 70850-89-4 68458-39-9 71050-54-9 827-37-2 12039-76-8 68845-06-7 69013-20-3 110-03-2 52322-16-4 1424-79-9 574-06-1 14352-51-3 72987-44-1 68015-74-7

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some potentially relevant information. In the latter situation, time constraints precluded review of every document. For this reason, review articles were provided to committee members, who were asked to identify citations that applied to each of the toxicity tests required for a substance's category of intended use. Those primary documents were then collected. When some required toxicity data elements were not uncovered in this way, the data bases were searched again with a focus on the missing elements. EOr this purpose, a list of search terms was developed for each of the major toxicity subjects: carcinogenicity, mutagenicity, reproductive/developmental toxicity, organ and system toxicity, and metabolic effects (toxicokinetics). This procedure eliminated many citations that were not relevant or were already identified. This strategy of data compilation included feedback from committee members after they examined data on a substance. On the basis of their experience, they identified what data might be missing. If the result of a search seemed inappropriate in any way, a followup search was conducted. The greatest difficulty encountered in the use of the powerful searching capabilities of automated files was specific identification of substances that were not clearly defined. Some chemical terms on the list constituting the "select universe" signify materials with uniform compositions, but others describe generic sets of compounds or single compounds that may occur in a variety of physical forms. Still others are chemical mixtures or biologic products that vary in composition from source to source or sample to sample. A few of the chemical names were vague or ambiguous. OTHER SOURCES Textbooks, technical reports, reviews, abstracts, and patent applications provided only limited toxicologic information, but were excellent sources of information on chemical and physical properties, intended uses, and manufacturing processes. To obtain a consistent base of data, a standard search pattern was instituted. One source of information was the computerized toxicity data bases. In addition to abstracts of research papers, abstracts of patent applications were found by computer searches. These often contained information on potential uses. Helpful information was also obtained from the files of the Registry of Toxic Effects of Chemical Substances and from the Toxicology Data Bank. Six reference books were consulted for information on each chemical (Doull et al., 1980; Hawley, 1977; Physicians Desk Reference, 1981; Sollmann, 1957; Weast and Astle, 1979; Windholz et al., 1976~. In addition, other sources were searched for particular types of chemicals (U.S. Environmental Protection Agency, 1980; Estrin et al., 1982; Hayes, 1975; National Research Council, 19811. The nature and extent of the information in these references depend on the uses of a given substance and, hence, are correlated with the listed on which the substance appears. 191

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NRC TOXICOL~Y INFORMATION CENTER ( TIC) Because of the need to gain access both to pre-1965 data and to very recently published data, both of which were not present on computer data bases, the card catalogs of the TIC were searched manually. The 26-yr-old collection of toxicologic information in the TIC includes data produced before the collection began and acquired through retrospective literature searches, in addition to data generated from the establishment of the collection to the present. The TIC is also a repository of reprints gathered for reports of NaC committees, as well as of some private reprint collections donated by toxicologists. Although comprehensive in its collection of information on chemicals encountered environmentally and occupationally, the TIC generally excludes some types of substances, notably drugs and nutrients. GOVERNMENT AGENCY FILES - Some research or regulatory agencies--e.g., the National Institute for Occupational Safety and Health (NIOSH), FDA, EPA, and the Department of Defense (DOD)--have repositories of data on toxicity, manufacturing processes, production volumes, and intended use (including the amounts of substances associated with each type of intended use). Because the committee's intent was not to report the production process and volume data, but rather to use the Data as components of an exposure profile, it asked each agency for permission to gain access to confidential information pertaining to substances in the sample. All the regulatory agencies expressed concern about granting the committee access to trade-secret information provided by industries. In some cases, the agency responses were severely constrained by law, regulation, agency policies, and restrictions imposed by organizations that provided the data. These constraints varied markedly from agency to agency. No criticism of agency responses should be inferred from discussions in the following paragraphs. EPA provided the toxicology portions of pesticide registration applications to NRC staff ano to some committee members not involved in occupations associated with organizations that could benefit from company trade secrets. The information augmented the data in the published literature. Little specific information on extent of environmental contamination was obtained from EPA data files. Because those files are not centralized, it was difficult to gain the required information from them. FDA was reluctant to open files; however, its Bureau of Foods provided access to the SCOGS (Select Committee on GRAS Substances) 192

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reports on substances in the sample. Most of the data in these reports were also identified by other means. The FDA Bureau of Drugs readily provided information on clinical use, route of administration, duration of use, and types of formulations for active drugs, as well as estimates of population exposure to those drugs and adverse reactions to them. Access to information contained in the Bureau of Drugs division reviews, new drug applications (NDAs), investigative new drug (IND) files, and abbreviated new drug applications (ANDAs) was more complex. Regardless of degree of confidentiality, these data were either inaccessible or were made accessible only with great difficulty, because of the excessive costs of manpower required to locate relevant information. There were long delays before the bureau responded to requests from the committee--not because of unwillingness to be responsive, but rather because of acute deficiencies in the bureau's data management. These deficiencies were most apparent after two major requests were made by the committee: The committee asked for a list of currently marketed prescription drugs, over-the-counter drugs, and excipients used in formulations of these drugs. The product was provided 6 months after the request was made, because manpower in the Bureau of Drugs was insufficient and the automated data management systems were incapable of generating the required list readily. The committee asked for toxicity information on chemicals that were sampled from the list eventually provided by the bureau. Within several weeks of the request, some NDAs, ANDAs, INDs, and division reviews were made accessible to cleared NRC staff members, who then had to locate the files and identify pertinent information in them. Most files consisted of many volumes that lacked indexing or content organization, except for chronologic entry of documents. Thus, the search for relevant information required manual scanning of every page in every volume. In many cases, the desired volumes were not available, because they were stored in a warehouse in a manner that made their retrieval extremely difficult or they were lost and could not be traced. Much of the information identified as lost had been submitted to FDA by industries that did not later publish the material. Information collected by NIOSH on some of the substances was organized and readily accessible through that agency's health-hazard evaluations, criteria documents, and Current Intelligence Bulletins. However, these documents contained only a few of the substances of interest to the committee. Toxicity data on several chemicals were found in unclassified documents maintained by NIOSH (National Institute for Occupational Safety and Health, 1982~. 193

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MANUFACTURERS, CO-ED IAL USED, AND T. - DE O~ANI ZATIONS Manufacturers and trade associations are repositories of otherwise unobtainable information on potential occupational exposures, manufacturing processes, waste disposal practices, and production. Their assistance in obtaining information on the 100-substance subsample was requested through the Federal Register on March 16, 1982 (Public Health Service, 1982), and through correspondence with manufacturers of the 40 representative chemicals in commerce selected for the subsample from the TSCA Inventory. Approximately 600 companies were identified in the TSCA Inventory as being manufacturers of at least one of the 40 chemicals in commerce in the subsample. Each company was contacted by telephone, a brief explanation of the project was given, and the information to be sent to them was described. A followup letter--which included a complete description of the project, an alphabetized list of the 100 substances, a request for unpublished toxicity data, and a questionnaire--was sent to each company. The questionnaire contained the following questions: Is the material that is produced in your work environment regulated by FDA, OSHA [the Occupational Safety and Health Administration], EPA, or DOT [Department of Transportation] (and are there guidelines for limiting exposure)? If so, how do you control the chance of exposure? A. By engineering control? B. By personal protective clothing (e.g., the use of respirators)? C. By ventilation (e.g., roof fan, open exhaust)? D. Other (please specify)? Is the material measured in the air? Do you store the material? If so, for how long? Do you run a continuous or batch operation to produce the material? . Mow old is the equipment used to manufacture the material? How frequently is maintenance required on the equipment? Can you indicate how much of this material you produce per year and at what site it is produced? What are the potential uses of this chemical in manufacturing, in commerce, and by consumers? 194

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Some trade associations were contacted directly; others were forwarded the questionnaire by the manufacturers. The Research Institute for Fragrance Materials, the Cosmetic Ingredient Review, the Cosmetic, Toiletry, and Fragrance Association, the American Petroleum Institute, the Soap and Detergent Association, and the Flavor and Extract Manufacturers' Association were some that responded to inquiries. The committee also contacted persons whose professional expertise equipped them to provide additional information on potential human exposure. When information was particularly limited, authors of research papers were contacted in an attempt to obtain more information. Responses to the inquiries were mixed, both in quantity and in usefulness. The few respondents to the Federal Register notice provided much information that was not in the open literature. Approximately 30% of the 600 manufacturers who were contacted responded. Approximately 15% of the 600 stated that they did not manufacture any of the substances. Responses from approximately 3% of the companies indicated that a general willingness to cooperate was frustrated or delayed by resource constraints, lack of expertise, etc. Approximately 5% of the companies supplied answers to the questionnaire, and an additional 5% provided documents and other information on the chemicals of interest. Only 1% of the companies that were contacted responded by indicating that they would not cooperate. Reluctance or inability of industry to cooperate in studies like this was found to be only one factor inhibiting the collection of information on industrial practices and occupational exposure. It is very difficult--often impossible--to locate and contact all the current manufacturers of a given substance. AVAILABILITY AND ROLE OF INFORMATION OTHER THAN TOXICITY DATA Information on intended uses was readily available from the reference textbooks for most cosmetic ingredients, drugs and excipients in drug formulations, and food additives. Similar information on pesticides and inert ingredients of pesticide formulations was more often obtained from computer searches (including patent abstracts), government files, or other special sources. Information on the intended uses of chemicals in commerce (as listed in the TSCA Inventory) was obtained less often from either of these sources than from patent applications and primary literature. Chemical and physical properties were most readily available, although that information was not located for approximately 20% of the substances selected from the TSCA Inventory. Availability of information on manufacturing processes was variable. Even when information on synthesis could be located, several processes were often presented with no indication of which ones were used for bulk production. Limitations of resources did not allow for the case-by-case collection of these data from manufacturers or other sources beyond the collection already described. 195

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Data on the 100 substances in the subsample (chemistry, production and consumption, intended uses, methods of waste and product disposal, and environmental persistence) were considered to be essential for evaluating the adequacy of the toxicity data base. Such data can be used to estimate the number of people potentially exposed, the magnitude and duration of exposure, and the routes of direct and indirect exposure. Without such data, only the most crude and untestable subjective estimates can be made. From the outset, the committee recognized that the desired data on manufacturing processes and environmental persistence would be difficult to obtain, even for high-volume substances. A major limitation was the absence of known data bases in which such information was systematically stored. Furthermore, the data kept in industry files were largely inaccessible or were organized in ways that made it difficult to retrieve pertinent information. If such information were made available, the effort needed to assemble and process it would have added substantially to the workload, and that would have reduced the capacity to acquire and process the toxicity data. Although the task was, at the least, formidable or, more likely, infeasible, an earnest effort was made to address it. Letters sent to known producers requested information on production, occupational exposure, and waste disposal. The responses received contained little usable information. Likewise, requests to government agencies for data on occupational exposure and environmental contamination in general yielded very little specific information on the chemicals of interest. Nominal data had been accumulated by these agencies and not in accessible files. Even the simplest of the relevant data (e.g., reliable annual production rates) could not be obtained in most cases. There were strong indications that three of the 10 subsample substances listed in the TSCA Inventory as having 1977 production of at least 1 million pounds (454 metric tons) were no longer in production or were produced in markedly smaller quantities. As a result, the committee's assessment of the adequacy of the toxicity data on many substances had to be based on sketchy data and subjective estimates of the numbers of persons exposed and the routes, durations, and intensities of their exposure. In most cases, the committee relied solely on information about the products' intended uses, their chemical and physical properties, and the general background knowledge of committee members. The serious weakness of the exposure data base limits the committee's confidence in the adequacy of the toxicity-testing protocols for conducting health-hazard assessments. The lack of suitable exposure data places an even more severe limitation on the application of inferences drawn from analyses of the chemicals in the final sample to the larger "select universe" and on the development of quantitative dose-response models for chemicals in the environment. The assembled toxicity data on the 100 substances provide a good base for examining the predictive nature of toxicity-testing models; however, the absence of exposure data prevents a similar examination of exposure models. 196

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The unavailability of reliable exposure data will be a continuing limitation for NTP in its planning of toxicity testing. NTP would benefit greatly if data of this kind were obtained in cooperation with other federal agencies--such as NIOSH, FDA, EPA, and the Consumer Product Safety Commission--that have an interest in and a need to collect similar information on exposure. REFERENCES , Doull, J., C. D. Klasssen, and M. O. Amdur, Eds. 1980. Casarett and Doull's Toxicology: The Basic Science of Poisons. New York: Macmillan. 778 pp. Estrin, N. F., P. A. Crosley, and C. R. Haynes. 1982. CTFA Cosmetic Ingredient Dictionary, 3rd ed. Washington, D.C.: The Cosmetic, Toiletry and Fragrance Association, Inc. 610 pp. Hawley, G. G., Ed. 1977. The Condensed Chemical Dictionary, 9th ed. New York: Van Nostrand-Reinhold. 957 pp. Hayes, W. J. 1975. Toxicology of Pesticides. Baltimore, Md.: Williams & Wilkins. 580 pp. National Institute for Occupational Safety and Health, Chemical Systems Laboratory. 1982. Subfile excerpted from the NIOSH Registry of Toxic Effects of Chemical Substances. Rockville, Md.: National Institute for Occupational Safety and Health. National Research Council. 1981. Food Chemicals Codex, 3rd ed. Washington, D.C.: National Accademy Press. 735 pp. Physicians Desk Reference. 1981. 35th ed. Oradell, N.J.: Medical Economics Co. 2,047 pp. Public Health Service. 1982. National Toxicology Program. Fed. Reg. 47:11321. Sollmann, T. 1957. A Manual of Pharmacology and Its Applications to Therapeutics and Toxicology, 8th ed. Philadelphia, Pa: W. B. Saunders. 1,535 pp. U.S. Environmental Protection Agency. 1980. Code of Federal Regulations 40. 1980. Subpart D. Exemptions from tolerances, pp. 277-297. In Tolerances and exemptions from tolerances for pesticide chemicals in or on raw agricultural commodities. Section 180.1001. Weast, R. C., and M. J. Astle, eds. 1979. CRC Handbook of Chemistry and Physics, 59th ed. (1978-1979~. West Palm Beach, Fla.: CRC Press. Windholz, J., S. Budavari, L. Y. Stroumtsos, and M. N. Fertig, Eds. 1976. me Merck Index. An Encyclopedia of Chemicals. 9th ed. Rahway, N.J.: Merck & Co. 1,313+ pp. 197

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