PB91-161539
Ambient Water Quality Criteria Document
Addendum for Antimony
(U.S.) Environmental Protection Agency, Cincinnati, OH
May 89
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FINAL DRAFT
United Stitti ECAO-C1N-617
Environmental Protection
Agency
oEPA Research and
Development
AMBIENT WATER QUALITY CRITERIA DOCUMENT
ADDENDUM FOR ANTIMONY
Prepared for
OFFICE OF WATER REGULATIONS
AND STANDARDS
Prepared by
Environmental Criteria and Assessment Office
Office of Health and Environmental Assessment
U.S. Environmental Protection Agency
Cincinnati, OH 45268
DRAFT: DO NOT CITE OR QUOTE
NOTICE
This document Is a preliminary draft. It has not been formally released
by the U.S. Environmental Protection Agency and should not at this stage be
construed to represent Agency policy. It Is being circulated for comments
on Its technical*accuracy and policy Implications.
REPRODUCED BY
U.S. DEPARTMENT OF COMMERCE
NATIONAL TECHNICAL
INFORMATION SERVICE
SPRINGFIELD, VA 22161
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DISCLAIMER
This report 1s an external draft for review purposes only and does not
constitute Agency policy. Mention of trade names or commercial products
does not constitute endorsement or recommendation for use.
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PREFACE
Under the 1977 Clean Water Act, Congress mandated the U.S. Environmental
Protection Agency to develop ambient water quality criteria for 129 priority
pollutants. These criteria were published In 1980. Under Section 304(a)(l)
of the Clean Water Act as amended In 1987, the U.S. EPA 1s mandated to
re-evaluate anc update these criteria every five years. These addenda
represent an updated literature search current as of 1988, plus additional
Information from Agency files and Program Office.** The first draft of this
addendum was prepared by Syracuse Research Corporation under contract no.
68-C8-0004.
111
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TABLE OF CONTENTS
Page
INTRODUCTION 1
REVIEW OF NEW DATA 4
Toxlcologk/Carclnogenk Effects 4
BtpconcentraUon Factor (BCF) 6
QUANTIFICATION OF EFFECTS 7
EXISTING STANDARDS AND CRITERIA 9
REFERENCES 10
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LIST OF ABBREVIATIONS
ADI Acceptable dany Intake
BCF file-concentration factor
ECG Electrocardiogram
GOT Glutamlc oxaloaceUc transamlnase
GPT Glutamlc pyruvlc transamlnase
LOAEL Lowest-observed-adverse-effect level
LOEL Lowest-observed-effect level
NOAEL No-observed-adverse-effect level
ppm Parts per million
RfD Reference dose
RQ Reportable quantity
SNARL Suggested no-adverse response level
TLV Threshold limit value
TWA Time-weighted average
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INTRODUCTION
Under Section 304(a)(l) of the Clean Water Act of 1977 as amended In
1987, the U.S. EPA Is required to publish criteria for water quality
accurately reflecting the latest scientific knowledge regarding the effects
on health and welfare that may occur from the presence of pollutants In any
body of water, Including groundwater. In accordance *Uh the 1977 act,
Ambient Water Quality Criteria Documents (AWQCDs) were developed In 1980 for
65 toxic pollutants or classes of pollutants listed under Section 307(a)(l).
These addenda are Intended to serve as an update of the original AWQCDs.
The addenda provide the Agency with the latest scientific assessments of
potential health hazards associated with these pollutants and serve as
guidelines for modifying the current (1980) AWQCDs.
The human health criteria In these addenda are based on Agency verified
risk assessment values when available. These values consist of reference
doses (RfD) for those chemicals believed to be systemic toxicants (I.e., do
not Induce cancer) and cancer risk factors for those thought likely to cause
cancer In humans. The verification process consists of a review and con-
sensus of risk assessment values provided by an Agency workgroup consisting
of scientists from each of the major Agency offices. Assessments for
noncarclnogens are verified by the RfD workgroup and those for carcinogens
are verified by the Carcinogen Risk Assessment Verification Endeavor (CRAVE)
workgroup. If such values are not available, the criteria are based on the
most recent Agency health assessment. In the absence of any appropriate
Agency value, RfD values or cancer risk factors are derived by current
Agency methods If adequate new data are available, and criteria are recom-
mended based on the proposed RfD or risk factor.
2079A -1- 05/12/89
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The RfD Is an estimate (with uncertainty spanning perhaps an order of
magnitude) of the dally exposure to the human population (Including
sensitive subgroups) that Is likely to be without an appreciable risk of
deleterious effects during a lifetime, The RfD Is derived by dividing a
NOAEL or LOAEL for subchronlc or chronic exposure by standard uncertainty
factor(s) times an additional uncertainty factor:
RfD m NOAEL or LOAEL
UF(s) x UF
The standard uncertainty factors are applied to reflect the various types of
data used to estimate RfOs. An uncertainty factor of 10 Is used to account
for variations In human sensitivity when extrapolating from valid human
studies Involving long-term exposure of average, healthy subjects. An
additional 10-fold factor Is used for each of the following: to extrapolate
from long-term animal studies to the case of humans, to extrapolate from
subchronlc animal studies to chronic exposure, and to extrapolate from a
LOAEL to a NOAEL. An additional uncertainty factor of >0-10 may be applied
to reflect professional assessment of the uncertainties of the study and
data base not explicitly addressed by the standard uncertainty factors
(I.e., completeness of the overall data base). The default value for the
additional uncertainty factor Is 1.
In assessing the carcinogenic potential of a chemical, the U.S. EPA
classifies the chemical Into one of the following groups according to the
degree of evidence In ep1dem1olog1cal studies and animal studies: Group A -
Human Carcinogen; Group B - Probable Human Carcinogen [limited evidence In
humans with or without sufficient evidence 1n animals (Group Bl) or Inade-
quate evidence In humans with sufficient evidence 1n animals (Group 62)];
Group C - Possible Human Carcinogen (limited evidence of carclnogenUHy In
animals In the absence of human data); Group D - Not Classifiable as to
2079A -2- 05/12/89
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Human Carctnogentclty (Inadequate or no evidence); Group E - Evl^nce of
Noncarclnogenlclty for Humans, Quantitative carcinogenic risk assessments
are performed for chemicals In Groups A and B, and on a case-by-case basis
for chemicals In Group C. Upper-bound cancer unit risks (slope values) are
estimated through the use of mathematical extrapolation models. Most
commonly for animal data, the linearized multistage model with a 95X upper
confidence limit Is used to provide a low-dose estimate of cancer risk. The
cancer risk Is characterlred as an upper-limit estimate (I.e.. the true risk
to humans, while not Identifiable, Is not likely to exceed the upper-limit
estimate and In fact may be lower). Alternative risk models to the multi-
stage model, such as the one-hit, Welbull, Loglt or Problt model, are
available and may be used when the evidence Indicates that they may be more
appropriate. In the absence of such evidence, the Agency recommends the
linearized multistage model to provide consistency of approach and an
upper-bound on the potential carcinogenic risk. In the case where human
data are used for quantitative risk assessment, an upper-bound estimate
rather than a 95X upper-bound estimate Is used when low-dose linearity 1s
assumed.
In the development of this Addendum to the AWQCD on antimony, recent
Agency assessments have been consulted. A computerized literature search
was conducted to cover studies published more recently than the latest
Agency assessment (I.e., published In 1985 to 1988). New key studies have
been evaluated.
2079A -3- 05/12/89
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REVIEW OF NEW DATA
Tox1coloQlc/Carc1noQ»n1g
Female normotenslve (not otherwise specified) albino rats (30/group)
were administered antimony trichloride at 0, 0,1 or 1 mg/dl (0, 1 or 10
ppm) In drinking water from the 1st day of pregnancy until weaning of the
pups (22 days after delivery) to evaluate the effect of antimony on
development of vascular reactivity 1n the pups (Rossi et al., 1987). The
pups (10/dam) received antimony trichloride at 0, 1 or 10 ppm In their
drinking water from weaning to day 60. The dams showed a dose-related
significant (p<0.05) decrease 1n body weight on day 20, but not day 10 of
gestation. There were no significant (p<0.05) changes In maternal or
offspring systolic arterial blood pressure, length of gestation or number of
pups/Utter. The pups 1n the high-dose group had significantly (p<0.05)
reduced body weight from days 10-60, but showed no macroscopic teratogenlc
effects. Pre- and postnatal exposure to antimony trichloride did not
slgnlflcanty (p<0.05) affect pressor response to transient carotid artery
occlusion. Pressor response of 60-day-old pups to 1-noradrenalln and
l-1soprena!1ne (hypertension-Inducing drugs) was significantly (p<0/05)
decreased In both antimony trichloride-treated groups compared with
untreated controls, and response to acetylchollne (hypotension-Inducing) was
significantly (p<0.05) decreased only In the high-dose pups at 60 days.
In another study, male Wlstar rats were divided among one control and
three treated groups (Hlraoka. 1986). The treated groups were fed diets
containing 0.1X (w/w) metal antimony, l.OX (w/w) antimony or 1.0% antimony
trloxlde for 12 weeks (0, 0.1X, l.OX or l.OX antimony). The rats were
evaluated at 0, 4 and 12 weeks post-exposure for body weight gain, organ
weights, hematologUa-1 and limited blood biochemical endpolnts. There were
no effects on behavior, general appearance, blood hemoglobin concentration,
2079A -4- 09/20/88
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GOT activities or A:G ratio. Elevated GPT and decreased hematocrlt and
total blood protein were observed In rats fed the diet containing IX
metallic antimony <4 weeks after exposure. Body weights of rats fed diets
containing IX metallic antimony and IX antimony trloxlde were depressed
after 12 weeks of exposure, but not after the 12-week recovery period. The
abstract stated that some significant changes In organ weights (not
specified) were observed 1n antimony treated rats, however the complete
paper was not available for review.
The carclnogenlclty of antimony was recently reviewed by U.S. EPA
(1987a). A briefly reported retrospective ep1dem1olog1cal study of antimony
process workers associated lung cancer with occupational exposure to
antimony (Davles, 1973). Schroeder et al. (1970) provided Long-Evans rats
with drinking water containing 5 ppm antimony (sae next section) and
Kanlsawa and Schroeder (1969) provided CD-I (male and female) mice with
drinking water containing 5 ppm antimony 1n lifetime studies and concluded
that neither rats nor mice exhibited a carcinogenic response. In an Inhala-
tion study (ASARCO, Inc., 1980; Watt, 1980, 1981, 1983), a statistically
significant Increase In the Incidence of lung tumors was observed In female
Sprague-Dawley rats Intermittently exposed to antimony from antimony trl-
oxlde at 4.2 mg/m3 but not at 1.6 mg/m3. The data were not sufficient
for quantitative estimation of carcinogenic potency, but antimony was
assigned to EPA Group B2: probable human carcinogen (U.S. EPA, 1987a).
Current data are Inadequate to assess the potential carclnogenlclty of
ingested antimony.
2079A -5- 05/12/89
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Bloeoncentratlon Factor
The BCF value of 1 determined In U,S, EPA (1980) was reevaluated 1n
Stephan (1983). A new BCF of 0,5 was derived, Pertinent new Information
regarding the BCF value for antimony Is currently undergoing Agency review.
The BCF value of 0.5 {Stephan, 1983) will be used until this evaluation has
been completed.
2079A -6- 05/12/89
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QUANTIFICATION OF EFFECTS
The 1980 ambient water quality criteria (U.S. EPA, 1980) for human
health for antimony were based on a lifetime study 1n which groups of at
least 50 male and 50 female Long-Evans rats were provided drinking water
containing antimony at 0 or 5 ppm from antimony potassium tartrate
(Schroeder et al., 1970). Endpolnts monitored Included mortality, body
weights, blood pressure, serum chemistries Including glucose, urlnalysls and
tumor Incidence. Rats that died during the study were necropsled and gross
lesions were examined hlstopathologlcally. Treated rats of both sexes had
significantly decreased survival and decreased nonfastlng serum glucose,
compared with controls. Treated males had elevated serum cholesterol and
treated females had decreased serum cholesterol. The 5 ppm antimony level
was. designated a LOEL, but was considered to be close to the NOAEL. U.S.
EPA (1980) estimated that the rats weighed 0.3 kg, assumed a drinking water
consumption value of 0.025 I/day and applied an uncertainty factor rf 100
(10 for Inter- and 10 for Intraspecles variation) to derive an ADI for
antimony of 4.17 yg/kg/day. Assuming a human body weight of 70 kg, dally
drinking water consumption of 2 I/day, dally fish and shellfish consump-
tion of 0.0065 kg/day and a BCF of 1, U.S. EPA (1980) derived water criteria
of 145 yg/l for consumption of water and fish and shellfish and 45
mg/l for consumption of fish and shellfish alone.
The Schroeder et al. (1970) study was also used as the basis for the
verified RfD currently on IRIS (U.S. EPA. 1985a). In the RfD derivation.
the 5 ppm concentration was equivalent to a dosage of 0.35 mg/kg/day based
on an estimation of drinking water consumption. Although Schroeder et al.
(1970) did not calculate a dosage for antimony, U.S. EPA (1987a) noted that
^079A -7- 05/12/89
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another report from this laboratory (Kanlsawa and Schroeder, 1969) provided
an estimate of drinking water consumption by rats In parallel studies from
which the dosage of 0,35 mg/kg/day can be estimated. Application of an
uncertainty factor of 1000 (10 for Interspecles variation, 10 for Intra-
specles variation and 10 to estimate a NOAEL from a LOAEL) resulted In an
RfD of 0.00035 mg/kg/day, which was rounded to 0,0004 mg/kg/day. Applying
the assumptions discussed above, and the BCF of 0.5 derived In Stephan
(1983), new ambient water quality criteria of 14 yg/l for consumption of
water, fish and shellfish and 8.6 mg/l for consumption of fish and
shellfish alone can be derived.
A more recent paper by Rossi et al. (1987) Identified a dose-related
reduction In body weight gain In dams exposed to 1 and 10 ppm antimony
trichloride In drinking water throughout gestation. In addition, high-dose
pups had reduced body weights and the response of pups to hyper- and
hypotension-Inducing drugs was altered. Because food and water consumption
data were not provided, U was not possible to determine If the effects on
body weight reflect toxlclty of the chemical or reduced food and/or water
Intake. Using a formula for estimating drinking water consumption (0.049
l/day) for rats weighing 350 g (U.S. EPA, 1986), dosages of antimony
trichloride of 0.14 and 1.4 mg/kg/day can be estimated. Corresponding
dosages of antimony are 0.07 and 0.75 mg/kg/day. These data suggest an
effect on body weights at dosages lower than that used by Schroeder et al.
(1970) In which there were no effects on body weight In a much longer
study. It Is possible that antimony trichloride Is more toxic to rats than
antimony potassium tartrate. Additional studies may be warranted In order
to clarify this effect level.
20l(9A -8- 05/12/89
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EXISTING STANDARDS AND CRITERIA
NAS (1980) determined that data were Insufficient for derivation of
1-day, 7-day or chronic SNARLS for antimony. U.S. EPA (1987b) listed
antimony as a contaminant In drinking water required to be regulated by the
1986 amendments to the Safe Drinking Water Act; however, regulations are not
yet available.
Arzamastsev (1964) determined the taste threshold for either trlvalent
or pentavalent antimony at 0.6 mg/i.
The ACGIH (1987) TLV-THA recommendation, OSHA (1985) standard and NIOSH
(1978) criteria are all set at 0.5 mg/m». ACGIH (1986) stated that the
TLV should protect against ECG effects, dermatitis. Irritation of the mucous
membranes and pneumoconlosls.
The final RQ for release Into the environment 1s 5000 pounds (U.S. EPA,
1988).
207?A -9- 09/20/88
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REFERENCES
ACG1H (American Conference of Governmental Industrial Hyglenlsts). 1986.
Documentation of the Threshold Limit Values and Biological Exposure Indices,
5th ed. Cincinnati, OH. p. 32-33.
ACGIH (American Conference of Governmental Industrial Hyglenlsts). 1987.
V
Threshold Limit Values and Biological Exposure Indices for 1987-1988.
Cincinnati. OH. p. 12.
Arzamastsev. E.V. 1964. Experimental substantiation of the permissible
concentrations of tr1- and pentavalent antimony In water bodies. Hyg.
Sanlt. (Transl. G1g. SanU.). 29: 16-21. (Cited In NAS. 1980)
ASARCO, Inc. 1980, TSCA 8(e) submission 8EHQ-0580-0342. Blo/tox data on
antimony trloxlde. OTS, U.S. EPA. Washington. DC. (Cited In U.S. EPA,
1987a)
Davles, T.A.L. 1973. The health of workers engaged In antimony oxide
manufacture -- A statement. Dept. Employment, Employment Hedlcal Advisory
Serv., London. 2 p. (CUed 1n U.S. EPA, 1987a)
Hlraoka, N. 1986. The toxldty and organ-distribution of antimony after
chronic administration to rats. J. Kyoto Prefect Univ. Ned. 95(8):
997-1017. (Jap.) (Taken from Blol. Abstr. 86: 36186)
2079A -10- 09/20/88
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Kanlsawa, H. and H.A, Schroeder. 1969, Life term studies on the effects of
trace elements on spontaneous tumors In mice and rats. Cancer Res. 29:
892-895. (Cited In U.S. EPA, 19B7a)
HAS (National Academy of Sciences). 1980. Drinking Water and Health.
Vol. 3. MAS, Washington, DC. p. 77-80.
NIOSH (National Institute for Occupational Safety and Health). 1978.
Criteria for a Recommended Standard...Occupational Exposure to Antimony.
DHEW Publ. No. (NIOSH) 78-216. (CHed 1n U.S. EPA, 1985b)
OSHA (Occupational Safety and Health Administration). 1985. Occupational
Standards Permissible Exposure Limits. 29 CFR 1910.1000.
Rossi, F., R. Acampora, C. Vacca, et al. 1987. Prenatal and postnatal
antimony exposure In rats: effect on vasomotor reactivity development of
pups. Teratogen. Carclnog. Hutagen. 7: 491-496.
Schroeder, H.A., MUchner, H. and Nason, A.P. 1970. Zirconium, nlobllum,
antimony and lead In rats: Life-time studies. J. Nutr. 100: 59-69.
Stephan, C.E. 1983. Memorandum to Randall J. Bruins.
U.S. EPA. 1980. Ambient Water Quality Criteria Document for Antimony.
Prepared by the Office of Health and Environmental Assessment, Environmental
Criteria and Assessment Office, Cincinnati, OH for the Office of Water Regu-
lations and Standards,.Washington DC. EPA 440/5-80-020. NTIS PB81-117319.
?079A -11- 09/20/88
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U.S. EPA. 1985a. Integrated Risk Information System (IRIS): Reference Dose
(RfD) for Oral Exposure for Antimony, Online, (Revised; Verification date
n .'06/85.) Office of Health and Environmental Assessment, Environmental
Criteria and Assessment Office, Cincinnati, OH,
U.S. EPA. 1985b. Health and Environmental Effects Profile for Antimony
Oxides. Prepared by the Office of Health and Environmental Assessment,
Environmental Criteria and Assessment Office, Cincinnati, OH for the Office
of Solid Waste and Emergency Response, Washington, DC. EPA/600/X-85/271.
NTIS PB88-175039/AS.
U.S. EPA. 1986. Reference Values for Risk Assessment. Prepared by the
Office of Health and Environmental Assessment, Environmental Criteria and
Assessment Office, Cincinnati, OH for the Office of Solid Waste, Washington
DC.
U.S. EPA. 1987a. Health Effects Assessment for Antimony and Compounds.
Prepared by the Office of Health and Environmental Assessment, Environmental
Criteria and Assessment Office, Cincinnati, OH for the Office of Emergency
and Remedial Response, Washington, DC. EPA/600/8-88/018. NTIS
t
PB88-179445/AS.
U.S. EPA. 1987b. 40 CFR 141 Drinking water; Substitution of Contaminants
and Priority List of Additional Substances Which May Require Regulation
Under the Safe Drinking Water Act. Federal Register. 52(130): 25720-25734.
2079A -12- 09/20/88
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U.S. EPA. 1988. Integrated Risk Information System (IRIS). Chemical File
for Antimony. Online. Office of Health and Environmental Assessment,
Environmental Criteria and Assessment Office, Cincinnati, OH.
Watt, W.D. 1980. Chronic Inhalation toxldty of antimony trloxlde and
validation of the TLV. Progress report — Summary of results. TSCA 8(e)
submission. 8#HQ-0980-0342. Study submitted by ASARCO, Inc., New York.
Microfiche No. OTS020486. (Cited In U.S. EPA, 1987a)
Watt. W.O. 1981. FYI submission TY-OTS-00081-0121 regarding pathology
report on rat Inhalation study on antimony trloxlde. OTS, U.S. EPA,
Washington, DC. (Cited In U.S. EPA, 1987a)
Watt, W.D. 1983. Chronic Inhalation toxlclty of antimony trloxlde: Valida-
tion of the threshold limit value. Olss. Abstr. Int. B. 44(3): 739-740.
(Cited In U.S. EPA, 1987a)
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