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OCR for page 129
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
OCR for page 130
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
OCR for page 131
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
OCR for page 132
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
OCR for page 133
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
OCR for page 134
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
OCR for page 135
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
OCR for page 136
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
OCR for page 137
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
OCR for page 138
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
OCR for page 139
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
OCR for page 188
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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
OCR for page 192
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
OCR for page 193
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
OCR for page 194
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
OCR for page 195
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
OCR for page 196
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
OCR for page 197
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.
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197
OCR for page 198
Representative terms from entire chapter:
commerce production
