United States
Environmental Protection
1=1 m m Agency
EPA/690/R-11/036F
Final
4-26-2011
Provisional Peer-Reviewed Toxicity Values for
ft-Methylcyclohexylamine
(CAS No. 100-60-7)
Superfund Health Risk Technical Support Center
National Center for Environmental Assessment
Office of Research and Development
U.S. Environmental Protection Agency
Cincinnati, OH 45268

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AUTHORS, CONTRIBUTORS, AND REVIEWERS
CHEMICAL MANAGER
Phillip Kaiser, PhD, National Center for Environmental Assessment, Cincinnati, OH
DRAFT DOCUMENT PREPARED BY
National Center for Environmental Assessment, Cincinnati, OH
This document was externally peer reviewed under contract to
Eastern Research Group, Inc.
110 Hartwell Avenue
Lexington, MA 02421-3136
Questions regarding the contents of this document may be directed to the U.S. EPA Office of
Research and Development's National Center for Environmental Assessment, Superfund Health
Risk Technical Support Center (513-569-7300).

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TABLE OF CONTENTS
COMMONLY USED ABBREVIATIONS	ii
BACKGROUND	1
HISTORY	1
DISCLAIMERS	1
QUESTIONS REGARDING PPRTVS	2
INTRODUCTION	2
REVIEW OF POTENTIALLY RELEVANT DATA (CANCER AND NONCANCER)	3
DERIVATION 01 PROVISIONAL VALUES	3
CANCER WEIGHT-OF-EVIDENCE (WOE) DESCRIPTOR	3
MODE-OF-ACTION (MOA) DISCUSSION	3
REFERENCES	3
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COMMONLY USED ABBREVIATIONS
BMC
benchmark concentration
BMD
benchmark dose
BMCL
benchmark concentration lower bound 95% confidence interval
BMDL
benchmark dose lower bound 95% confidence interval
HEC
human equivalent concentration
HED
human equivalent dose
IUR
inhalation unit risk
LOAEL
lowest-observed-adverse-effect level
LOAELadj
LOAEL adjusted to continuous exposure duration
LOAELhec
LOAEL adjusted for dosimetric differences across species to a human
NOAEL
no-ob served-adverse-effect level
NOAELadj
NOAEL adjusted to continuous exposure duration
NOAELhec
NOAEL adjusted for dosimetric differences across species to a human
NOEL
no-ob served-effect level
OSF
oral slope factor
p-IUR
provisional inhalation unit risk
p-OSF
provisional oral slope factor
p-RfC
provisional reference concentration (inhalation)
p-RfD
provisional reference dose (oral)
POD
point of departure
RfC
reference concentration (inhalation)
RfD
reference dose (oral)
UF
uncertainty factor
UFa
animal-to-human uncertainty factor
UFC
composite uncertainty factor
UFd
incomplete-to-complete database uncertainty factor
UFh
interhuman uncertainty factor
UFl
LOAEL-to-NOAEL uncertainty factor
UFS
subchronic-to-chronic uncertainty factor
WOE
weight of evidence
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PROVISIONAL PEER-REVIEWED TOXICITY VALUES FOR
ft-METHYLCYCLOHEXYLAMINE (CASRN 100-60-7)
BACKGROUND
HISTORY
On December 5, 2003, the U.S. Environmental Protection Agency's (EPA) Office of
Superfund Remediation and Technology Innovation (OSRTI) revised its hierarchy of human
health toxicity values for Superfund risk assessments, establishing the following three tiers as the
new hierarchy:
1)	EPA's Integrated Risk Information System (IRIS)
2)	Provisional Peer-Reviewed Toxicity Values (PPRTVs) used in EPA's Superfund
Program
3)	Other (peer-reviewed) toxicity values, including
~	Minimal Risk Levels produced by the Agency for Toxic Substances and Disease
Registry (ATSDR);
~	California Environmental Protection Agency (CalEPA) values; and
~	EPA Health Effects Assessment Summary Table (HEAST) values.
A PPRTV is defined as a toxicity value derived for use in the Superfund Program when
such a value is not available in EPA's IRIS. PPRTVs are developed according to a Standard
Operating Procedure (SOP) and are derived after a review of the relevant scientific literature
using the same methods, sources of data, and Agency guidance for value derivation generally
used by the EPA IRIS Program. All provisional toxicity values receive internal review by a
panel of six EPA scientists and external peer review by three independently selected scientific
experts. PPRTVs differ from IRIS values in that PPRTVs do not receive the multiprogram
consensus review provided for IRIS values. This is because IRIS values are generally intended
to be used in all EPA programs, while PPRTVs are developed specifically for the Superfund
Program.
Because new information becomes available and scientific methods improve over time,
PPRTVs are reviewed on a 5-year basis and updated into the active database. Once an IRIS
value for a specific chemical becomes available for Agency review, the analogous PPRTV for
that same chemical is retired. It should also be noted that some PPRTV documents conclude that
a PPRTV cannot be derived based on inadequate data.
DISCLAIMERS
Users of this document should first check to see if any IRIS values exist for the chemical
of concern before proceeding to use a PPRTV. If no IRIS value is available, staff in the regional
Superfund and Resource Conservation and Recovery Act (RCRA) program offices are advised to
carefully review the information provided in this document to ensure that the PPRTVs used are
appropriate for the types of exposures and circumstances at the Superfund site or RCRA facility
in question. PPRTVs are periodically updated; therefore, users should ensure that the values
contained in the PPRTV are current at the time of use.
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It is important to remember that a provisional value alone tells very little about the
adverse effects of a chemical or the quality of evidence on which the value is based. Therefore,
users are strongly encouraged to read the entire PPRTV document and understand the strengths
and limitations of the derived provisional values. PPRTVs are developed by the EPA Office of
Research and Development's National Center for Environmental Assessment, Superfund Health
Risk Technical Support Center for OSRTI. Other EPA programs or external parties who may
choose of their own initiative to use these PPRTVs are advised that Superfund resources will not
generally be used to respond to challenges of PPRTVs used in a context outside of the Superfund
Program.
QUESTIONS REGARDING PPRTVS
Questions regarding the contents of the PPRTVs and their appropriate use (e.g., on
chemicals not covered, or whether chemicals have pending IRIS toxicity values) may be directed
to the EPA Office of Research and Development's National Center for Environmental
Assessment, Superfund Health Risk Technical Support Center (513-569-7300), or OSRTI.
INTRODUCTION
No reference dose (RfD), reference concentration (RfC), or cancer assessment for
«-methylcyclohexylamine is included in the EPA's IRIS database (U.S. EPA, 2010) or on the
Drinking Water Standards and Health Advisories List (U.S. EPA, 2009). No RfD or RfC values
are reported in the HEAST (U.S. EPA, 2003). The Chemical Assessments and Related Activities
(CARA) list (U.S. EPA, 1994) does not include a Health and Environmental Effects Profile
(HEEP) for //-methylcyclohexylamine (U.S. EPA, 1985). The toxicity of
//-methylcyclohexylamine has not been reviewed by the ATSDR (2008) or the World Health
Organization (WHO, 2010). CalEPA (2008, 2009a,b) has not derived toxicity values for
exposure to //-methyl cyclohexyl amine. No occupational exposure limits for
//-methyl cyclohexyl amine have been derived by the American Conference of Governmental
Industrial Hygienists (ACGIH, 2010), the National Institute of Occupational Safety and Health
(NIOSH, 2005), or the Occupational Safety and Health Administration (OSHA, 2010).
The HEAST (U.S. EPA, 2003) does not report any values based on the U.S. EPA (1986)
cancer weight-of-evidence classification for //-methyl cyclohexyl amine. The International
Agency for Research on Cancer (IARC, 2010) has not reviewed the carcinogenic potential of
//-methyl cyclohexyl amine. //-Methyl cyclohexyl amine is not included in the 11th Report on
Carcinogens (NTP, 2005). CalEPA (2009c,d) has not prepared a quantitative estimate of
carcinogenic potential for //-methyl cyclohexyl amine.
Literature searches were conducted on sources published from 1900 through April 2011
for studies relevant to the derivation of provisional toxicity values for //-m et hy 1 cy cl oh ex y 1 am i n e,
CAS No. 100-60-7. Searches were conducted using EPA's Health and Environmental Research
Online (HERO) database of scientific literature. HERO searches the following databases:
AGRICOLA; American Chemical Society; BioOne; Cochrane Library; DOE: Energy
Information Administration, Information Bridge, and Energy Citations Database; EBSCO:
Academic Search Complete; GeoRef Preview; GPO: Government Printing Office;
Informaworld; IngentaConnect; J-STAGE: Japan Science & Technology; JSTOR: Mathematics
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& Statistics and Life Sciences; NSCEP/NEPIS (EPA publications available through the National
Service Center for Environmental Publications [NSCEP] and National Environmental
Publications Internet Site [NEPIS] database); PubMed: MEDLINE and CANCERLIT databases;
SAGE; Science Direct; Scirus; Scitopia; SpringerLink; TOXNET (Toxicology Data Network):
ANEUPL, CCRIS, ChemlDplus, CIS, CRISP, DART, EMIC, EPIDEM, ETICBACK, FEDRIP,
GENE-TOX, HAPAB, HEEP, HMTC, HSDB, IRIS, ITER, LactMed, Multi-Database Search,
NIOSH, NTIS, PESTAB, PPBIB, RISKLINE, TRI; and TSCATS; Virtual Health Library; Web
of Science (searches Current Content database among others); World Health Organization; and
Worldwide Science. The following databases outside of HERO were searched for risk
assessment values: ACGM, AT SDR, CalEPA, EPA IRIS, EPA HEAST, EPA HEEP, EPA OW,
EPA TSCATS/TSCATS2, NIOSH, NTP, OSHA, and RTECS.
REVIEW OF POTENTIALLY RELEVANT DATA
(CANCER AND NONCANCER)
The literature search revealed no human or animal studies (either acute, short term, or
chronic) for development of toxicity values for //-methylcyclohexylamine.
DERIVATION OF PROVISIONAL VALUES
Limitations in the available data preclude development of both cancer and noncancer
toxicity values for //-methyl cyclohexyl amine.
CANCER WEIGHT-OF-EVIDENCE (WOE) DESCRIPTOR
Limitations in the available data preclude development of a WOE descriptor.
MODE-OF-ACTION (MOA) DISCUSSION
Limitations in the available data preclude determination of a MOA discussion.
REFERENCES
ACGIH (American Conference of Governmental Industrial Hygienists). (2010) Threshold limit
values for chemical substances and physical agents and biological exposure indices. Cincinnati,
OH. As cited in HSDB (Hazardous Substances Data Bank). Available online at
http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen7HSDB. Accessed on April 14, 2010.
ATSDR (Agency for Toxic Substances and Disease Registry). (2008) Toxicological profile
information sheet. U.S. Department of Health and Human Services, Public Health Service.
Available online at http://www.atsdr.cdc.gov/toxprofiles/index.asp. Accessed on April 14, 2010.
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CalEPA (California Environmental Protection Agency). (2008) All OEHHA acute, 8-hour and
chronic reference exposure levels (chRELs) as of December 18, 2008. Sacramento: Office of
Environmental Health Hazard Assessment. Available online at
http://www.oehha.ca.gov/air/allrels.html. Accessed on April 14, 2010.
CalEPA (California Environmental Protection Agency). (2009) OEHHA toxicity criteria
database. Office of Environmental Health Hazard Assessment, Sacramento, CA. Available
online at http://www.oehha.ca.gov/riskAChemicalDB/index.asp. Accessed on April 14, 2010.
IARC (International Agency for Research on Cancer). (2010) IARC Monographs on the
evaluation of carcinogenic risks to humans. Available online at
http://monographs.iarc.fr/ENG/Monographs/PDFs/index.php. Accessed on April 14, 2010.
NIOSH (National Institute for Occupational Safety and Health). (2005) ) NIOSH pocket guide
to chemical hazards. Index of chemical abstracts service registry numbers (CAS No.). Atlanta,
Ga: Center for Disease Control and Prevention, U.S. Department of Health, Education and
Welfare. Available online at http://www.cdc.gov/niosh/npg/npgdcas.html. Accessed on April
14, 2010.
NTP (National Toxicology Program). (2005) 11th Report on carcinogens. U.S. Department of
Health and Human Services, Public Health Service, National Institutes of Health, Research
Triangle Park, NC. Available online at http://ntp-server.mehs.nih.gov/index.cfm?objectid=
32BA9724-F1F6-975E-7FCE50709CB4C932. Accessed on April 14,2010.
OSHA (Occupational Safety and Health Administration). (2010) OSHA (Occupational Safety
and Health Administration). (2010) Air contaminants: occupational safety and health standards
for shipyard employment, subpart Z, toxic and hazardous substances. U.S. Department of Labor,
Washington, DC. OSHA Standard 1915.1000. Available online at
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=102
86. Accessed on April 14, 2010.
U.S. EPA (Environmental Protection Agency). (1985) Health and environmental effects profile
(HEEP) for N-methyl cyclohexylamine. Environmental Criteria and Assessment Office,
Cincinnati, OH. ECAO-CIN-P147. September.
U.S. EPA (Environmental Protection Agency). (1986) Guidelines for carcinogen risk
assessment. Risk Assessment Forum, Washington, DC. EPA/630/R-00/004. September 1986.
Available online at http://epa.gov/raf/publications/pdfs/CA%20GUIDELINES_1986.PDF.
U.S. EPA (Environmental Protection Agency). (1994) Chemical assessments and related
activities (CARA). Office of Health and Environmental Assessment, Washington, DC.
EPA/600/R-94/904. Available online at nepis.epa.gov lixe ZyPl 11H..cgi?Dockey 6000/08Lfxf.
U.S. EPA (Environmental Protection Agency). (2003) Health effects assessment summary
tables (HEAST). Prepared by the Office of Research and Development, National Center for
Environmental Assessment, Cincinnati OH for the Office of Emergency and Remedial Response,
Washington, DC; EPA 540-R-97-036. Available online at http://epa-heast.ornl.gov/. Accessed
on April 14, 2010.
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U.S. EPA (Environmental Protection Agency). (2009) 2009 edition of the drinking water
standards and health advisories. Office of Water, Washington, DC; EPA/822/R-09/011.
Available online at
http://deq.state.wy.us/wqd/groundwater/downloads/dwstandards2009%5Bl%5D.pdf. Accessed
on April 14, 2010.
U.S. EPA (Environmental Protection Agency). (2010) Integrated risk information system
(IRIS). Office of Research and Development, National Center for Environmental Assessment,
Washington, DC. Available online at http://www.epa.gov/iris/. Accessed on April 14,2010.
WHO (World Health Organization). (2010) Online catalogs for the Environmental Health
Criteria Series. Available online at http://www.who.int/ipcs/publications/ehc/en/. Accessed on
April 14, 2010.
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