TECHNICAL REPORT DATA
(ftettt md iiuttctioas on the nvmt before compieringj
1. REPOHTNO.
EPA/600/8-88/060
2.
3. RECIPIENT'S ACCESSION NO.
PB88-178801/AS
4. TITLE AND SUBTITLE
Health Effects Assessment for Trimethylbenzenes
5. REPORT DATE
«. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
I. PERFORMING ORGANIZATION REPORT NO
9. PERFORMING ORGANIZATION NAME AND ADDRESS
10. PROGRAM ELEMENT NO.
11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME ANO ADDRESS
13. TYPE OF REPORT ANO PERIOD COVERED
Environmental Criteria and Assessment Office
Office of Research and Development
U.S. Environmental Protection Agency
Cincinnati. OH 45268
14. SPONSORING AGENCY CODE
EPA/600/22
IS. SUPPLEMENTARY NOTES
6. ABSTRACT
This report summarizes and evaluates information relevant to a preliminary interim
assessment of adverse health effects associated with specific chemicals or compounds.
The Office of Emergency and Remedial Response (Superfund) uses these documents in
preparing cost-benefit analyses under Executive Order 12991 for decision-making under
CERCLA. All estimates of acceptable intakes and carcinogenic potency presented in
this document should be considered as preliminary and reflect limited resources
allocated to this project. The intent in these assessments is to suggest acceptable
exposure levels whenever sufficient data are available. The interim values presented
reflect the relative degree of hazard associated with exposure or risk to the
chemical(s) addressed. Whenever possible, two categories of values have been
estimated for systemic toxicants (toxicants for which cancer is not the endpoint of
concern). The first, RfDs or subchronic reference dose, is an estimate of an exposure
level that would not be expected to cause adverse effects when exposure occurs during
a limited time interval. The RfD is an estimate of an exposure level that would not
be expected to cause adverse effects when exposure occurs for a significant portion
of the lifespan. For compounds for which there is sufficient evidence of
carcinogenicity, qi*s have been computed, if appropriate, based on oral and
inhalation data if available.
7.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b.IDENTIFIERS/OPEN ENDED TERMS
c. COSATI Field/Croup
8. DISTRIBUTION STATEMENT
Public
19. SECURITY CLASS (This Report)
Unclassified
21. NO. OF PAGES
20. SECURITY CLASS (This page)
Unclassified
22. PRICE
EPA Form 2220-1 (R«». 4-77) PREVIOUS COITION IS OMOLtTC
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EPA/600/8-88/060
June, 1987
HEALTH EFFECTS ASSESSMENT
FOR TRIMETHYLBENZENES
ENVIRONMENTAL CRITERIA AND ASSESSMENT OFFICE
OFFICE OF HEALTH AND ENVIRONMENTAL ASSESSMENT
OFFICE OF RESEARCH AND DEVELOPMENT
U.S. ENVIRONMENTAL PROTECTION AGENCY
CINCINNATI, OH 45268
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DISCLAIMER
This document has been reviewed In accordance with the U.S.
Environmental Protection Agency's peer and administrative review policies
and approved for publication. Mention of trade names or commercial products
does not constitute endorsement or recommendation for use.
11
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PREFACE
This report summarizes and evaluates Information relevant to a prelimi-
nary Interim assessment of adverse health effects associated with trlmethyl-
benzenes. All estimates of acceptable Intake and carcinogenic potency
presented In this document should be considered as preliminary reflecting
limited resources allocated to this project. Pertinent toxlcologlc and
environmental data were located through on-line literature searches of the
TOXLINE and the CHEMFATE/DATALOG data bases. The basic literature searched
supporting this document Is current up to May, 1986. Secondary sources of
Information have also been relied upon In the preparation of this report and
represent large scale health assessment efforts that entail extensive peer
and Agency review.
The Intent In these assessments 1s to suggest acceptable exposure levels
for noncarclnogens and risk cancer potency estimates for carcinogens
whenever sufficient data were available. Values were not derived or larger
uncertainty factors were employed when the variable data were limited 1n
scope tending to generate conservative (I.e., protective) estimates.
Nevertheless, the Interim values presented reflect the relative degree of
hazard or risk associated with exposure to the chemlcal(s) addressed.
Whenever possible, two categories of values have been estimated for
systemic toxicants (toxicants for which cancer Is not the endpolnt of
concern). The first, RfD$ (formerly AIS) or subchronlc reference dose, Is
an estimate of an exposure level that would not be expected to cause adverse
effects when exposure occurs during a limited time Interval (I.e., for an
Interval that does not constitute a significant portion of the Hfespan).
This type of exposure estimate has not been extensively used, or rigorously
defined, as previous risk assessment efforts have been primarily directed
towards exposures from toxicants In ambient air or water where lifetime
exposure 1s assumed. Animal data used for RFD$ estimates generally
Include exposures with durations of 30-90 days. Subchronlc human data are
rarely available. Reported exposures are usually from chronic occupational
exposure situations or from reports of acute accidental exposure. These
values are developed for both Inhalation (RfD$i) and oral (RfO$o)
exposures.
The RfD (formerly AIC) 1s similar In concept and addresses chronic
exposure. It Is an estimate of an exposure level that would not be expected
to cause adverse effects when exposure occurs for a significant portion of
the Hfespan [see U.S. EPA (1980) for a discussion of this concept]. The
RfD Is route-specific and estimates acceptable exposure for either oral
(RfOg) or Inhalation (RfOi) with the Implicit assumption that exposure
by other routes 1s Insignificant.
111
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Compos He scores (CSs) for noncarclnogens have also been calculated
where data permitted. These values are used for Identifying reportable
quantities and the methodology for their development Is explained In U.S.
EPA (1983).
For compounds for which there Is sufficient evidence of carclnogenldty
RfOg and RfD values are not derived. For a discussion of risk assessment
methodology for carcinogens refer to U.S. EPA (1980). Since cancer Is a
process that Is not characterized by a threshold, any exposure contributes
an Increment of risk. For carcinogens, q-j*s have been computed, If appro-
priate, based on oral and Inhalation data 1f available.
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ABSTRACT
In order to place the risk assessment evaluation 1n proper context,
refer to the preface of this document. The preface outlines limitations
applicable to all documents of this series as well as the appropriate
Interpretation and use of the quantitative estimates presented.
Very few data were located regarding the toxlclty of the trlmethyl-
benzenes to either animals or humans. ACGIH (1980, 1985) recommended a TLV
of 25 ppm (-125 mg/m3) based on Inadequate animal and human data. How-
ever, lack of a pertinent toxlclty data base In support of the TLV precludes
the use of the TLV to derive an RfDg or RfDj. Data were riot sufficient
for computation of a CS.
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ACKNOWLEDGEMENTS
The Initial draft of this report was prepared by Syracuse Research
Corporation under Contract No. 68-03-3112 for EPA's Environmental Criteria
and Assessment Office, Cincinnati, OH. Dr. Christopher DeRosa and Karen
Blackburn were the Technical Project Monitors and John Helms (Office of
Toxic Substances) was the Project Officer. The final documents 1n this
series were prepared for the Office of Emergency and Remedial Response,
Washington, DC.
Scientists from the following U.S. EPA offices provided review comments
for this document series:
Environmental Criteria and Assessment Office, Cincinnati, OH
Carcinogen Assessment Group
Office of A1r Quality Planning and Standards
Office of Solid Waste
Office of Toxic Substances
Office of Drinking Water
Editorial review for the document series was provided by the following:
Judith Olsen and Erma Durden
Environmental Criteria and Assessment Office
Cincinnati, OH
Technical support services for the document series was provided by the
following:
Bette Zwayer, Jacky Bohanon and Kim Davidson
Environmental Criteria and Assessment Office
Cincinnati, OH
v1
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TABLE OF CONTENTS
1.
2.
3.
4.
5.
6.
7.
ENVIRONMENTAL CHEMISTRY AND FATE
ABSORPTION FACTORS IN HUMANS AND EXPERIMENTAL ANIMALS . . ,
2.1. ORAL
2.2. INHALATION
TOXICITY IN HUMANS AND EXPERIMENTAL ANIMALS
3.1. SUBCHRONIC
3.1.1. Oral
3.1.2. Inhalation
3.2. CHRONIC
3.2.1. Oral
3.2.2. Inhalation
3.3. TERATOGENICITY AND OTHER REPRODUCTIVE EFFECTS. . . .
3.4. TOXICANT INTERACTIONS
CARCINOGENICITY
4.1. HUMAN DATA
4.2. BIOASSAYS
4.3. OTHER RELEVANT DATA
4.4. HEIGHT OF EVIDENCE
REGULATORY STANDARDS AND CRITERIA
RISK ASSESSMENT
6.1. SUBCHRONIC REFERENCE DOSE (RfOs)
6.1.1. Oral (RfDso)
6.1.2. Inhalation (RfDSI)
6.2. REFERENCE DOSE (RfD)
6.2.1. Oral (RfD0) .
6.2.2. Inhalation (RfDj) . .
REFERENCES
Paqe
. . . 1
. . . 4
. . . 4
. . . 4
. . . 5
. . . 5
. . . 5
. . . 5
. . . 5
. . . 5
. . . 5
. . . 6
. . . 6
. . . 7
. . . 7
. . . 7
. . . 7
7
. . . 8
. . . 9
9
. . . 9
9
9
. . . 9
9
. . . 10
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LIST OF ABBREVIATIONS
BCF B1oconcentrat1on factor
CS Composite score
Koc Soil sorptlon coefficient
ppm Parts per million
RfD Reference dose
RfDj Inhalation reference dose
RfDg Oral reference dose
RfD$ Subchronlc reference dose
RfD$i Subchronlc Inhalation reference dose
RfD$o Subchronlc oral reference dose
SGOT Serum glutamlc oxaloacetlc transamlnase
STEL Short-term-exposure level
TLV Threshold limit value
WBC White blood cells
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1. ENVIRONMENTAL CHEMISTRY AND FATE
Selected chemical and physical properties of 1,2,3-trlmethylbenzene,
1,2,4-trlmethylbenzene and 1,3,5-trlmethylbenzene are listed In Table 1-1.
In the atmosphere the trlmethylbenzene compounds are expected to exist
primarily In the vapor phase. The atmospheric half-lives listed In Table
1-1 were calculated using measured HO radical reaction rate constants of
26.4xlO-12 cmVmolecule/sec for 1,2,3-trlmethylbenzene at 24°C,
33.5x10-" cm3/molecule-sec for 1,2,4-trlmethylbenzene at 23.8°C, and
47.2xlO-12 cmVmolecule-sec for 1,3,5-trlmethylbenzene at 24°C
(Atkinson, 1985) and assuming an ambient HO radical concentration of 10*
molecules/cm3.
In water, volatilization and blodegradatlon may be Important fate
processes for the trlmethylbenzenes (Hakeham et al., 1983). WHh respect to
volatilization, approximate residence times for 1,3,5-trlmethylbenzene 1n
water from Narragansett Bay, RI, were estimated to be 220 hours (Wakeham et
al., 1983). Zoeteman et al. (1980) estimated the half-life of 1,3,5-trl-
methylbenzene In Rhine River surface water (Netherlands) to be -1 day.
Based on recommended values for Henry's Law constant of 3.19xlO-3,
5.18xlO-3 and 5.92xlO-3 atm-mVmol at 25°C for 1,2,3-, 1,2,4,- and
1,3,5-trlmethylbenzene, respectively, volatilization half-lives from a body
of water 1 m deep flowing 1 m/sec with a wind speed of 3 m/sec were
calculated to be 3.6 hours for 1,2,3-trlmethylbenzene and 3.4 hours for
1,2,4- and 1,3,5-trimethylbenzene (Lyman et al., 1982; U.S. EPA, 1986b).
Estimated BCF and K values that suggest that bloaccumulat'ion In aquatic
organisms would be 1ns1gn1f1 ant and that moderate adsorption to suspended
solids and sediments may occur. The half-lives of the trlmethylbenzenes In
0095h -1- 12/31/86
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soil could not be located 1n the available literature. Based on aquatic
data, both vaporization and blodegradatlon are expected to play significant
roles In determining the half-lives of these compounds In soil; because of
their estimated K values, they are expected to be moderately mobile 1n
oc
soil (see Table 1-1).
0095h -3- 09/23/86
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2. ABSORPTION FACTORS IN HUMANS AND EXPERIMENTAL ANIMALS
2.1. ORAL
Gerarde (1959) reported that alkylbenzenes are "absorbed Into the blood
from the various portals of entry." In addition, the rate of absorption and
peak concentrations of aklylbenzenes In the blood appear to be porportlonal
to their solubility In water {Gerarde, 1959).
In a discussion of the comparative metabolism of 1,3,5-, 1,2,4- and
1,2,3-trlmethylbenzene, Mlkulskl and Hlglusz (1975) reported that 93.7,
62.6, and 56.6X of a single oral 1.2 g/kg dose of 1,3,5-, 1,2,4- and
1,2,3-trlmethylbenzene, respectively, was excreted as metabolites In the
urine of male Wlstar rats over a period of 3 days. These figures may not be
accurate estimates of absorption, since pulmonary, fecal, and biliary excre-
tion were not monitored. In general, alkylbenzenes are excreted unchanged
from the lung or as blotransformatlon products In the urine {Gerarde, 1959).
The data suggest, however, that absorption Is substantial following oral
administration.
2.2. INHALATION
Except for the general Information reported by Gerarde (1959), quantita-
tive data regarding the absorption of Inhaled tMmethylbenzenes could not be
located 1n the available literature.
0095h -4- 09/23/86
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3. TOXICITY IN HUMANS AND EXPERIMENTAL ANIMALS
3.1. SUBCHRONIC
3.1.1. Oral. Oral subchronlc studies regarding trlmethylbenzenes could
not be located 1n the available literature.
3.1.2. Inhalation. The only subchronlc Inhalation studies regarding
trlmethylbenzenes are abstracts from the foreign literature.
Bernshteln (1972) reported that phagocytlc activity of leukocytes was
Inhibited In rats after Inhalation of a mixture of trlmethylbenzenes (1
mg/i, 1000 mg/m3) 4 hours/day, 6 days/week for 6 months. This study
was summarized In Sandmeyer (1981); further details were not provided.
Hlglusz et al. (1975a,b.) reported "slight" alteration In differential
WBC count and elevated SGOT 1n male rats that had been exposed to 1,3,5-trl-
methylbenzene (3 mg/i, 3000 mg/m3) 6 hours/day, 6 days/week for 5 weeks.
No other details were reported.
3.2. CHRONIC
3.2.1. Oral. Pertinent data regarding chronic oral exposure to trl-
methylbenzenes could not be located 1n the available literature.
3.2.2. Inhalation. Battlg et al. (1957) reported symptoms of nervous-
ness, tension, anxiety and asthmatic bronchitis In a "significant number" of
27 people who worked for several years with "Fleet-x-DV-99," a solvent
containing 30% 1,3,5-trlmethylbenzene and SOX 1,2,4-trlmethylbenzene.
Tendencies toward hyperchromlc anemia and blood coagulation were also
observed among these Individuals. Concentration ranges for hydrocarbon
vapor ranged from 10-60 ppm. Gerarde (1960) speculated that ci small propor-
tion of benzene In the hydrocarbon vapor was probably responsible for the
hematologlc effects.
0095h -5- 12/31/86
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Pertinent data regarding the toxldty to animals of chronically Inhaled
tMmethylbenzenes could not be located 1n the available literature.
3.3. TERATOGENICITY AND OTHER REPRODUCTIVE EFFECTS
Pertinent data regarding the teratogenlclty or reproductive effects
associated with either Inhaled or Ingested trlmethylbenzenes could not be
located In the available literature.
3.4. TOXICANT INTERACTIONS
Benzene and Its methyl derivatives are metabolized to derivatives of
phenol and hlppurate. Oral administration of benzene along with either
1,2,3- or 1,3,5-trlmethylbenzene resulted 1n a higher concentration of
phenol In the blood than when benzene was administered alone. H1ppur1c add
levels 1n the blood were also elevated when benzene was administered
together with 1,2,3-trlmethylbenzene, but were decreased when benzene was
administered with 1,3,5-trlmethylbenzene (H1kulsk1 et al., 1979).
0095h -6- 09/23/86
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4. CARCINOGENICITY
4.1. HUMAN DATA
Pertinent data regarding the carclnogenldty of trlmethylbenzenes to
humans from oral or Inhalation exposure could not be located In the
available literature. Thus, trlmethylbenzenes are best classified 1n EPA
Group D, not classified (U.S. EPA, 1986).
4.2. BIOASSAYS
Pertinent data regarding oral or Inhalation cancer experiments In
animals could not be located In the available literature. Trlmethylbenzenes
have not been recommended for testing (NTP, 1986).
4.3. OTHER RELEVANT DATA
Other relevant data regarding the cardnogenldty or. mutagenlcHy of
trlmethylbenzenes could not be located 1n the available literature.
4.4. WEIGHT OF EVIDENCE
IARC has not evaluated the weight of evidence for carc'lnogenlclty to
humans of the trlmethylbenzenes; because data are Inadequate, an IARC
classification of Group 3 Is most appropriate. According to the EPA
guidelines for evaluating the weight of evidence (U.S. EPA, 1986), an EPA
classification of Group D (not classified) best reflects the lack of
carclnogenlclty test data.
0095h -7- 06/09/87
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5. REGULATORY STANDARDS AND CRITERIA
ACGIH (1980, 1985) recommended a TLV of 25 ppm (125 mg/m3) with a STEL
of 35 ppm (170 mg/m3) for occupational exposure to trlmethylbenzenes.
These recommendations were based on the study of Battlg et al. (1957) (see
Section 3.2.2.)« In this study, the workers were exposed to a solvent con-
taining a mixture of aromatic hydrocarbons (5054 pseudocumene, 30% mesltylene
and other hydrocarbons such as 1,2,3-trlmethylbenzene and 1-methyl-4-ethyl-
benzene). Since a pure chemical was not used In the study, a IOAEL cannot
be obtained. Therefore, a lifetime health advisory cannot be derived for
lack of data from adequate studies.
The Office of Toxic Substances (OTS) Is also recommending testing for
this chemical under TSCA Section 4 Test Rules at the present time.
0095h -8- 06/09/87
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6. RISK ASSESSMENT
6.1. SU8CHRONIC REFERENCE OOSE (RfD$)
6.1.1. Oral (RfOSQ). There are no data from which to derive an RfDSQ
for trlmethylbenzenes.
6.1.2. Inhalation (RfO.,). The subchronlc Inhalation data consist only
of three abstracts from the foreign literature (Bernshteln, 1972; Wlglusz et
al., 1975a,b). Each abstract reported only a single level of exposure at
which effects were seen. Information regarding the use of controls or other
levels of exposure was not provided. These studies are not adequate for
quantitative risk assessment.
6.2. REFERENCE DOSE (RfD)
6.2.1. Oral (RfD_). There are no data from which to derive an RfDQ
or CS for trlmethylbenzenes.
6.2.2. Inhalation (RfD,). There are no adequate subchronlc or chronic
Inhalation data that define dose-specific adverse effects; therefore, an
RfD, or a CS for trlmethylbenzene cannot be derived.
0095h -9- 06/09/87
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7. REFERENCES
ACGIH (American Conference of Governmental Industrial Hyglenlsts). 1980.
Documentation of the threshold limit values, 4th ed. Cincinnati, OH.
p. 415-416.
ACGIH (American Conference of Governmental Industrial Hyglenlsts). 1985.
TLVs: Threshold limit values and biological exposure Indices for 1985-1986.
Cincinnati, OH. p. 32.
Atkinson, R. 1985. Kinetics and mechanisms of the gas-phase reactions of
the hydroxyl radical with organic compounds under atmospheric conditions.
Chem. Rev. 85: 69-201.
Battlg, K., E. Grandjean and V. TurMan. 1957. No title provided. Z.
Prev. Med. 1: 389. (Cited 1n ACGIH, 1980)
Bernshteln, L.M. 1972. No title provided. Vopr. G1g. Tr. Profzabol.
Mater. Nauch. Konf. Vol. 53. (Cited In Sandmeyer, 1981)
Gerarde, H.W. 1959. lexicological studies on hydrocarbons, III. The
biochemistry of phenylalkanes and phenylalkenes. AMA Arch. Ind. Health.
19: 403-418.
Gerarde, H.W. 1960. Toxicology and biochemistry of aromatic hydrocarbons.
Elsevler Publishing Co., New York. p. 188-89. (Cited 1n ACGIH, 1980)
0095h -10- 06/09/87
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Hansch, C. and A.J. Leo. 198S. Medchem Project Issue Mo. 26. Pomona
College, Claremont, CA.
Lyman, W.J., VI.F. Reehl and O.H. Rosenblatt. 1982. Handbook of Chemical
Property Estimation Methods, Environmental Behavior of Organic Compounds.
McGraw-Hill Book Co., New York, p. 4-9, 5-5, 15-13, 15-21.
Mackay, D. and H.Y. Shlu. 1981. A critical review of Henry's law constants
for chemicals of environmental Interest. 3. Phys. Chem. Ref. Data. 19:
1175-1199.
M1kulsk1, P.I. and R. Wlglusz. 1975. The comparative metabolism of
mesHylene, pseudocumene, and hemlmellHene In rats. Toxlcol. Appl.
Pharmacol. 31: 21-31.
M1kulsk1, P., R. Wlslusz, E. Galuszko and G. Oelas. 1979. Reciprocal
metabolic effect of benzene and Us methyl derivatives 1n rats. I. Study \n_
vivo. Bull. Inst. Marlt. Trop. Med. Gdynia. 30(1): 77-78.
NTP (National Toxicology Program). 1986. Management Status Report.
6/10/86.
Sandmeyer, E.E. 1981. Aliphatic hydrocarbons. In.: Patty's Industrial
Hygiene and Toxicology, Vol. 3, G.D. Clayton and F.E. Clayton, Ed. John
Wiley and Sons, Inc., New York. p. 3300-3302.
0095h -11- 06/09/87
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IT.S. EPA. 1980. Guidelines and Methodology Used In the Preparation of
Health Effect Assessment Chapters of the Consent Decree Water Criteria
Documents. Federal Register. 45(231): 79347-79357.
U.S. EPA. 1983. Methodology and Guidelines for Reportable Quantity Deter-
minations Based on Chronic Tox1c1ty Data. 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.
U.S. EPA. 1986. Guidelines for Carcinogenic Risk Assessment. Federal
Register. 51(185): 33992-34003.
Wakeham, S.T., J.T. Goodwin and A.C. Davis. 1983. Distribution and fate of
volatile organic compounds In Narragansett Bay, Rhode Island. Can. J. Fish
Aq. Sc1. 40(2): 304-321.
Wlglusz, R., M. Klenltz, G. Delag, E. Gllauszko and P. Mlkulskl. 1975a.
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