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•D -D
C
(O —
CO CO
JJ Ql
CD Q-
^J
4:
* *
[
r
f
<
L
I,
f
I
[
-------
C-20
OSWER Directive 9285.4-1
Date Prepared: October 1. 19S6
EXHIBIT C-3
TOXICITY DATA FOR POTENTIAL CARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY 1J
Oral Route
Inhalation Route
Chemical Name
2-Acetylaminofluorene
Acrylonitrile
Aflatoxin Bl
Aldrin
Amitrole
Arsenic and Compounds
Asbestos
Auramine
Azaserine
Aziridine
Benzene
Benzidine
Benz(a)anthracene
Benz(c)acridine
Benzo(a)pyrene
Benzo(b)fluoranthene
Benzo(k)fluoranthene
Benzotrichloride
Benzyl Chloride
Beryllium and Compounds
Bis(2-chloroethyl)ether
Bis(chloromethyl)ether
Bis(2-ethylhexyl)phthalate (DEHP)
Cacodylic Acid
Cadmium and Compounds
Carbon Tetrachloride
Chlordane
Chloroform
4-Chloro-o-toluidine Hydrochloride
Chromium VI and Compounds
Chrysene
Cyclophosphamide
DDD
DDE
DDT
Diallate
10%
^* f £ ?i r* +• ^' ^ T «
Directive
Dose
(ED10)
mg/kg/day
2.60E-02
4.39E-01
NA
1.52E-02
1.89E-01
7.03E-03
NA
1.08E+00
NA
3.60E-03
3.70E+00
4.50E-04
4.92E-02
6.67E-05
6.28E-03
NA
NA
8.91E-03
NA
NA
8.23E-02
7.22E-04
5.00E+01
NA
NA
1.52E-02
6.61E-02
5.08E-01
8.13E-01
NA
NA
5.70E-02
7.69E-01
2.53E-01
1.79E-01
4.24E-01
Toxicity
Water
(wTc)
1/mg
1.10E+00
6.51E-02
NA
1.88E+00
1.51E-01
4.07E+00
NA
2.66E-02
NA
7.93E+00
7.71E-03
6.34E+01
5.81E-01
4.29E+02
4.55E+00
NA
NA
3.21E+00
NA
NA
3.47E-01
3.96E+01
5.71E-04
NA
NA
1.88E+00
4.32E-01
5.63E-02
3.51E-02
NA
NA
5.01E-01
3.71E-02
1.13E-01
1.59E-01
6.74E-02
Constant
Soil
(sic)
kg/mg
5.50E-05
3.26E-06
NA
9.40E-05
7.56E-06
2.03E-04
NA
1.33E-06
NA
3.97E-04
3.86E-07
3.17E-03
2.91E-05
2.14E-02
2.28E-04
NA
NA
1.60E-04
NA
NA
1.74E-05
1.98E-03
2.86E-08
NA
NA
9.41E-05
2.16E-05
2.81E-06
1.76E-06
NA
NA
2.50E-05
1.86E-06
5.64E-06
7.97E-06
3.37E-06
10%
Effective
Dose
(ED10)
tag/kg/day
2.60E-02
4.39E-01
NA
1.52E-02
1.89E-01
7.03E-03
NA
1.08E+00
NA
3.60E-03
3.70E+00
4.50E-04
4.92E-02
6.67E-05
6.28E-03
NA
NA
8.91E-03
NA
1.25E-02
8.23E-02
7.22E-04
5.00E-K51
NA
1.73E-02
1.52E-02
6.61E-02
5.08E-01
8.13E-01
2.57E-03
NA
5.70E-02
7.69E-01
2.53E-01
1.79E-01
4.24E-01
Air
Toxicity
Constant
(aTc)
(m3/mg)
1.10E+01
6.51E-01
NA
1.88E+01
1.51E+00
4.07E+01
NA
2.66E-01
NA
7.93E+01
7.71E-02
6.34E+02
5.81E+00
4.29E+03
4.55E-MD1
NA
NA
3.21E+01
NA
2.28E+01
3.47E+00
3.96E+02
5.71E-03
NA
1.65E+01
1.88E+01
4.32E+00
5.63E-01
3.51E-01
1.11E+02
NA
5.01E+00
3.71E-01
1.13E+00
. 1.59E+00
6.74E-01
* *
October 1986 * * *
-------
C-21
OSWER Directive 9285.4-1
Date Prepared: October 1. 1986
EXHIBIT C-3
(Continued)
TOXICITY DATA FOR POTENTIAL CARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Oral Route
Inhalation Route
Chemical Name
Diaminotoluene (mixed)
1,2,7,8-Dibenzopyrene
Diberiz (a, h) anthracene
l,2-Dibromo-3-chloropropane "'
Dibutylnitrosamine
3,3'-Dichlorobenzidine
1,2-Dichloroethane (EDC)
1,1-Dichloroethylene
Dichloromethane
Dieldrin
Diepoxybutane
Diethanolnitrosamine
Diethyl Arsine
1,2-Diethylhydrazine
Diethylnitrosamine
Diethylstilbestrol (DES)
Dihydrosafrole
3,3'-Dimethoxybenzidine
Dimethyl Sulfate
Dimethylaminoazobenzene
7,12-Dimethylbenz(a)anthracene
3,3'-DimethyIbenzidene
Dimethylcarbamoyl Chloride
1,1-Dimethylhydrazine
1,2-Dimethylhydrazine
DimethyInitrosamine
Dinitrotoluene (mixed)
2,4-Dinitrotoluene
2,6-Dinitrotoluene
1,4-Dioxane
1,2-Diphenylhydrazine
Dipropylnitrosamine
Epichlorohydrin
Ethyl-4,4*-dichlorobenzilate
Ethylene Dibromide (EDB)
Ethylene Oxide
10%
Effective
Dose
(ED10)
mg/kg/day
3.40E-01
NA
2.83E-03
6.00E-03
2.29E-02
1.20E-01
4.88E-01
2.33E-01
NA
7.81E-03
3.58E-02
NA
NA
NA
1.03E-03
2.11E-04
9.26E-01
2.00E+01
NA
9.52E-03
5.23E-06
3.70E-02
1.98E-03
7.44E-02
1.87E-04
3.91E-02
2.62E-01
2.62E-01
NA
2.94E+01
2.19E-01
NA
2.70E+00
5.59E-01
2.56E-03
4.13E-01
Toxicity Constant
Water
(wTc)
I/rag
8.40E-02
NA
1.01E+01
4.76E+00
1.25E+00
2.39E-01
5.86E-02
1.23E-01
• NA
3.66E+00
7.98E-01
NA
NA
NA
2.77E+01
1.35E+02
3.09E-02
1.43E-03
NA
3.00E+00
5.46E+03
7.71E-01
1.44E+01
3.84E-01
1.53E+02
7.30E-01
1/09E-01
1.09E-01
NA
9.71E-04
1.31E-01
NA
1.06E-02
5.11E-02
1.11E+01
6.91E-02
Soil
(sic)
kg/mg
4.20E-06
NA
5.04E-04
2.38E-04
6.24E-05
1.19E-05
2.93E-06
6.14E-06
NA
1.83E-04
3.99E-05
NA
NA
NA
1.38E-03
6.77E-03
1.54E-06
7.14E-08
NA
1.50E-04
2.73E-01
3.86E-05
7.22E-04
1.92E-05
7.65E-03
3.65E-05
5.46E-06
5.46E-06
NA
4.86E-08
6.53E-06
NA
5.29E-07
2.56E-06
5.57E-04
3.46E-06
10%
Effective
Dose
(ED10)
rag/ kg/ day
3.40E-01
NA
2.83E-03
6.00E-03
2.29E-02
1.20E-01
4.88E-01
2.33E-01
NA
7.81E-03
3.58E-02
NA
NA
NA
1.03E-03
2.11E-04
9.26E-01
2.00E+01
NA
9.52E-03
5.23E-06
3.70E-02
1.98E-03
7.44E-02
1.87E-04
3.91E-02
2.62E-01
2.62E-01
NA
2.94E+01
2.19E-01
NA
2.70E+00
5.59E-01
2.56E-03
4.13E-01
Air
Toxicity
Constant
UTc)
m3/mg
8.40E-01
NA
1.01E+02
4.76E+01
1.25E+01
2.39E+00
5.86E-01
1.23E+00
NA
3.66E+01
7.98E+00
NA
NA
NA
2.77E+02
1.35E+03
3.09E-01
1.43E-02
NA
3.00E+01
5 . 46E+04
7.72E+00
1.44E+02
3 . 84E+00
1.53E+03
7.30E+00
1.09E+00
1.09E+00
NA
9.71E-03
1.31E4-00
NA
1.06E-01
5.11E-01
1.11E+02
6.91E-01
* *
October 1986
-------
C-22
OSWER Directive 9285.4-1
Date Prepared: October 1, 1986
EXHIBIT C-3
(Continued)
TOXICITY DATA FOR POTENTIAL CARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Oral Route
Inhalation Route
Chemical Name
Ethylenethiourea
Ethyl Methanesulfonate
1-Ethyl-nitrosourea
Formaldehyde
Glycidaldehyde
Heptachlor
Heptachlor Epoxide
Hexachlorobenzene
Hexachlorobutadiene
alpha-Hexachlorocyclohexane (HCCH)
beta-HCCH
gamma-HCCH (Lindane)
Hexachloroethane
Hydrazine
Indeno(l,2,3-cd)pyrene
lodomethane
Isosafrole
Kepone
Lasiocarpine
Melphalan
Methyl Chloride
3-Methylcholanthrene
4,4'-Methylene-bis-2-chloroaniline
Methylnitrosourea
Methylnitrosourethane
Methylthiouracil
Methylvinylnitrosamine
N-Methyl-N1-nitro-N-nitrosoguanadine
Mitomycin C
1-Napthylamine
2-Napthylamine
Nickel and Compounds
N-Nitrosopiperidine
N-Nitrosopyrrolidine
5-Nitro-o-toluidine
Pentachloronitrobenzene
10?.
T?ffr***^4\m
LireCLive
Dose
(ED10)
mg/kg/day
7.69E-01
5.58E-03
1.14E-01
4.90E-02
3.45E-01
8.93E-03
3.45E-03
" 8.51E-02
1.69E+00
1.83E-02
5.75E-01
5.46E-01
1.25E+01
1.27E-02
NA
NA
1.67E+00
2.09E-02
2.66E-02
9.09E-04
1.05E+01
4.64E-02
8.20E-01
9.48E-05
NA
3.50E-02
NA
le 1.79E-02
NA
NA
1.98E-01
NA
3.88E-02
5.36E-03
7 . 14E+00
7.04E-01
Toxicity
Water
(wTc)
1/mg
3.71E-02
5.12E+00
2.50E-01
5.83E-01
8.29E-02
3.20E+00
8.28E+00
3.36E-01
1.69E-02
1.56E+00
4.97E-02
5.23E-02
2.29E-03
2.25E+00
NA
NA
1.71E-02
1.37E+00
1.08E+00
3.14E+01
2.71E-03
6.16E-01
3.49E-02
3.01E+02
NA
8.16E-01
NA
1.59E+00
NA
NA
1.44E-01
NA
7.37E-01
5.33E+00
4.00E-03
4.06E-02
Constant
Soil
(sic)
kg/mg
1.86E-06
2.56E-04
1.25E-05
2.92E-05
4.14E-06
1.60E-04
4.14E-04
1.68E-05
8.43E-07
7.79E-05
2.49E-06
2.61E-06
1.14E-07
1.13E-04
NA
NA
8.57E-07
6.85E-05
5.38E-05
1.57E-03
1.36E-07
3.08E-05
1.74E-06
1.51E-02
NA
4.08E-05
NA
7.97E-05
NA
NA
7.21E-06
NA
3.68E-05
2.66E-04
2.00E-07
2.03E-06
IQ%
E r zect ive
Dose
(ED10)
rag/kg/day
7.69E-01
5.58E-03
1.14E-01
4.90E-02
3.45E-01
8.93E-03
3.45E-03
8.51E-02
1.69E+00
1.83E-02
5.75E-01
5.46E-01
1.25E+01
1.27E-02
NA
NA
1.67E+00
2.09E-02
2.66E-02
9.09E-04
1.05E+01
4.64E-02
8.20E-01
9.48E-05
•NA
3.50E-02
NA
1.79E-02
NA
NA
1.98E-01
l.OOE-01
3.88E-02
5.36E-03
7 . 14E+00
7.04E-01
Air
rp/-.v 4 r* 4 f \r
1 oxxc ity
Constant
(aTc)
m3/mg
3.71E-01
5.12E+01
2.50E+00
5.83E+00
8.29E-01
3.20E+01
8.28E+01
3.36E+00
1.69E-01
1.56E+01
4.97E-01
5.23E-01
2.29E-02
2.25E+01
NA
NA'
1.71E-01
1.37E+01
1.08E+01
3.14E+02
2.71E-02
6.16E+00
3.49E-01
3.01E+03
NA
8.16E+00
NA
1.59E-HD1
NA
NA
1.44E+00
2.85E+00
7.37E+00
5.33E+01
4.00E-02
4.06E-01
October 1986
-------
C-23
OStfER Directive 9285.4-1
Date Prepared: October 1, 1986
EXHIBIT C-3
(Continued)
TOXICITY DATA FOR POTENTIAL CARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Chemical Name
Pentachlorophenol
Phenacetin
Polychlorinated Biphenyls (PCBs)
Polynuclear Aromatic Hydrocarbons
Propane Sultone
1,2-Propylenimine
Saccharin
Safrole
Streptozocin
2,3,7,8-TCDD -(Dioxin)
1,1,1,2-Tetrachloroethane
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
Thioacetaraide
Thiourea
o-Toluidine hydrochloride
Toxaphene
1,1,2-Trichloroethane
Trichloroethylene
2,A,6-Trichloropheno1
Tris(2,3-dibromopropyl)phosphate
Trypan Blue
Uracil Mustard
Urethane
Vinyl Chloride
Oral Route
Inhalation Route
10%
Effective
Dose
(ED10)
nig/kg/day
NA
1.25E+01
5.00E-02
NA
2.85E-02
3.35E-02
2.44E+02
5.00E+00
9.17E-03
8.33E-06
1.20E+00
6.02E-01
3.23E+00
4.04E-02
9.52E-01
6.37E-01
1.02E-01
2.7SE+00
6.67E+00
1.25E+01
1.02E-01
2.78E+00
NA
1.56E+00
6.67E+00
Toxicity C
Water
(wTc)
1/mg
NA
2.29E-03
5.71E-01
NA
l.OOE+00
8.53E-01
1.17E-04
5.71E-03
3.12E+00
3.43E+03
2.37E-02
4.74E-02
8.86E-03
7.07E-01
3.00E-02
4.49E-02
2.80E-01
1.03E-02
4.29E-03
2.29E-03
2.79E-01
1.03E-02
NA
1.83E-02
4.29E-03
onstant
Soil
(sic)
kg/mg
NA
1.14E-07
2.86E-05
NA
5.01E-05
4.27E-05
5.86E-09
2.86E-07
1.56E-04
1.71E-01
1.19E-06
2.37E-06
4.43E-07
3.54E-05
1.50E-06
2.24E-06
1.40E-05
5.14E-07
2.14E-07
1.14E-07
1.39E-05
5.14E-07
NA
9.14E-07
2.14E-07
10%
Effective
Dose
(ED10)
mg/kg/day
NA
1.25E+01
5.00E-02
NA
2.85E-02
3.35E-02
2.44E+02
5 . OOE+00
9.17E-03
8.33E-06
1.20E+00
6.02E-01
3.23E+00
4.04E-02
9.52E-01
6.37E-01
1.02E-01
2.78E+00
6.67E+00
1.25E+01
1.02E-01
2.78E+OQ
NA
1.56E-KX)
6.67E+00
Air
T^ V T f* 4 +• ^T
loxicity
Constant
(aTc)
m3/mg
NA
2.29E-02
5.71E+00
NA
l.OOE+01
8.53E+00
1.17E-03
5.71E-02
3.12E+01
3.43E+04
2.37E-01
4.74E-01 •
8.86E-02
7.07E+00
3.00E-01
4.49E-01
2.80E+00
1.03E-01
4.29E-02
2.29E-02
2.79E+00
1.03E-01
NA
1.83E-01
4.29E-02
1J The list of chemicals presented in this exhibit is based on EPA's Reportable
Quantities Analysis and should not be considered an all-inclusive list of suspected
carcinogens. Refer to Exhibit C-4 for toxicity data for risk characterization for the
chemicals listed here.
* *
October 1986
-------
C-24
OSWER Directive 9285.4-1
Date Prepared: October 1. 1966
EXHIBIT C-4
TOXICITY DATA FOR POTENTIAL CARCINOGENIC EFFECTS
-- RISK CHARACTERIZATION l-
Oral Route
Inhalation Route
Chemical Name
2-Acetylaminofluorene
Acrylonitrile
Aflatoxin Bl
Aldrin
Amitrole
Arsenic and Compounds
Asbestos
Auramine
Azaserine
Aziridine
Benzene
Benzidine
Benz(a)anthracene
Benz(c)acridine
Benzo(a)pyrene ; ' .
Benzo(b)fluoranthene
Benzo(k)fluoranthene
Benzotrichloride
Benzyl Chloride
Beryllium and Compounds
Bis(2-chloroethyl)ether
Bis(chloromethyl)ether
Bis(2-ethylhexyl)phthalate (DEHP)
Cacodylic Acid
Cadmium and Compounds
Carbon Tetrachloride
Chlordane
Chloroform
4-Chloro-o-toluidine Hydrochloride
Chromium VI and Compounds
Chrysene
Cyclophosphamide
ODD
DDE
DDT
Potency EPA
Factor Weight
(PF) of
(mg/kg/d)-l Source2- Evidence
Potency EPA
Factor Weight
(PF) of
(mg/kg/d)-l Source2- Evidence
2
1
1
5
1
1
6
1
.1
8
3
.90E+03
.14E+01
.50E+01
.20E-02
. 15E+01
NA
. 10E+00
.84E-04
NA
.30E-01
.61E+00
.10E-02
NA
.40E-01
CAG
CAG
HEA
HEA
HEA
CAG
CAG
HEA
HEA
HEA
HEA
B2
Bl 2.40E-01 CAG
B2
B2
B2
A 5.00E+01 HEA
A
B2
B2
62
A 2.60E-02 HEA
A 2.30E+02 CAG
B2
C
B2 6.10E+00 HEA
B2
D
B2
C
Bl 4.86E+00 CAG
B2
A 9 . 30E+03 CAG
B2
D
6.10E+00 HEA
B2
B2
B2
B2
4.10E+01 HEA
B2
Bl
B2
B2
B2
B2
Bl
B2
B2
B2
A
A
B2
B2
B2
A
A
B2
C
B2
B2
D
B2
C
Bl
B2
A
B2
D
Bl
B2
B2
B2
B2
A
B2
Bl
B2
B2
B2
* * * October 1986 * * *
-------
Directive 9285.4-1
C-25
Dace Preoared: October 1. 19S6
EXHIBIT C-4
(Continued)
TOXICITY DATA FOR POTENTIAL CARCINOGENIC EFFECTS
-- RISK CHARACTERIZATION
Oral Route
Inhalation Route
Chemical Name
Diallate
Diaminotoluene (mixed)
1,2,7,8-Dibenzopyrene
Dibenz(a,h)anthracene
1,2-Dibromo-3-chloropropane
Dibutylnitrosamine
3,3'-Dichlorobenzidine
1,2-Dichloroethane (EDC)
1,1-Dichloroethylene
Dichloromethane
Dieldrin
Diepoxybutane
Diethanolnitrosamine
Diethyl Arsine
1,2-Diethylhydrazine
Diethylnitrosamine
Diethylstilbestrol (DES)
Dihydrosafrole
3,3' -Dimetho.xybenzidine
Dimethyl Sulfate
Dimethylaminoazobenzene
7,12-Dimethylbenz(a)anthracene
3,3'-Dimethylbenzidene
Dimethylcarbamoyl Chloride
1,1-DimethyIhydrazine
1,2-Dimethylhydrazine
Diraethylnitrosamine
Dinitrotoluene (mixed)
2,4-Dinitrotoluene
2,6-Dinitrotoluene
1,4-Dioxane
1,2-Diphenylhydrazine
Dipropylnitrosamine
Epichlorohydrin
Ethyl-4,4'-dichlorobenzilate
Ethylene Dibromide (EDB)
Potency EPA Potency EPA
Factor Weight Factor Weight
(PF) of (PF) of
(mg/kg/d)-l Source2- Evidence (mg/kg/d)-l Source2- Evidence
5
1
9
5
7
3
4
2
3
7
9
4
.40E+00
.70E+00
.10E-02
.80E-01
.50E-03 '
.OOE+01
.40E+01
.60E+01
.10E-01
.70E-01
.90E-04
.10E+01
CAG
CAG
HEA
HEA
HEA
CAG
CAG
CAG
CAG
CAG
CAG
CAG
C
B2
B2
B2
B2
B2
B2
B2 3.50E-02 HEA
C 1.16E+00 HEA
• B2 1.43E-02 HEA .
B2
B2
B2
D
B2
B2
A
B2
B2
B2
B2
B2
B2
B2
B2
B2
B2
B2
B2
C
B2
Bl
B2
B2
B2
B2
B2
B2
B2
B2
B2
B2
B2
B2
C
B2
B2
B2
B2
D
B2
B2
A
B2
B2
B2
B2
B2
B2
B2
B2
B2
B2
B2
B2
C
B2
B2
B2
B2
B2
B2
* * * October 1986 * * *
-------
Directive 9285.4-
C-26
Dare Prepared: October 1. 195c
:\
r
, EXHIBIT C-4
(Continued)
TOXICITY DATA FOR POTENTIAL CARCINOGENIC EFFECTS
-- RISK CHARACTERIZATION
Oral Route
Inhalation Route
Chemical Name
Ethylene Oxide
Ethylenethiourea
Ethyl Methanesulfonate
1-Ethyl-nitrosourea
Formaldehyde
Glycidaldehyde
Heptachlor
Heptachlor Epoxide
Hexachlorobenzene
Hexachlorobutadiene
alpha-Hexachlorocyclohexane (HCCH)
beta-HCCH
gamma-HCCH (Lindane)
Hexachloroethane
Hydrazine
Indeno(l,2,3-cd)pyrene
lodomethane
Isosafrole
Kepone
Lasiocarpine
Melphalan
Methyl Chloride
3-Methylcholanthrene
4,4'-Methylene-bis-2-chloroaniline
Methylnitrosourea
Methylnitrosourethane
Methylthiouracil
Methylvinylnitrosamine
N-Methyl-N'-nitro-N-nitrosoguanadine
Mitomycin C
1-Napthylamine
2-Napthylamine
Nickel and Compounds
N-Nitrosopiperidine
N-Nitrosopyrrolidine
5-Nitro-o-toluidine
Potency EPA
Factor Weight
(PF) of
(mg/kg/d)-l Source2-1 Evidence
Potency EPA
Factor Weight
(PF) of
(mg/kg/d)-l Source2-' Evidence
3
3
2
1
7
1
1
1
1
3
.e
2
.30E+01
.40E+00
.60E+00
.69E+00
.75E-03
.10E+01
.SOE+00
.33E+00
.40E-02
.OOE+02
N'A
. 10E+00
CAG
CAG
CAG
HEA
HEA
CAG
CAG
HEA
CAG
CAG
CAG
B1/B2 3.50E-01 CAG
B2
B2
B2
B2
B2
B2
B2
B2
C
B2
C
B2/C
C
B2
C
C
B2
B2
B2
Bl
C
B2
B2
B2
B2
B2
B2
B2
B2
C
A
A 1 . 19E+00 HEA
B2
B2
C
B1/B2
B2
B2
B2
B2
B2
B2
B2
B2
C
B2
C
B2/C
C
B2
C
C
C
B2
B2
Bl
C
B2
B2
B2
B2
B2
B2
B2
B2
C
A
A
B2
B2
C
* * * October 1986 * * *
-------
c-2;
OSVER Directive 9285.4-1
Date Prepared: October 1. 195o
EXHIBIT C-4
(Continued)
TOXICITY DATA FOR POTENTIAL CARCINOGENIC EFFECTS
-- RISK CHARACTERIZATION
Chemical Name
Pentachloronitrobenzene
Pentachlorophenol
Phenacetin
Polychlorinated Biphenyls (PCBs)
Polynuclear Aromatic Hydrocarbons
Propane Sultone
1,2-Propylenimine
Saccharin
Safrole
Streptozocin
2,3,7,8-TCDD (Dioxin)
1,1,1,2-Tetrachloroethane
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
Thioacetamide
Thiourea
o-Toluidine hydrochloride
Toxaphene
1,1,2-Trichloroethane
Trichloroethylene
2,4,6-Trichlorophenol
Tris(2,3-dibromopropy1)phosphate
Trypan Blue
Uracil Mustard
Urethane
Vinyl Chloride
Oral Route
Inhalation Route
Potency EPA
Factor Weight
(PF) of
(mg/kg/d)-l Source2-1 Evidence
Potency EPA
Factor Weight
(PF) of
(mg/kg/d)-l Source2-' Evidence
4
1
1
2
5
1
5
1
1
2
. 34E+00
.15E+01
.56E+05
.OOE-01
.10E-02
. 10E+00
.73E-02
.10E-02
.98E-02
.30E+00
HEA
HEA
HEA
HEA
HEA
CAG
HEA
HEA
HEA
HEA
C
D
B2
B2
6.11E+00 HEA
B2
B2
C
B2
B2
B2
B2'
C
B2 1.70E-03 HEA
B2
B2
B2
B2
C
B2 4.60E-03 HEA
B2
B2
B2
B2
B2
A 2.50E-02 HEA
r-
^
D
B2
B2
B2
B2
C
B2
B2
B2
C
C
B2
B2
B2
B2
B2
C
B2
B2
B2
B2
B2
B2
A
1J The list of chemicals presented in this exhibit is based on EPA's Reportable Quantities
Analysis and should not be considered an all-inclusive list or suspected carcinogens. Refer
to Exhibit C-3 for toxicity constants for indicator selection for the chemical's listed here.
2J Sources for Exhibit C-4:
HEA = Health Effects Assessment, prepared by the Environmental Criteria and
Assessment Office, U.S. EPA, Cincinnati, Ohio, 1985 (updated in May 1986).
CAG = Evaluation by Carcinogen Assessment Group, U.S. EPA, Washington, D.C., 1985.
* * October 1986 * * *
-------
Directive 9285.4-1
C-28
Date Prepared: October 1. 1986
EXHIBIT C-5
TOXICITY DATA FOR NONCARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY '-'
Oral Route
Inhalation Route
Chemical Name
" Acenaphthene @
Acenaphthylene @
Acetone
Acetonitrile
2-Acetylaminofluorene @
Acrylic Acid
Acrylonitrile @
Aflatoxin Bl @
Aldicarb
Aldrin @
Allyl Alcohol
Aluminum Phosphide
4-Aminobiphenyl @
Amitrole @
Ammonia
Anthracene @
Antimony and Compounds
Arsenic and Compounds @
Asbestos @
Auramine @
Azaserine @
Aziridine (§
Barium and Compounds
Benefin
Benzene @
Benzidine @
Benz(a)anthracene @
Benz(c)acridine @
Benzo(a)pyrene (§
Benzo(b)fluoranthene @
Benzo(ghi)perylene (§
Benzo(k)fluoranthene @
Benzotrichloride @
Benzyl Chloride @
Beryllium and Compounds @
1,1-Biphenyl
Bis(2-chloroethyl)ether @
Bis(2-chloroisopropyl)ether
Bis(chloromethyl)ether (§
Bis(2-ethylhexyl)phthalate (DEHP)
Bromomethane
Minimum
Effect i ve
Dose
(MED)
mg/day
2.99E+01
3.54E+00 *
8.80E-01
4.60E+00
1 . OOE+00
4.90E+00
8.55E+01
2.24E+01
Toxicity
Water
(win)
RVe 1/mg
9 6.02E-01
6 3.39E+00
3 6.82E+00
10 4.35E+00
9 1.80E+01
10 4.08E+00
5 1.17E-01
8 7.14E-01
Constant
Soil
(sin)
kg/mg
3.01E-05
1.69E-04
3.41E-04
2.17E-04
9.00E-04
2.04E-04
5.85E-06
3.57E-05
Minimum
Effective
. Dose
(MED)
mg/day
1 . 23E+02
4.34E+01
3.54E+00
4.25E+01
7.00E-01
1. OOE+00 *
2.70E-02
4.90E+00 *
1 . 70E+00
1.19E+01
RVe
8
10
6
5
8
9
10
10
10
7
Air
Toxicity
Constant
(aTn)
m3/kg
1.31E+00
4.61E+00
3.39E+01
2.35E+00
2.29E+02
1.80E+02
7.41E+03
4.08E+01
1.18E+02
1.18E+01
6.00E-01
8 2.67E+01 1.33E-03 6.28E+00
1.10E-02
1.91E+01
8 1.45E+04
7.43E+02 10 2.69E-02 1.35E-06 7.43E+02 * 10 2.69E-01
* * * October 1986 * * *
-------
OSWER Directive 9285.4-1
C-29
Date Prepared: Octobe
r 1. 19S6 |
EXHIBIT C-5
(Continued)
TOXICITY DATA FOR NONCARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Oral Route
Inhalation Route
Chemical Name
Bromoxynil Octanoate
1,3-Butadiene
n-Butanol
Butylphthalyl Butylglycolate
Cacodylic Acid @
Cadmium and Compounds (2
Captan
Carbaryl
Carbon Disulfide
Carbon Tetrachloride @
Chlordane @
Chlorobenzene
Chlorobenzilate @
Chlorodibromomethane
Chloroform @
Chloromethyl Methyl Ether @
4-Chloro-o-toluidine Hydrochloride@
Chromium III and Compounds
Chromium VI and Compounds @
Chrysene (?
Copper and Compounds
Creosote @
Cresol
Crotonaldehyde
Cyanides (n.o.s.) 2J
-- Barium Cyanide
-- Calcium Cyanide
-- Cyanogen
-- Cyanogen Chloride
-- Copper Cyanide
-- Hydrogen Cyanide
-- Nickel Cyanide
-- Potassium Cyanide
-- Potassium Silver Cyanide
-- Silver Cyanide
-- Sodium Cyanide
-- Zinc Cyanide
Cyclophosphamide (§
Dalapon
ODD <§
Minimum Toxicity Constant
r £ £
Dose Water Soil
(MED) . . (win) (sin)
rag/day RVe 1/mg kg/mg
2.39E+00 4 3.35E+00 1.67E-04
4.49E+00 10 4.45E+00 2.23E-04
9.85E+02 10 2.03E-02 1.02E-06
3.30E+01 * 7 4-.24E-01 2.12E-05
6.30E+01 * 10 3.17E-01 1.59E-05
5.60E+01 4 1.43E-01 7.14E-06
6.60E+00 6 1.82E+00 9.09E-05
1.40E+01 5 7.14E-01 3.57E-05
1.34E+00 * 4 5.97E+00 2.99E-04
Minimum
r* £ £ «• •
tti reci ive
Dose
(MED)
rag/day RVe
2.39E+00 * 4
4.46E-01 8
9.85E+02 * 10
3.30E+01 7
6.30E+01 10
7.18E+01 1
6.60E+00 * 6
5 . 90E+00 7
6.40E+00 8
1.40E+01 * 5
1 . 34E+00 4
Air |
T V
ioxicity M
Constant
(aTn)
m3/kg F
<
3.35E+01 F
l
1
3.59E+02 |
2.03E-01 A
1
4.24E+00
3.17E+00 I
I
2.79E-01
1.62E+01 fj
1:
2.37E+01
r
t
2.50E-r01 *•
7.14E+00 I<
f
5.97E+01
•-
1
L
(
.
|
^-
\
[
w*
r
V
t
1,
* * * October 1986 * * *
(
-------
C-30
Directive ^285.4-1
Date Prepared: October 1, 19So
EXHIBIT C-5
(Continued)
TOXICITY DATA FOR NONCARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Oral Route
Chemical Name
DDE @
DDT @
Decabromodiphenyl Ether
Diallate @
2,4-Diaminotoluene @
1,2,7,8-Dibenzopyrene @
Dibenz(a,h)anthracene @
1,2-Dibromo-3-chloropropane (3
Dibutylnitrosamine @
Dibutyl Phthalate
1,2-Dichlorobenzene
1,3-Dichlorobenzene
1,4-Dichlorobenzene
3,3'-Dichlorobenzidine @
Dichlorodifluoromethane
1,1-Dichloroethane
1,2-Dichloroethane (EDC) @
1,1-Dichloroethylene @
1,2-Dichloroethylene (cis)
1,2-Dichloroethylene (trans)
Dichloromethane (§
2,4-Dichlorophenol
2,4-Dichlorophenoxyacetic
Acid (2,4-D)
4-(2,4-Dichlorophenoxy)butyric
Acid (2,4-DB)
Dichlorophenylarsine @
1,2-Dichloropropane
1,3-Dichloropropene
Dieldrin @
Diepoxybutane @
Diethanolnitrosamine @
Diethyl Arsine @
1,2-Diethylhydrazine @
Diethylnitrosamine @
Diethyl Phthalate
Diethylstilbestrol (DES) @
Dihydrosafrole (3
Dimethoate
3,3'-Dimethoxybenzidine <§
Inhalation Route
Minimum
Effective
Dose
(MED)
mg/day
Toxicitv Constant
RVe
Water
(win)
1/mg
Soil
(sTn)
kg/mg
Minimum
Effective
Dose
(MED)
mg/day
Air
Toxicitv
Constant
(aTn)
RVe m3/kg
4
1
1
1
5
1
3
1
1
2
1
1
2
6
.20E+02
.54E+02
.54E+02
.54E+02
.42E+02 *
. 14E+03
.77E+01
.89E+02 *
.89E+02 *
. 18E+04
.21E+02
.29E+02
.OOE+02 *
.OOE-01
8
4
4
4
7
10
7
5
5
10
5
8
10
1
3.
5.
5.
5.
2.
1.
3.
5.
5 .
9.
8.
1.
1.
3.
81E-02
19E-02
19E-02
19E-02
58E-02
76E-02
71E-01
29E-02
29E-02
20E-04
26E-02
24E-01
OOE-01
33E+00
1
2
2
2
1
8
I
2
2
4
4
6
5
1
.90E-06
.60E-06
.60E-06
.60E-06
.29E-06
.80E-07
.86E-05
.65E-06
.65E-06
.60E-08
.13E-06
.20E-06
.OOE-06
.67E-04
4.
2.
2.
2.
5.
1.
1.
1.
1.
2.
1.
1.
2.
3.
20E+02 *
77E+02 *
77E+02
77E+02
42E+02
45E+02
77E+01
89E-I-02
89E+02
18E+04 *
21E+02 *
29E+02 *
OOE+02
24E+00
8
5
5
5
7
8
5
5
5
10
5
8
10
5
3
3
3
3
2
1
5
5
5
9
8
1
1
3
.81E-01
.61E-01
-61E-01
.61E-01
.58E-01
.10E+00
.65E+00
.29E-01
.29E-01
.20E-03
.26E-01
.24E+00
.OOE+00
.09E+01
2.99E+04
2.67E-04 1.34E-08 2.99E+04 * 4 2.67E-03
* * * October 1986 * * *
-------
OSWER Directive 9285.4-1
C-31
Date Prepared: October 1. 1986
EXHIBIT C-5
(Continued)
TOXICITY DATA FOR NONCARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Oral Route
Inhalation Route
Chemical Name
Dimethylaraine
Dimethyl Sulfate (3
Dimethyl Terephthalate
Dimethylaminoazobenzene @
7,12-Dimethylbenz(a)anthracene (?
3,3' -Dimethylbenzidine (§
Dimethylcarbamoyl Chloride @
1,1-Dimethylhydrazine @
1,2-Dimethylhydrazine @
Dimethylnitrosamine @
1,3-Dinitrobenzene
4,6-Dinitro-o-cresol
2,4-Dinitrophenol
2,3-Dinitrotoluene @
2,4-Dinitrotoluene (3
2,5-Dinitrotoluene @
2,6-Dinitrotoluene @
3,4-Dinitrotoluene @
Dinoseb
1,4-Dioxane (2
N,N-Diphenylamine @
1,2-Diphenylhydrazine @
Dipropylnitrosamine (§
Disulfoton
Endosulfan
Epichlorohydrin @
Ethanol
Ethyl Acetate
Ethyl Methanesulfonate @
Ethylbenzene
Ethyl-4,4'-dichlorobenzilate @
Ethylene Dibromide (EDB) (§
Ethylene Oxide (3
Ethylenethiourea @
1-Ethyl-nitrosourea @
Ethylphthalyl Ethyl Glycolate
Ferric Dextran (§
Fluoranthene @
Fluorene @
Fluorides
Minimum
Effective
Dose
(MED)
nig/day
Toxicity Constant
RVe
Water
(win)
1/mg
Soil
(sin)
kg/mg
Minimum
Effective
Dose
(MED)
mg/day
RVe
Air 1
Toxicity|
Constant
(aTn) ,
m3/kg I
3.70E+01 * 6 3.24E-01 1.62E-05 3.70E+01
3.24E+00 '
1
1.35E-t-00
2.45E+00
1.40E+01
2.05E+01
2.99E+01
6
8
8
9
9
8.89E+00 4.44E-04
6.53E+00 3.27E-04
1.14E+00 5.71E-05
8.78E-01 4.39E-05
6.02E-01 3.01E-05
1.35E+00 * 6
2.45E+00 * 8
1.40E+01 * 8
2.05E+01'* 9
2.99E+01 * 9
8.89E+01
6.53E+01
1.14E+01
8.78E+00
6.02E+00
I
[
5.98E+01 10 3.34E-01 1.67E-05 5.98E+01 * 10 3.34E+00
2.40E+04 10 8.33E-04 4.17E-08 2.40E+04 * 10 8.33E-03 '
7.24E+02 * 4 1.10E-02 5.52E-07 7.24E+02 4 1.10E-01
t
I,
8.01E+00
1.25E+00 6.24E-05
* * * October 1986
* *
L'
-------
Directive 9285.4-1
C-32
•f
r
Date Prepared: October I. 19S6
EXHIBIT C-5
(Continued)
TOXICITY DATA FOR NONCARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Oral Route
Ir.hjlstion Route
Chemical Name
Minimum
Effective
Dose
(MED)
mg/day
Toxicity Constant
RVe
Water
(win)
1/mg
Soil
(sin)
kg/mg
Minimum
Effective
Dose
(MED)
Air
Toxicity
Constant
(aTn)
mg/day RVe m3/kg
Monoethyl Ether
Fluridone
Formaldehyde
Formic Acid
Furan
Glycidaldehyde @
Glycol Ethers (n.o.s.)
-- Diethylene Glycol, Monoethyl Ether
-- 2-Ethoxyethanol
-- Ethylene Glycol, Monobutyl Ether
-- 2-Methoxyethanol
-- Propylene Glycol
-- Propylene Glycol, Monomethyl Ether
Heptachlor (§
Heptachlor Epoxide @
Hexachlorobenzene <§
Hexachlorobutadiene @
Hexachlorocyclopentadiene
alpha-Hexachlorocyclohexane (HCCH)@
beta-HCCH @
gamma-HCCH (Lindane) @
delta-HCCH @
Hexachloroethane @
Hexachlorophene
Hydrazine @
Hydrogen Sulfide
Indeno(l,2,3-cd)pyrene @
lodomethane @
Iron and Compounds
Isobutanol
Isoprene
Isosafrole (§
Isophorone
Isopropalin
Kepone @
Lasiocarpine @
Lead and Compounds (Inorganic)
Linuron
Malathion
Manganese and Compounds
Melphalan @
l.OOE+00
1.81E+03 6 6.62E-03 3.31E-07
2.99E+01 9 6.02E-01 3.01E-05
5.50E+02 * 4 1.45E-02 7.27E-07 5.50E+02
1.40E+02
5.00E+01 10 4.00E-01 2.00E-05 5.00E+01 * 10 4.00E+00
4.49E+02 10 4.45E-01
2.99E+01 * 9 6.02E-K)0
1.45E-01
2.24E+01 10 8.93E-01 4.46E-05 2.24E+01 * 10 8.93E+00
* * * October 1986 * * *
-------
Ut>W£,K Directive 9285.4-1
C-33
Date Prepared: October 1. 19So
EXHIBIT C-5
(Continued)
I
TOXICITY DATA FOR NONCARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Oral Route
Inhalation Route
Chemical Name
Mercury and Compounds (Alkyl)
Mercury and Compounds (Inorganic) 7.60E-01
Mercury Fulminate
Methanol
Methyl Chloride
Methyl Ethyl Ketone
Methyl Ethyl Ketone Peroxide
Methyl Isobutyl Ketone
Methyl Methacrylate
Methyl Parathion
2-Methyl-4-Chlorophenoxyacetic Acid
2(2-Methyl-4-Chlorophenoxy)
propionic Acid
3-Methylcholanthrene @
4,4'-Methylene-bis-2-chloroaniline<§
Methylnitrosourea @
Methylthiouracil @
Methylvinylnitrosamine @
N-Methyl-N1 -nitro-N-nitrosoguanadine@
Mitomycin C (2
Mustard Gas @
1-Napthylamine (3
2-Napthylamine (3
Nickel and Compounds @
Nitric Oxide
Nitrobenzene
Nitrogen Dioxide
Nitrosomethylurethane @
N-Nitrosopiperidine <§
N-Nitrosopyrrolidine @
5-Nitro-o-toluidine @
Osmium Tetroxide
Pentachlorobenzene
Pentachloronitrobenzene @
Pentachlorophenol
Phenacetin @
Phenanthrene @
Phenobarbital @
Phenol
Phenylalanine Mustard @
Minimum
V £ £ £*f r ^ 1r a
c*r rect i ve
Dose
(MED)
ing/day RVe
7.60E-01 7
2.21E+02 * 10
2.58E+03 * 10
1.76E+03 4
1.07E+01 10
1
i
a/3
let"
4.70E+00 10
8.62E+02 10
2.20E-01 6
Toxic ity
Water
(win)
1/mg
1.84E+01
9.05E-02
7.75E-03
4.55E-03
1.87E+00
4.26E+00
2.32E-02
S.45E+01
Constant
Soil
(sin)
kg/mg
9.21E-04
4.52E-06
3.87E-07
2.28E-07
9.35E-05
2.13E-04
1.16E-06
2.73E-03
Minimum
r> c - _. •
LIT ect ive
Dose
(MED)
mg/day RVe
8.60E-01 8
2.21E+02 10
2.58E+03 10
1.22E+02 7
2.40E-02 5
1.27E+00 10
8.62E+02 * 10
2.20E-01 * 6
Air I
•j* • . r 1
lOXlClw^ "*
Constant
(aTn) r
m3/kg 1
1
1.86E+02 f
9.05E-01 .
7.75E-02 /
1.15E+00 r
4.17E+03 1
E
L
r
1.57E+02 I"
I
2.32E-01 *•(
5.45E+02
I
5.98E+01
l.OOE-01 5.02E-06 8.02E+01 10 2.49E-I-00
* * * October 1986 * * *
c
-------
Directive
Date Prepared: October 1. 1986
if
i:
EXHIBIT C-5
(Continued)
TOXICITY DATA FOR NONCARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Oral Route
Inhalation Route
Chemical Name
m-Phenylenediamine
Phenyl Mercuric Acetate
Phosphine
Polychlorinated Biphenyls (PCBs) @
Propane Sultone (3
Propylenimine <§ . .
Pyrene @
Pyridine
Saccharin @
Safrole @
Selenium and Compounds (n.o.s.)
-- Selenious Acid
-- Selenourea
-- Thallium Selenite
Silver and Compounds
Sodium Diethyldithiocarbamate
Streptozocin @
Strychnine
Styrene
1,2,4,5-Tet rachlorobenzene
2,3,7,8-TCDD (Dioxin) @
1,1,1,2-Tetrachloroethane @
1,1,2,2-Tetrachloroethane @
Tetrachloroethylene @
2,3,4,6-Tetrachlorophenol
2,3,5,6-Tetrachloroterephthalate
Acid (DCPA)
Tetraethyl Lead @
Thallium and Compounds (n.o.s.)
-- Thallium Acetate
-- Thallium Carbonate
-- Thallium Chloride
-- Thallium Nitrate
-- Thallic Oxide
-- Thallium Sulfate
Thioacetamide @
Thiourea @
o-Tolidine @
Toluene
o-Toluidine Hydrochloride @
Minimum
Effective
Dose
(MED)
mg/day
Toxicity Constant
RVe
Water
(wTn)
1/mg
Soil
(sTn)
kg/mg
Minimum Air
Effective Toxicity
Dose Constant
(MED) (aTn)
mg/day RVe m3/kg
1.90E-01 10 1.05E+02 5.26E-03 1.90E-01 * 10 1.05E+03
l.OOE-01
2.05E+01
2.20E+01 *
1.46E+03
1.07E+01
1.40E-03
2.00E+01 l.OOE-03 l.OOE-01 * .1 2.00E+02
9.76E-02 4.88E-06 2.05E+01 * 1 9.76E-01
5
7
8
4.55E-01 2.27E-05
9.62E-03 4.81E-07
1.50E+00 7.48E-05
2.20E+01 5 4.55E-HDO
7.27E+03 10 2.75E-02
1.07E+01 * 8 1.50E+01
7.14E+03 3.57E-01 2.50E+00 5 4.00E+01
2.69E+03 * 7 5.20E-03 2.60E-07 2.69E+03
5.20E-02
* * * October 1986 * * *
-------
OSVER Directive 9285.4-1
C-35
Date Prepared: October
1^19Sc|
EXHIBIT C-5
(Continued)
p
1 <
TOXICITY DATA FOR NONCARCINOGENIC EFFECTS
-- SELECTION OF INDICATOR CHEMICALS ONLY
Oral Route
Inhalation Route
Chemical Name
Toxaphene @
Tribromomethane (Bromoform)
1,2,4-Trichlorobenzene
1,1,1-Trichloroethane
1,1,2-Trichloroethane @
Trichloroethylene @
Trichlorofon
Trichloromonofluoromethane
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol @
2,4,5-Trichlorophenoxyacetic Acid
1,2,3-Trichloropropane
1,1,2-Trichloro-l,2,2-trifluoroethane
Tris(2,3-dibromopropyl)phosphate @
Trinitrotoluene (TNT)
Trypan Blue @
Uracil Mustard @
Uranium and Compounds
Urethane (2
Vanadium and Compounds
Vinyl Chloride (3
Warfarin
o-Xylene
m-Xylene
p-Xylene
Xylenes (mixed)
Zinc and Compounds
-- Zinc Phosphide
Zineb
Minimum
Effective
Dose
(MED)
mg/day RVe
6.60E+00 6
3.73E+01 4
5.45E+03 * 2
9.50E+00 5
4.52E+01 10
1.18E+02 6
me
1.70E+00 6
1.40E+01 1
2.28E+02 * 10
1.50E+02 8
Toxic ity
Water
(win)
1/mg
1.82E+00
2.14E-01
7.33E-04
1.05E+00
4.42E-01
1.02E-01
7.06E+00
1.43E-01
8.77E-02
1.07E-01
Constant
Soil
(sTn)
kg/rng
9.09E-05
1.07E-05
3.67E-08
5.26E-05
2.21E-05
5.10E-06
3.53E-04
7.14E-06
4.39E-06
5.33E-06
Minimum
Ef feet ive
Dose
(MED)
mg/day RVe
6.60E+00 * 6
1.32E+01 1
5.45E+03 2
2.70E+00 4
4.52E+01 * 10
1.18E+02 * 6
1.70E+00 * 6
1.40E+01 * 1
2.28E+02 10
1.50E-K32 * 8
Air f<
T*/^VT/*^T'^K
i O X 1 C 1 1 \m
Constant
(aTn) p
m3/kg f.
i
1.82E+Oir
1.52E+OC[
7.33E-03
2.96E+01/
4.42E+OCI (
1.02E+OOt-
C-
7.06E+01U
1.43E+00,
8.77E-01J '
i
1.07E+00 (
@ Potential carcinogenic effects also. See Exhibits C-3 and C-4.
* MED and RVe values marked with an asterisk are based on values for the other exposure
route.
1J Refer to Exhibit C-6 for toxicity data for risk characterization for the chemicals
listed here.
2J N.O.S. = not otherwise specified.
I
I
* * * October 1986 * * *
-------
Directive 9285.4-1
C-36
EXHIBIT C-6
Date Prepared: October 1. 1986
TOXICITY DATA FOR NONCARCINOGENIC
EFFECTS -- RISK CHARACTERIZATION x-'
Oral Route
Acceptable Intake
Inhalation Route
Acceptable Intake
Chemical Name
Acenaphthene (?
Acenaphthylene @
Acetone
Acetonitrile
2-Acetylaminofluorene (2
Acrylic Acid
Acrylonitrile (?
Aflatoxin Bl @
Aldicarb
Aldrin (3
Allyl Alcohol
Aluminum Phosphide
4-Aminobiphenyl @
Amitrole @
Ammonia
Anthracene @
Antimony and Compounds
Arsenic and Compounds @
Asbestos (3
Auramine <§
Azaserine !§
Aziridine (§
Barium and Compounds
Benefin
Benzene (3
Benzidine @
Benz(a)anthracene @
Benz(c)acridine @
Benzo(a)pyrene @
Benzo(b)fluoranthene (?
Benzo(ghi)perylene @
Benzo(k)fluoranthene @
Benzotrichloride (?
Benzyl Chloride @
Beryllium and Compounds @
1,1-Biphenyl
Bis(2-chloroethyl)ether @
Bis(2-chloroisopropyl)ether
Bis(chloromethyl)ether @
Bis(2-ethylhexyl)phthalate (DEHP)
Bromomethane
Bromoxynil Octanoate
1,3-Butadiene
* * *
Subchron Chronic Subchron Chronic
(AIS) (AIC) • (AIS) (AIC)
--mg/kg/day- Source2-1 --mg/kg/day-- Source2-
l.OOE-01
1.OOE-02
3.00E-05
5.00E-03
4.OOE-04
4.00E-04
5.10E-02
3.00E-01
5.OOE-04
5.OOE-02
RfD 3.00E+01 3.00E-KJO
HEA
8.OOE-02 RfDJJ
RfD
RfD
RfD
RfD
RfD
HEA 1.4E-3(T)*J 1.40E-04 HEA
RfD
RfD
RfD
2. OOE-02 RfD
4.OOE-04 RfD
3. OOE-02 RfD
October 1986
* * *
-------
OSWER Directive 9285.4-1
c-s:
EXHIBIT C-6
(Continued)
Date Prepared: October 1. 1956
TOXICITY DATA FOR NONCARCINOGENIC
EFFECTS -- RISK CHARACTERIZATION
Oral Route
Inhalation Route
Chemical Name
n-Butanol
Butylpthalyl Butylglycolate
Cacodylic Acid (3
Cadmium and Compounds @
Captan
Carbaryl
Carbon Bisulfide
Carbon Tetrachloride @
Chlordane (§
Chlorobenzene
Chlorobenzilate @
Chlorodibromomethane
Chloroform @
Chloromethyl Methyl Ether @
4-Chloro-o-toluidine Hydrochloride(§
Chromium III and Compounds
Chromium VI and Compounds @
Chrysene (?
Copper and Compounds
Creosote (§
Cresol
Crotonaldehyde
Cyanides (n.o.s.)
-- Barium Cyanide
-- Calcium Cyanide
-- Cyanogen
-- Cyanogen Chloride
-- Copper Cyanide
-- Hydrogen Cyanide
-- Nickel Cyanide
•- Potassium Cyanide
-- Potassium Silver Cyanide
-- Silver Cyanide
-- Sodium Cyanide
•• Zinc Cyanide
Cyclophosphamide @
Dalapon
DDD @
DDE @
DDT @
Decabromodiphenyl Ether
Diallate @
* * *
Acceptable Intake
Subchron Chronic
(AIS) (AIC)
--mg/kg/day-- Source
Acceptable Intake
Subchron Chronic
(AIS) '(AIC)
--mg/kg/day- Source
2.70E-01
l.OOE-01
l.OOE+00
l.OOE-02
2.90E-04
l.OOE-01
l.OOE-01
5.00E-05
2.70E-02
l.OOE-02
sj
1.40E+01
2.50E-02
3.70E-02
l.OOE+00
5.00E-03
3.70E-02
5.00E-02
l.OOE-02
2.00E-02
7.00E-02
4.00E-02
4.00E-02
5.00E-02
7.00E-02
2.00E-02
2.00E-02
5.00E-02
2.00E-01
l.OOE-01
4.00E-02
5.00E-02
8.00E-02
5.00E-04
l.OOE-02
RfD
HEA
HEA
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
HEA
RfD
RfD
RfD
HEA 5.30E-02 5.70E-03 HEA
RfD
5.10E-03 HEA
l.OOE-02 HEA
l.OOE-01 HEA
October 1986
* * *
-------
OSVER Directive 9285.4-1
C-36
EXHIBIT C-6
(Continued)
Date Prepared: October 1. 1966
TOXICITY DATA FOR NONCARCINOGENIC
EFFECTS -- RISK CHARACTERIZATION
Oral Route
Inhalation Route
Acceptable Intake
Acceptable Intake
Chemical Name
2,4-Diaminotoluene (§
1,2,7,8-Dibenzopyrene @
Dibenz(a,h)anthracene @
1,2-Dibromo-3-chloropropane @
Dibutylnitrosamine @
Dibutyl Phthalate
1,2-Dichlorobenzene
1,3-Dichlorobenzene
1,4-Dichlorobenzene
3,3* -Dichlorobenzidine <§
Dichlorodifluoromethane
1,1-Dichloroethane
1,2-Dichloroethane (EDC) @
1,1-Dichloroethylene @
1,2-Dichloroethylene (cis)
1,2-Dichloroethylene (trans)
Dichloromethane (§
2,4-Dichlorophenol
2,4-Dichlorophenoxyacetic
Acid (2,4-D)
4-(2,4-Dichlorophenoxy)butyric
Acid (2,4-DB)
•Dichlorophenylarsine @
1,2-Dichloropropane
1,3-Dichloropropene
Dieldrin @
Diepoxybutane @
Diethanolnitrosamine @
Diethyl Arsine @
1,2-Diethylhydrazine @
Diethylnitrosamine @
Diethyl Phthalate
Diethylstilbestrol (DES) @
Dihydrosafrole (§
Diraethoate
3,3'-Dimethoxybenzidine (§
Dimethylamine
Dimethyl Sulfate @
Dimethyl Terephthalate
Dimethylaminoazobenzene @
7,12-Dimethylbenz(a)anthracene
3,3'-Dimethylbenzidine (§
.* *
Subchron Chronic Subchron Chronic
(AIS) (AIC) (AIS) (AIC)
--mg/kg/day-- Source --mg/kg/day-- Source
l.OOE-01 RfD
2.00E-01
1.20E+00 1.20E-01
9.00E-03
6.OOE-02
3.00E-03
RfD
HEA 1.38E+00 1.38E-01
RfD
RfD
RfD
HEA
8.00E-03 RfD
1.30E+01 RfD
2.OOE-02 RfD
l.OOE-01 RfD
October 1986 * * *
-------
OSWER Directive 9285.4-1
C-39
Date Prepared: October 1, 1986
EXHIBIT C-6
(Continued)
TOXICITY DATA FOR NONCARCINOGENIC
EFFECTS -- RISK CHARACTERIZATION
Oral Route Inhalation Route
Acceptable Intake Acceptable Intake
Subchron Chronic Subchron Chronic
(AIS) (AIC) (AIS) (AIC)
Chemical Name --mg/kg/day-- Source --nig/kg/day-- Source
Dimethylcarbamoyl Chloride @
1,1-Dimethylhydrazine @
1,2-Dimethylhydrazine (§
Dimethylnitrosamine @
1, 3-Dinitrobenzene
4,6-Dinitro-o-cresol
2,4-Dinitrophenol ' . 2.00E-03 RfD
2,3-Dinitrotoluene @
2,4-Dinitrotoluene @
2,5-Dinitrotoluene (?
2,6-Dinitrotoluene @
3,4-Dinitrotoluene (3 ,, ' • - _
Dinoseb - ''"' ' 'l.OOE-03 RfD
1,4-Dioxane @
N,N-Diphenylamine (§
1,2-Diphenylhydrazine @
Dipropylnitrosamine @ . ,
Disulfoton 4.00E-03 RfD
Endosulfan ' 1.50E-05 RfD
Epichlorohydrin (? 2.00E-03 RfD
Ethanol
Ethyl Acetate 9.00E-01 RfD
Ethyl Methanesulfonate (2
Ethylbenzene 9.70E-01 l.OOE-01 RfD
Ethyl-4,4'-dichlorobenzilate @
Ethylene Dibromide (EDB) @
Ethylene Oxide @
Ethylenethiourea @
1-Ethyl-nitrosourea @
Ethylphthalyl Ethyl Glycolate 3-OOE-t-OO RfD
Ferric Dextran @
Fluoranthene @
Fluorene (?
Fluorides 6.00E-02 RfD
Fluridone 8.00E-02 RfD
Formaldehyde
Formic Acid • 2.00E+00 RfD
Furan l.OOE-03 RfD
Glycidaldehyde @
Glycol Ethers (n.o.s.)
•- Diethylene Glycol, 5.00E+00 2.00E+00 HEA
Monoethyl Ether
* * * October 1986 * * *
-------
Directive
>40
Date Prepared: October 1, 1986
•r
t
EXHIBIT C-6
(Continued)
TOXICITY DATA FOR NONCARCINOGENIC
EFFECTS -- RISK CHARACTERIZATION
Chemical Name
Oral Route
Acceptable Intake
Subchron Chronic
(AIS) (AIC)
--mg/kg/day-- Source
Inhalation Route
Acceptable Intake
Subchron Chronic
(AIS) (AIC)
--mg/kg/day-- Source
4.7E-KT) 3.60E-01 HEA
-- 2-Ethoxyethanol
-- Ethylene Glycol,
Monobutyl Ether
-- 2-Methoxyethanol
-- Propylene Glycol,
Monoethyl Ether
-- Propylene Glycol,
Monomethyl Ether
Heptachlor @
Heptachlor Epoxide @
Hexachlorobenzene (?
Hexachlorobutadiene @
Hexachlorocyclopentadiene
alpha-Hexachlorocyclohexane (HCCH)@
beta-HCCH @
gamma-HCCH (Lindane) @
delta-HCCH @
Hexachloroethane (§
Hexach 1'orophene
Hydrazine @
Hydrogen Sulfide
Indeno(l,2,3-cd)pyrene @
lodomethane (§
Iron and Compounds
Isobutanol
Isoprene
Isosafrole @
Isophorone
Isopropalin
Kepone @
Lasiocarpine @
Lead and Compounds (Inorganic)
Linuron
Malathion
Manganese and Compounds
Melphalan @
Mercury and Compounds (Alkyl)
Mercury and Compounds (Inorganic) 2.00E-03 2.00E-03
Mercury Fulminate 3.00E-03
Methanol 5.00E-01
Methyl Chloride
Methyl Ethyl Ketorie 5.00E-02
* * * October 1986 *
6.80E+00 6.80E-01
6.80E+00 6.80E-01
3.00E-05
2.00E-03
7.00E-02 7.00E-03
3.00E-04
3.00E-03
3.00E-01
2.00E-01
3.00E-02
1.40E-03
2.00E-02
5.30E-01 2.20E-01
2.80E-04 3.00E-04
HEA
HEA
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
HEA
RfD
HEA
RfD
RfD
RfD
RfD
6.9E-2(T) 5.00E-02
1.60E-01 1.60E-02
5.9E-2(T) 2.40E-02
4.90E+00 4.90E-01
2.90E-03 6.60E-05
8.60E-03
4.30E-04
3.00E-04 3.00E-04
l.OOE-04 l.OOE-04
5.10E-04 5.10E-05
HEA
HEA
HEA
HEA
HEA
HEA
RfD 2.20E+00 2.20E-01
HEA
HEA
HEA
HEA
HEA
* *
-------
OSWER Directive 9285.4-1
C-41
EXHIBIT C-6
(Continued)
Dare Prepared: October 1. 1986
TOXICITY DATA FOR NONCARCINOGENIC
EFFECTS -- RISK CHARACTERIZATION
Oral Route
Inhalation Route
Chemical Name
'Acceptable Intake
Subchron Chronic
(AIS) (AIC)
--mg/kg/day--
Source
Acceptable Intake
Subchron Chronic
(AIS) (AIC)
--mg/kg/day-- Source
2.00E-02
Methyl Ethyl Ketone Perioxide
Methyl Isobutyl Ketone
Methyl Methacrylate
Methyl Parathion
2-Methyl-4-Chlorophenoxyacetic Acid
2(2-Methyl-4-Chlorophenoxy)
propionic Acid
3-Methylcholanthrene @
4,4'-Methylene-bis-2-chloroaniline@
Methylnitrosourea @
Methylthiouracil @
Methylvinylnitrosamine @
N-Methyl-N' -nitro-S'-nitrosoguanadine@
Mitomycin C @
Mustard Gas (§
1-Napthylamine @
2-Napthylamine @
Nickel and Compounds @
Nitric Oxide
Nitrobenzene
Nitrogen Dioxide
Nitrosomethylurethane @
N-Nitrosopiperidine (§
N-Nitrosopyrrolidine @
5-Nitro-o-toluidine @
Osmium Tetroxide
Pentachlorobenzene
Pentachloronitrobenzene (3
Pentachlorophenol
Phenacetin @
Phenanthrene @
Phenobarbital (?
Phenol
Phenylalanine Mustard @
m-Phenylenediamine
Phenyl Mercuric Acetate
Phosphine
Polychlorinated Biphenyls (PCBs) @
Propane Sultone @
Propylenimine <§
Pyrene @
Pyridine
* -* * October
.OOE-03
.OOE-02
1.OOE-03
3.OOE-03
RfD
RfD
RfD
RfD
1.OOE-02
l.OOE-01
5.00E-04
l.OOE-t-00
l.OOE-05
8.00E-04
8.OOE-03
3.0E-2(T) 3.OOE-02
HEA
RfD
RfD
RfD
RfD
RfD
RfD
RfD
l.OOE-01 l.OOE-01 RfD 1.90E-01 2.OOE-02
HEA
OOE-03
OOE-05
OOE-04
RfD
RfD
RfD
2.OOE-03
1986
RfD
* * *
-------
OSVER Directive 9285.4-1
c-4:
Date Prepared: October 1. I9S6
EXHIBIT C-6
(Continued)
TOXICITY DATA FOR NONCARCINOGENIC
EFFECTS -- RISK CHARACTERIZATION
Oral Route
Inhalation Route
Chemical Name
Saccharin @
Safrole @
Selenium and Compounds (n.o.s.)
-- Selenious Acid
-- Selenourea
-- Thallium Selenite
Silver and Compounds
Sodium Diethyldithiocarbamate
Streptozocin @
Strychnine
Styrene
1, 2,4,5-Tetrachlorobenzene
2,3,7,8-TCDD (Dioxin) @
1,1,1,2-Tetrachloroethane @
1,1,2,2-Tetrachloroethane @
Tetrachloroethylene @
2,3,4,6-Tetrachlorophenol
2,3,5,6-Tetrachloroterephthalate
Acid (DCPA)
Tetraethyl Lead (2
Thallium and Compounds (n.o.s.)
-- Thallium Acetate
-- Thallium Carbonate
-- Thallium Chloride
-- Thallium Nitrate
-- Thallic Oxide
-- Thallium Sulfate
Thioacetamide @
Thiourea @
o-Tolidine (§
Toluene
o-Toluidine Hydrochloride (3
Toxaphene @
Tribromomethane (Bromoform)
1,2,4-Trichlorobenzene
1,1,1-Trichloroethane
1,1,2-Trichloroethane @
Trichloroethylene @
Trichlorofon
Trichloromonofluororaethane
2/4,5-Trichlorophenol
2,4,6-Trichlorophenol @
* * *
Acceptable Intake
Subchron Chronic
(AIS) (AIC)
--mg/kg/day- Source
Acceptable Intake
Subchron Chronic
(AIS) (AIC)
--mg/kg/day-- Source
3.20E-03 3.00E-03
3.00E-03
5.00E-03
5.00E-04
3.00E-03
3.00E-02
3.00E-04
2.00E-01
3.00E-04
2.00E-02
l.OOE-02
OOE-02
OOE-07
4.00E-04
5.00E-04
4.00E-04
5.00E-04
5.00E-04
4.00E-04
S.OOE-04
HEA
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
RfD
l.OOE-03
HEA
4.30E-01 3.00E-01 RfD 1.50E+00 1.50E+00
2.OOE-02 RfD
5.40E-01 HEA
3.00E-01 RfD
l.OOE-KJO l.OOE-01 RfD
1.10E+01 6.30E+00
HEA
HEA
October 1986
* * *
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C-43
EXHIBIT C-6
(Continued)
OSWER Directive 9285.4-1
Date Prepared: October 1. 1986
TOXICITY DATA FOR NONCARCINOGENIC
EFFECTS -- RISK CHARACTERIZATION
Chemical Name
2,4,5-Trichlorophenoxyacetic Acid
1,2,3-Trichloropropane
l,l,2-Trichloro-l,2,2-
Trifluoroethane
Tris(2,3-dibromopropy1)phosphate @
Trinitrotoluene (TNT)
Trypan Blue @
Uracil Mustard @
Uranium and Compounds
Urethane @
Vanadium and Compounds
Vinyl Chloride @
Warfarin
o-Xylene
m-Xylene
p-Xylene
Xylenes (mixed)
Zinc and Compounds
-- Zinc Phosphide
Zineb
Oral Route
Acceptable Intake
Subchron Chronic
(AIS) . (AIC)
--mg/kg/day- Source
Inhalation Route
Acceptable Intake
Subchron Chronic
(AIS) (AIC)
--mg/kg/day-- Source
3.00E-02
l.OOE-01
3.00E+01
2.00E-04
RfD
RfD
RfD
RfD
2.00E-02 RfD
3.00E-04 RfD
l.OOE-01 l.OOE-02 HEA
l.OOE-01 l.OOE-02 HEA
l.OOE-01 l.OOE-02 HEA
2.10E-01 2.10E-01 HEA
3.00E-04 RfD
5.00E-02 RfD
9.6E-KT) 2.00E-01 HEA
l.OOE-KJO 2.00E-01 HEA
6.9'E-1(T) 4.00E-01 HEA
l.OOE-01 l.OOE-02 HEA
(§ Potential carcinogenic effects also. See Exhibits C-3 and C-4.
1J Refer to Exhibit C-5 for toxicity data for indicator selection for the
chemicals listed here.
2J Sources for Exhibit C-6:
RfD = Agency-wide reference dose value, developed by an inter-office work group
chaired by the Office of Research and Development, U.S. EPA, Washington, D.C.,
1986.
HEA - Health Effects Assessment document, prepared by the Environmental Criteria
and Assessment Office, U.S. EPA, Cincinnati, Ohio, 1985 (updated in May 1986).
JJ The RfD values listed here are EPA-verified numbers. All RfD values were
derived based on oral exposure; however, in the absence of other more specific data,
these values may also be useful in assessing risks of inhalation exposure.
*J T indicates that teratogenic or fetotoxic effects are the basis for the AIS
value listed.
IJ N_.O.S. = not otherwise specified.
* * * October 1986
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C-44
EXHIBIT C-7
CHEMICALS AND CHEMICAL GROUPS HAVING EPA HEALTH
EFFECTS ASSESSMENT (HEA) DOCUMENTS lj
CHEMICAL
NTIS2J PB NUMBER
Acetone
Arsenic and Compounds
Asbestos
Barium and Compounds
Benzene
Benzo(a)pyrene
Cadmium and Compounds
Carbon Tetrachloride
Chlordane
Chlorobenzene
Chloroform
Chromium III and Compounds
Chromium VI and Compounds
Coal Tars
Copper and Compounds
Cresol
Cyanides
DDT
1,1-Dichloroethane
1,2-Dichloroethane (EDC)
1,1-Dichloroethylene
1,2-cis-Dichloroethylene
1,2-trans-Dichloroethylene
Dichloromethane
Ethylbenzene
Glycol Ethers
Hexachlorobenzene
Hexachlorobutadiene
Hexachlorocyclopentadiene
gamma-Hexachlorocyclohexane (Lindane)
Iron and Compounds
Lead and Compounds (Inorganic)
Manganese and Compounds
Mercury
Methyl Ethyl Ketone
Naphthalene
Nickel and Compounds
Pentachlorophenol
Phenanthrene
Phenol
Polychlorinated Biphenyls (PCBs)
86 134277/AS
86 134319/AS
86 134608/AS
86 134327/AS
86 134483/AS
86 134335/AS
86 134491/AS
86 134509/AS
86 134343/AS
86 134517/AS
86 134210/AS
86 134467/AS
86 134301/AS
86 134350/AS
86 134368/AS
86 134616/AS
86 134228/AS
86 134376/AS
86 134384/AS
86 134137/AS
86 134624/AS
86 134269/AS
86 134525/AS
86 134392/AS
86 134194/AS
86 134632/AS
86 134285/AS
86 134640/AS
86 134129/AS
86 134673/AS
86 134657/AS
86 134665/AS
86 134681/AS
86 134533/AS
86 134145/AS
86 134251/AS
86 134293/AS
86 134541/AS
86 134400/AS
86 134186/AS
86 134152/AS
* * * October 1986 * * *
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OSWER Directive 9285.4-1
C-45
' EXHIBIT C-7
(Continued)
CHEMICALS AND CHEMICAL GROUPS HAVING EPA HEALTH
EFFECTS ASSESSMENT (HEA) DOCUMENTS 1J
CHEMICAL
NTIS2J PB NUMBER
Polynuclear Aromatic Hydrocarbons
Pyrene
Selenium and Compounds
Sodium Cyanide
Sulfuric Acid
2,3,7,8-TCDD (Dioxin)
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichloroethylene
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
Vinyl Chloride
Xylene
Zinc and Compounds
Complete Set of 58 HEAs
86 134244/AS
86 134418/AS
86 134699/AS
86 134236/AS
86 134426/AS
86 134558/AS
86 134434/AS
86 134202/AS
86 134442/AS
86 134160/AS
86 134566/AS
86'134574/AS
86 134459/AS
86 134582/AS
86 134475/AS
86 134178/AS
86 134590/AS
86 134111/AS
l- As of the date of publication for this manual.
*-' National Technical Information Service.
October 1986
* *
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APPENDIX D
DETAILED PROCEDURES FOR DETERMINING TOXICITY
CONSTANTS FOR INDICATOR CHEMICAL SELECTION
t
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APPENDIX D
DETAILED PROCEDURES FOR DETERMINING TOXICITY
CONSTANTS FOR INDICATOR CHEMICAL SELECTION
The method for selecting indicator chemicals for a site, described in
Chapter 3 of this manual, requires the determination of toxicity constants
(T). For many chemicals, these values are given in Appendix C. This appendix
(Appendix D) presents methods for calculating toxicity constants for chemicals
not listed in Appendix C. If, in the process of preparing a public health
evaluation for a site, such chemicals are found, you should request help from
EPA headquarters before doing these calculations. As new information becomes
available or new chemicals are identified as problems, the list in Appendix C
will be updated and expanded.
Toxicity constants, T, are medium-specific. A toxicity constant for use
w
with drinking water concentrations is referred to as T, whereas one for
concentrations in air is T, and and one for concentrations in soil is
T. Toxicity constants for potential carcinogens are based on the
ED nlj; for noncarcinogens they are based on the minimum effective dose
(MED) and a severity of effects rating. All toxicity constants also have
standard intake assumptions built in. Units of toxicity constants are the
inverse of concentration units.
Values of T, T, and T for a variety of compounds are given in
Appendix C. In the event that values are not present in Appendix C, they can
be calculated as follows:
Potential Carcinogens
w 2 liters drinking water/day
Tc = [1]
70 kg • ED1Q
s 0.0001 kg soil/day
Tc = [2]
70 kg • ED1Q
a 20 m3 air/day
Tc = [3]
70 kg • ED1Q
1J ED.0 = dose in mg/kg/day at which 10% incidence above control is
observed for a tumor type showing a statistically significant incidence.
* * * October 1986 * * *
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OSWER Directive 9285.4-1
D-2
where the ED1f. is derived from carcinogenicity dose-response data and is
expressed in mg/kg/day.
Noncarcinogens
w 2 liters drinking water/day • RVe
Tn = [4]
MED (oral)
s 0.0001 kg soil/day • RVe
Tn = [5]
MED (oral)
a 20 mj air/day • RVe
Tn = [6]
MED (inhalation)
where RVe is a rating value based on the severity of effect and scored as
indicated in Exhibit D-l, and.MED is the human minimum effective dose in
rag/day for a given effect. If the MED is given in mg/kg/day, multiply it by
70 and then substitute it into the above equation.
The soil toxicity constant (ST) is incorporated as a way to estimate the
overall exposure that might be contributed by contaminated soil. Inclusion of
T in the indicator selection process is a way to use the soil concentration
data gathered in most site characterizations, in part so that compounds found
in soil and not in air and water could be considered in indicator compound
scoring. The T equation is based on a child's consumption of contaminated
soil as detailed in a recent ORD risk assessment of contaminated soil (EPA,
1984).
The ORD document estimates that children between the ages of two and six
consume at least 100 mg of soil per day, and that in situations of direct
ingestion of soil (i.e., pica) the rate could go as high as 5 g per day. The
lower value was selected for this procedure because it was more comparable to
the standard consumption values used in calculating the other T values. The 5
g per day value is representative of a pathologic state (pica), and using it
to calculate T would correspond to assuming 8 liters or more as the daily
consumption of water (to reflect the diabetic who consumes 8 liters of water
per day).
Although Equations 2 and 5 are based on ingestion by a child, the intake
is not normalized to an equivalent lifetime intake. The equations use an
intake rate during childhood rather than an lifetime average daily intake to
ensure that compounds are identified on the basis of their potential to harm a
child. Thus, the equations compare a child's dally intake rate to a lifetime
average daily intake (expressed as an MED or an ED ), which, strictly
speaking, may be inappropriate. Unfortunately, the most appropriate data to
use, dose-response information for children, do not exist, and even data for
dose-response relationships in immature animals are rare. What little
* * * October 1986 * * *
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D-3
EXHIBIT D-1
RATING CONSTANTS (RVe) FOR NONCARCINOGENS^
Severity
Effect Rating (RVe)
Enzyme induction or other biochemical change with no pathologic .- 1
changes and no change in organ weights.
Enzyme induction and subcellular proliferation or other changes 2
in organelles but no other apparent effects.
Hyperplasia, hypertrophy or atrophy, but no change in organ 3
weights.
Hyperplasia, hypertrophy or atrophy with changes in organ weights. . A
Reversible cellular changes: cloudy swelling, hydropic change, 5
or fatty changes.
Necrosis, or metaplasia with no apparent decrement of organ '. 6
function. Any neuropathy without apparent behavioral, sensory,
or physiologic changes.
Necrosis, atrophy, hypertrophy, or metaplasia with a detectable 7
decrement of organ functions. Any neuropathy with a measurable
change in behavioral, sensory, or physiologic activity.
Necrosis, atrophy, hypertrophy, or metaplasia, with definitive 8
organ dysfunction. Any neuropathy with gross changes in behavior,
sensory, or motor performance. Any decrease in reproductive
capacity, any evidence of fetotoxicity.
Pronounced pathologic changes with severe organ dysfunction. Any 9
neuropathy with loss of behavioral or motor control or loss of
sensory ability. Reproductive dysfunction. Any teratogenic
effect with maternal toxicity.
Death or pronounced life-shortening. Any teratogenic effect with- 10
out signs of maternal toxicity.
1J Rating scale identical to that used by EPA in the RQ adjustment
process, as described in EPA (1983).
*. * * October 1986 * * *
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OStfER Directive 9285.4-1
D-4
information is available seems to indicate that the young are generally more
sensitive to the toxic effects of chemicals than adults. Although this
approach is not strictly accurate it errs on the more protective side, while
at the same time achieving the goal of being a simple way to incorporate soil
concentration information into the indicator selection process.
Although not used directly in the calculation of indicator scores for
potential carcinogens, a qualitative weight-of-evidence rating is considered
in the final selection of indicators. The EPA weight-of-evidence criteria
(EPA, 1986) are given in Exhibit D-2 and should be used to categorize
potential carcinogens not listed in Appendix C. The EPA approach for
determining weight of evidence is similar to the International Agency for
Research on Cancer (IARC) approach, differing primarily by having an
additional category for "no evidence of carcinogenicity in humans" and revised
criteria for defining evidence as "sufficient", "limited", or "inadequate."
REFERENCES FOR APPENDIX D
U.S. EPA, 1983. .Methodology and Guidelines for Reportable Quantity
Determinations Based on Chronic Toxicity Data, External Review Draft.
Prepared by the Environmental Criteria and Assessment Office, Office of Health
and Environmental Assessment. ECAO-CIN-R245.
U.S. EPA, 1986. Guidelines for Carcinogen Risk Assessment. Federal
Register 51:33992.
U.S. EPA, 1984. Risk Analysis of TCDD Contaminated Soil. Prepared by the
Exposure Assessment Group, Office of Health and Environmental Assessment. EPA
600/8-84-031.
* * * October 1986 * * *
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OSWER Directive 9285.4-1
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EXHIBIT D-2
EPA WEIGHT-OF-EVIDENCE
CATEGORIES FOR POTENTIAL CARCINOGENS
EPA
Category
Description
of Group
Description of Evidence
Group A Human Carcinogen Sufficient evidence from epidemiologic studies
to support a causal association between exposure
and cancer
Group Bl
Probable Human
Carcinogen
Limited evidence of carcinogenicity in humans
from epidemiologic studies
Group B2 Probable Human
Carcinogen
Sufficient evidence of carcinogenicity in
animals, inadequate evidence of carcinogenicity
in humans
Group C
Possible Human
Carcinogen
Limited evidence of carcinogenicity in animals
Group D Not Classified Inadequate evidence of carcinogenicity in animals
Group E No Evidence of No evidence for carcinogenicity in at least two
Carcinogenicity adequate animal tests or in both epidemiologic
in Humans and animal studies
* * * October 1986
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turective 9285.4-1
APPENDIX E
MEMORANDUM OF UNDERSTANDING
BETWEEN
THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY
AND
THE/UNITED. STATES ENVIRONMENTAL PROTECTION AGENCY
April 2, 1985
* * * ' October 1986 * * *
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MEMORANDUM OF UNDERSTANDING
BETWEEN
THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY
AND
THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
1. PURPOSE
The Agency for Toxic Substances and Disease Registry
(ATSDR) and the Environmental Protection Agency (EPA) agree
that guidance is required to define and coordinate joint and
respective responsibilities under the Comprehensive Environ-
mental Response, Compensation, and Liability Act (Public Law
96-510, 94 Stat. 2796, 42 USC 9601 et seq; CERCLA), Executive
Order 12316 (Responses to Environmental Damage), and the
National Oil and Hazardous Substances Contingency Plan (NCP;
40 CFR Part 300). This Memorandum of Understanding (MOU)
establishes oolicies and procedures for conducting response
and non-response health activities related to releases of
hazardous substances.
2. AUTHORITY
CERCLA section 104 authorizes the President to respond
to releases or substantial threats of releases into the
environment of hazardous substances and certain releases of
pollutants or contaminants. CERCLA also establishes the
Hazardous Substance Response Trust Fund. CERCLA section 104(i)
authorizes ATSDR (part of the Department of Health and Human
Services (HHS)) to effectuate and implement specific health-
related activities with the cooperation of EPA and other agencies
Executive Order 12316 further delegates to the Secretary- of
HHS certain investigatory authorities vested in the President
under CERCLA section 104 for conducting activities with the
cooperation of other agencies, relating to illness, disease or
complaints thereof. Executive Order 12316 delegates to EPA
the primary resoonse authority under CERCLA section 104
relating to release or extent of release of hazardous sub-
stances, pollutants, or contaminants, and determination of
the presence of an imminent and substantial danger to the
public health or welfare or the environment. Exceptions to
this authority include responses to releases from Department
of Defense (DOD) facilities or vessels (delegated to DOD) and
releases involving the coastal zone, Great Lakes waters,
ports, and harbors (delegated to the U.S. Coast Guard).
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OSVER Directive 9285.4-1
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3. SCOPE OF RESPONSIBILITIES
This MOU covers the coordination of health-related
activities by ATSDR and EPA as authorized bv CERCLA and
delegated by Executive Order 12^16. ATSDR has statutory
responsibilities under CERCLA and Executive Order 12316 for
activities related to illness, disease, or complaints thereof,
for disease registries and other responsibilities related to
response actions. EPA has statutory authority under CERCLA
and Executive Order 12316 for activities related to release
or threat of release of hazardous substances, pollutants or
contaminants, and for determination of the extent of .danger
to public health, welfare or the environment, as well as,
other responsibilities related to response actions.
ATSDR and EPA will carry out their responsibilities
according to CERCLA, Executive Order 12316, the NCP, and
'this MOU. ATSDR's major responsibility will be the
evaluation of populations with current or potential exposure
to waste sites, development of health advisories, and the
follow up on populations for the evaluation of future health
effects. EPA's major responsibility in the health area will
.be risk assessment and risk management as defined herein.
Health advisories will be based on ATSDR's evaluations of
current health effects and will adapt EPA's risk assessments
at a site or sites. ATSDR will not perform risk assessments
as defined herein, using the funds made available from the
Hazardous Substances Response Trust Fund. If risk assessments
are not available ATSDR will consult EPA on a case-by-case
basis. ATSDR will conduct some of its activities through
interagency agreements with other participating agencies of
the Public Health Service through cooperative agreements with
State health departments, and through contractual arrangements
whenever appropriate. Such interagency agreements include
those with the Centers for Disease Control to conduct health
studies and conduct research and provide assistance on worker
health and safety issues; with the Library of Medicine to
establish and maintain the needed data bases on health'effects
of toxic substances; and with the National Toxicology Program
to conduct standard toxicological assays.
Definitions for the key terms used in this section follow;
0 Health Consultation; Immediate or short-term
consultation by ATSDR to provide health advice and/or
health effects information regarding a specific site.
° Health Assessment; Initial multi-disciplinary reviews
by ATSDR of all readily available data to evaluate
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the nature and magnitude of any threat to human
health at a site. These evaluations will adapt
EPA's risk assessment for the characterization of
potential health threats at a site or sites, and may
include literature searches, information summari-
zation and evaluation of existing environmental data,
pilot samples, testing for food chain contamination,
and similar activities.
0 Public Health Advisory; An advisory issued by ATSDR
based on the results of its health assessment.
0 Epidemiologic Studies; Long-term epidemiologic study
by ATSDR involving a comprehensive protocol designed
to add knowledge of the health effects of a specific
substance or substances at a site or sites.
0 Health Registry; A site-specific or adverse health
effects-specific registry established and maintained
to track specific diseases and illnesses and long-
term health effects to persons exposed to toxic
substances.
° Pilot Study: A preliminary or short term medical,
laboratory, or epidemiologic study on a limited human
peculation to decide if additional, large scale
studies are warranted. The study populations can
include those living at, or near, a site and those
not residing at, or near, a site (control or reference
population).
0 Risk Assessment; A qualitative/quantitative process
conducted by EPA to characterize the nature and
magnitude of potential risks to public health from
exposure to hazardous substances, pollutants or
contaminants released from specific sites. This
process consists of hazard identification, dose-
response assessment, exposure assessment, and risk
characterization and supports EPA's risk management
process.
0 Risk Management; The process conducted by EPA to
determine the nature and extent of remedy for a site,
including alternative selection.
A. Removal Actions
Removal actions are Superfund response activities
involving the short-term cleanup or removal of released
hazardous substances that pose an immediate hazard. These
actions generally are limited by CERCLA to $1 million in cost
and six months in.duration.
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OSVER Directive 9285.4-1
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ATSDR activities in support of soecific removal
actions involve health consultations and health advisories.
In addition, ATSDR may monitor the health of residents who
have been exposed to the hazardous substances or who live
near the release site. ATSDR may also provide technical
assistance to EPA on matters of worker health and safety
during the removal and may provide community relations
assistance to EPA. ATSDR may become involved in removal
actions through a variety of mechanisms and at various stages
of a removal action. The On-Scene Coordinator (OSC) shall
recommend that ATSDR be called in at any time during the
removal action, at the time that the criteria under Section
B.3 are met, unless in the OSC's opinion there is no need for
further public health input into the removal action. Altern-
atively, the recommendation for ATSDR involvement may be
initiated by ATSDR itself, the State, or the EPA Regional
Administrator.
" B. Remedial Response
Remedial actions are those response actions consistent
with a permanent remedy at a site. Remedial action is
preceded by detailed planning. This section discusses
coordination of ATSDR and EPA efforts during the remedial
response process, which involves five major stages:
0 Site discovery, preliminary
assessment, and site inspection;
0 Site ranking and NPL listing;
0 Remedial investigation (RI);
0 Feasibility study (FS); and
0 Remedial design and construction.
The roles of ATSDR and EPA during these stages are
discussed in the subsections below.
B.I Site Discovery, Preliminary Assessment, a-nd Site
Inspection
There are different methods for identifying sites for
potential remedial response under the Superfund program.
CERCLA section 103 requires certain parties to notify the
National Response Center when they have knowledge of a
release of a hazardous substance equal to or in excess of the
reportable quantity for that substance. Notification is
forwarded to EPA and the affected State. In addition to this
formal notification process, EPA may receive notification of
a potential or actual release from a local, State, or Federal
agency that discovers the release in the performance of its
responsibilities. Following notification of a potential or
actual release, EPA conducts a preliminary assessment of the
site to determine whether further investigation and Hazard
Ranking System (HRS) scoring is warranted.
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Site discovery, preliminary assessment, and site
inspection are primarily the responsibility of EPA. If
ATSDR discovers a potential or actual release during the
performance of its responsibilities, ATSDR will notify EPA
of this release. EPA may perform preliminary assessments and
site inspections of such releases, as warranted, and will
determine whether further investigation is necessary.
B.2 Site Ranking and NPL Listing
CERCLA section 105(8) reouires the President to develop
criteria for determining priorities among releases or
threatened releases of hazardous substances and, based upon
those criteria, publish and amend the NPL. Executive Order
12316, section l(c) delegates to EPA "[t]he responsibility
for. . .all of the. . .functions vested in section 105" of
CERCLA.
Decisions regarding snecific site scoring and listing of
'sites on the NPL are the responsibility of EPA. If ATSDR
discovers any information about potential candidates for the
NPL during the performance of its responsibilities, ATSDR
will submit that information to ^PA. To facilitate this, EPA
Keadouarters will notify ATSDR prior to each amendment of the
NPL to allow ATSDR to recommend sites to be considered for
the NPL, and EPA will consider such recommendations, based upon
the data used by ATSDR to make the recommendation, before
publishing the amended NPL. EPA may decide to rank sites
identified by ATSDR, retain the site information on EPA files
for future reference, or seek further information about such
sites, and will notify ATSDR of its decision.
B.3 Remedial Investigation
CERCLA section 104(b) authorizes the President to under-
take "such investigations, monitoring, surveys, testing, and
other information gathering" necessary to "identify the
existence and extent of the release or threat thereof, the
source and nature of hazardous substances, pollutants or
contaminants involved, and the extent of danger to public
health or welfare or the environment." Section 2(a) of
Executive Order 12316 delegates to the Secretary of HHS in
cooperation with other agencies, those functions of Section
104(b) "relating to illness, disease, or complaints thereof."
HHS's responsibilities are performed by ATSDR. Section 2(e)
delegates to EPA most of the remaining authorities under
section 104, including those functions under section 104(b)
listed above as they relate to the occurrence or potential
occurrence of a release.
The EPA Regional Administrator, or his designee, will
determine as early as possible in the RI/FS process for a
site whether concurrent ATSDR involvement in the RI/FS is
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OSWER Directive 9285.4-1
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necessary. In deciding whether to request concurrent ATSDR
involvement, the Regional Administrator, or his designee,
will consider the following criteria:
0 Whether the presence of toxic substances has been
confirmed at the site;
0 Whether pathways of huma". exposure to toxic substances
have been demonstrated to exist at the site, especially
if such pathways involve direct contact with toxic
substances; and
*
0 Whether a human population has been exposed to toxic
substances via the identified pathways, and whether
there exists a threat of current or future health
effects to the population being so exposed, after
considering EPVs risk assessments or health
effects information from other sources.
If these criteria are met, the EPA Regional Administrator, or
his designee, shall request concurrent ATSDR involvement,
unless in his opinion there is no need for further public
health input into the RI/FS. Alternatively, the recommendation
.for ATSDR involvement may be initated by ATSDR itself, or the
State.
Elements of the remedial investigation in which ATSDR
participates may include review of site sampling plans and
analysis protocols, site sampling, data analysis and interpre-
tation, worker health and safety, community relations, and the
remedial investigation report. The division'of responsibilities
and coordination between EPA and ATSDR in conducting these
activities is described in the following paragraphs. EPA and
ATSDR will agree to strict time schedules on a site-specific
basis for all activities to be performed by ATSDR, to ensure
that the response process is not delayed. Any changes in the
time schedule will be mutually aareed upon by EPA and ATSDR.
Site Sampling. Where EPA has requested concurrent ATSDR
involvement, ATSDR will advise EPA during the preparation of
sampling and analysis protocols to ensure collection of data
useful to ATSDR for health assessments and epidemiological
studies. EPA will be responsible for the development and
conduct of any environmental and biological (other than
human) sampling, and developing the tests therefor. ATSDR
will consult with appropriate health agencies and will summarize
recommendations regarding the necessity for testinq of human
.subjects. If human subject testing is determined to be
necessary, ATSDR will be responsible for any such testing.
EPA shall review the protocols or sampling plans for such
testing to ensure collection of data useful to EPA in perform-
ing subsequent risk assessment and risk management.
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Sampling Protocol. Where EPA has reauested concurrent
ATSDR involvement, SPA and ATSDR will submit a draft of all
protocols to each other for review prior to institution of
any site sampling or monitoring. Any changes in the sampling
protocols will also be provided to ATSDR for review. With
regard to the review of non-site soecific protocols, (e.g.,
protocols for standard Contract Laboratory Program analysis)
EPA will provide these to ATSDR for review as early as possible
to avoid the necessity of ATSDR review of these protocols on
a site specific basis.
Data Analysis and Interpretation. At sites where EPA
has requested concurrent ATSDR involvement, EPA will-provide
its data from environmental, toxicological and other biolog-
ical sampling and testing to ATSDR. ATSDR will review all
available data for a site, including EPA's hazard identifi-
cation, dose-response assessment, exposure assessment, and
risk characterization information, drawing conclusions about
any threats to public health associated with the site. Based
on its interpretation of the site data, ATSDR will characterize
the health threats based on its evaluation of current health
effects and in consultation with EPA concerning the magnitude
and timing of potential future health effects. ATSDR will
communicate all health concerns to regional EPA staff and
will provide copies of health assessments and advisories to
EPA.
Worker Health and Safety. EPA may request assistance
from ATSDR on worker health and safety issues during a
remedial investigation, includina consultation on the design
of worker health and safety plans and monitoring of plan
implementation. ATSDR will make arrangements for laboratory
and field testing related to worker health and safety and
worker surveillance.
Community Relations. ATSDR may provide, at EPA's request,
assistancein conducting community relations activities durina
the remedial investigation. Such assistance may include:
0 Preparation of technical and non-technical information
material for the public describing human health threats
posed by substances at a site;
0 Reviewing and commenting on human health-related
documents prepared and submitted by citizens
(e.g., citizen-generated health survey protocols);
Participation in public meetings,
meetings, and workshops; and
small group
0 Preparing responses to specific public inquiries
regardinq human health impacts of site problems.
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OSVER Directive 9285.4-1
-8-
Remedial Investigation Report. At the conclusion of the
remedial investigation at sites where ATSDR is involved, EPA
will send a copy of the remedial investigation report to ATSDR.
ATSDR will review health-related data and interpretations of
such data in the report and provide comments to EPA within a
mutually agreed upon time frame.
If EPA and ATSDR agree that ATSDR involvement is not
required at a site, ATSDR will not participate in the remedial
planning process at that site. ATSDR may undertake other
statutory activities, such as epidemiological studies or
disease registries, at a site or sites. ATSDR will coordinate
all such activities with EPA and will advise EPA of imminent
threats to human health at any site and at any time during
EPA's remedial process. In addition, EPA may request ATSDR
assistance in disseminating health information to the public
and in responding to health concerns of local citizens.
'B.4 Feasibility Study
EPA has the final authority for determining the extent
of remedy at a site and selecting a specific remedy during
the feasibility study. In conducting feasibility studies,
EPA will develop, evaluate, and select remedial options using
the approach described in its feasibility study guidance. For
those sites where there has been concurrent ATSDR involvement,
EPA staff will consult ATSDR for its assessment of any
human health data (e.g., clinical, epidemiologic) and EPA's
risk assessment resulting from the remedial investigation.
EPA will be responsible for performing qualitative/quantitative
risk assessments evaluating long-term risks to the public that
may result from exposure to hazardous substances from Superfund
sites.
It is the responsibility of EPA (Office of Solid Waste
and Emergency Response) to incorporate the results of the
risk assessment process and of health assessments by ATSDR
into risk management determinations of the extent of remedy
for a site. The goal of this process is to ensure that_the
remedial action is adequate with reqard to eliminating or
mitigating the existing and future public health threats.
EPA may consider and incorporate applicable information
provided by ATSDR on the current status of public health at
the site into the selection of the preferred remedy. At the
discretion of the appropriate Regional Administrator, EPA
staff may also consult with ATSDR staff for any interpre-
tation of human health data at sites where ATSDR is not
concurrently involved. In addition, EPA may request ATSDR
assistance at any site in disseminating health information to
the public and in responding to health concerns of local
citizens. In the course of performing its health activities,
should ATSDR discover any site which, in its opinion, poses
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OSWER Directive 9285.4-1
-9-
an imminent threat to public health, ATSDR will immediately
notify the relevant EPA Regional Office and EPA Headquarters
of this finding.
For each remedial response site where ATSDR involvement
is reauested , EPA will provide ATSDR with a copy of the
draft feasibility study, and where appropriate with rough
draft sections of the feasibility study relating to human
health and interpretation, prior to the public comment period
if possible. ATSDR will review the interpretation of the
human health data in the draft feasibility study and provide
comments to EPA during the public comment period. ATSDR will
also provide to EPA any health information it possesses on
the site during the public comment period
B.5 Remedial Design and Construction
The design and construction of the selected remedy at
Superfund sites' is EPA's responsibility. The Regional
Administrator may, at his discretion, request a health
assessment from ATSDR with regard to certain elements of the
remedial design. At the conclusion of the design stage,
EPA should provide advance copies of the Remedial Design and
Construction Plans to ATSDR whenever possible if they wish
review and comment by ATSDR. ATSDR will notify EPA if the
remedial design does not, in its opinion, eliminate or miti-
gate the public health threat.
C. Cost Recovery
Under CERCLA, EPA is authorized to recover from responsible
parties all government costs incurred during a response
action. ATSDR agrees to conform with all procedures and
requirements for documenting costs that are to be recovered.
D. Funding
All costs incurred by ATSDR in performing its CERCLA
responsibilities are funded by ATSDR through funds provided
for this purpose. Funding for ATSDR activities performed
under CERCLA is from the Hazardous Substances Response Trust
Fund and is provided by EPA through the budget task force
required by Section 7 of Executive Order 12316 or through
seoarate interagency agreements for specific health studies.
ATSDR will comply with the financial and reporting requirements
outlined in the Interagency Agreements that transfer Fund
monies to ATSDR.
4. PERIOD OF AGREEMENT
This Memorandum of Undprstanding will continue in effect
until modified or amended by the assent of both parties or
terminated by either party uoon a thirty (30) day advance
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OStfER Directive 9285.4-1
-10-
written notice of the other party. Nothing in the Memorandum
is intended to diminish or otherwise alter statutory authority
of the agencies involved.
5. AMENDMENTS
This Memorandum may be amended at any time by the agree-
ment of both parties. Each amendment must be in writing and
signed by the appropriate ATSDR and EPA officials.
6. EFFECTIVE DATE
This Memorandum will become effective at noon CKI the date
of the last signature below.
Date:
MAY ?
For the Agency for Toxic
Substances and Disease
Registry
y-7. r-
For the United States
Environmental Protection
Agency
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