United States Environmental Protection 1=1 m m Agency EPA/690/R-10/006F Final 9-29-2010 Provisional Peer-Reviewed Toxicity Values for Coronene (CASRN 191-07-1) Superfund Health Risk Technical Support Center National Center for Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Cincinnati, OH 45268 ------- AUTHORS, CONTRIBUTORS, AND REVIEWERS CHEMICAL MANAGER Jon Reid, Ph.D., DABT 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) ------- 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 WOE DESCRIPTOR 3 MODE-OF-ACTION DISCUSSION 3 REFERENCES 4 l Coronene ------- 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 11 Coronene ------- FINAL 9-20-2010 PROVISIONAL PEER-REVIEWED TOXICITY VALUES FOR CORONENE (CASRN 191-07-1) 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. 1 Coronene ------- FINAL 9-20-2010 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 coronene is included on the EPA's IRIS database (U.S. EPA, 2010) or on the Drinking Water Standards and Health Advisories List (U.S. EPA, 2006). The HEAST reported no RfD or RfC values (U.S. EPA, 2003). The Chemical Assessments and Related Activities (CARA) list (U.S. EPA, 1991, 1994) included a Health and Environmental Effects Profile (HEEP) for coronene (U.S. EPA, 1985) that declined to derive noncancer toxicity values due to inadequate noncancer data and potential carcinogenicity of the chemical. The toxicity of coronene has not been reviewed by ATSDR (2008) or the World Health Organization (WHO, 2010). CalEPA (2008) has not derived toxicity values for exposure to coronene. No occupational exposure limits for coronene 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 a cancer weight-of-evidence (WOE) classification or an oral slope factor for coronene. Coronene has not been evaluated under the 2005 Guidelines for Carcinogen Risk Assessment (U.S. EPA, 2005). The International Agency for Research on Cancer (IARC, 1983) lists coronene as Not Classifiable as to its Carcinogenicity to Humans because of inadequate data. Coronene is not included in the 11th Report on Carcinogens (NTP, 2005). CalEPA (2002) has not prepared a quantitative estimate of carcinogenic potential for coronene. Literature searches were conducted on sources published from 1900 through April 2010, for studies relevant to the derivation of provisional toxicity values for coronene, CAS No. 191-07-1. Searches were conducted using EPA's Health and Environmental Research Online (HERO) evergreen 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: 2 Coronene ------- FINAL 9-20-2010 Academic Search Complete; GeoRef Preview; GPO: Government Printing Office; Informaworld; IngentaConnect; J-STAGE: Japan Science & Technology; JSTOR: Mathematics & 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, and TRI; 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 toxicity 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 coronene. DERIVATION OF PROVISIONAL VALUES Limitations in the available data preclude development of both cancer and noncancer toxicity values. CANCER WOE DESCRIPTOR Limitations in the available data preclude development of a WOE descriptor. MODE-OF-ACTION DISCUSSION Limitations in the available data preclude determination of a mode-of-action discussion. 3 Coronene ------- FINAL 9-20-2010 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.eov/cgi-bin/sis/htmlgen7HSDB. Accessed on 4/26/2010. 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/toxpro2.html. Accessed on 4/26/2010. CalEPA (California Environmental Protection Agency). (2002) Office of Environmental Health Hazard Assessment. Hot Spots Unit Risk and Cancer Potency Values. Available online at http://www.oehha.ca.gov/air/hot spots/pdf/TSDlookup2002.pdf and http://www.oehha.ca.gov/air/hot spots/pdf/Appendix%20I2002.pdf. Accessed on 4/26/2010. CalEPA (California Environmental Protection Agency). (2008) Office of Environmental Health Hazard Assessment. Search Chronic RELs. Available online at http ://www. arb. ca. gov/toxics/healthval/chronic.pdf and http://www.oehha.ca.gov/air/chronic rets/AllChrels.html. Accessed on 4/26/2010. IARC (International Agency for Research on Cancer). (1983) IARC Monographs on the evaluation of carcinogenic risks to humans. Available online at http://monographs.iarc.fr/ENG/Monographs/vol32/volume32.pdf. Accessed on 4/26/2010. NIOSH (National Institute for Occupational Safety and Health). (2005) NIOSH Pocket Guide to Chemical Hazards. Index by CASRN. Available online at http://www.cdc.gov/niosh/npg/npgdcas.html. Accessed on 4/26/2010. 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.ni ehs.nih.gov/?obi ectid=7DA86165-BDB5- 82F8-F7E4FB36737253D5. Accessed on 4/26/2010. OSHA (Occupational Safety and Health Administration). (2010) OSHA Standard 1915.1000 for Air Contaminants. Part Z, Toxic and Hazardous Substances. Available online at http://www.osha.gov/pls/oshaweb/owadisp.show document?p table STAN'DARDS&p id=102 86. Accessed on 4/26/2010. U.S. EPA (U.S. Environmental Protection Agency). (1985) Health and Environmental Effects Profile (HEEP) for coronene. Environmental Criteria and Assessment Office, Cincinnati, OH; ECAO-CIN-P147. September. U.S. EPA (U.S. Environmental Protection Agency). (1986) Guidelines for carcinogen risk assessment. Prepared by the Risk Assessment Forum, U.S. Environmental Protection Agency, Washington, DC. 4 Coronene ------- FINAL 9-20-2010 U.S. EPA (U.S. Environmental Protection Agency). (1991) Chemical Assessments and Related Activities (CARA). Office of Health and Environmental Assessment, Washington, DC. U.S. EPA (U.S. Environmental Protection Agency). (1994) Chemical Assessments and Related Activities (CARA). Office of Health and Environmental Assessment, Washington, DC. December. U.S. EPA (U.S. 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-h.east.oml.gov/. Accessed 4/26/2010. U.S. EPA (U.S. Environmental Protection Agency). (2005) Guidelines for carcinogen risk assessment. Risk Assessment Forum, Washington, DC; EPA/630/P-03/001F. Federal Register 70(66): 17765-17817. U.S. EPA (U.S. Environmental Protection Agency). (2006) 2006 Edition of the Drinking Water Standards and Health Advisories. Office of Water, Washington, DC; EPA 822-R-06-013. Available online at http://www.epa.gov/waterscience/drinking/standards/dwstandards.pdf. Accessed 4/26/2010. U.S. EPA (U.S. 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 4/26/2010. 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 4/26/2010. 5 Coronene ------- |