if!; United States Environmental Protectioi if % Agency EPA/690/R-08/001F Final 7-30-2008 Provisional Peer Reviewed Toxicity Values for Acenaphthylene (CASRN 208-96-8) Superfund Health Risk Technical Support Center National Center for Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Cincinnati, OH 45268 ------- Acronyms and Abbreviations bw body weight cc cubic centimeters CD Caesarean Delivered CERCLA Comprehensive Environmental Response, Compensation and Liability Act of 1980 CNS central nervous system cu.m cubic meter DWEL Drinking Water Equivalent Level FEL frank-effect level FIFRA Federal Insecticide, Fungicide, and Rodenticide Act g grams GI gastrointestinal HEC human equivalent concentration Hgb hemoglobin i.m. intramuscular i.p. intraperitoneal IRIS Integrated Risk Information System IUR inhalation unit risk i.v. intravenous kg kilogram L liter LEL lowest-effect level LOAEL lowest-observed-adverse-effect level LOAEL(ADJ) LOAEL adjusted to continuous exposure duration LOAEL(HEC) LOAEL adjusted for dosimetric differences across species to a human m meter MCL maximum contaminant level MCLG maximum contaminant level goal MF modifying factor mg milligram mg/kg milligrams per kilogram mg/L milligrams per liter MRL minimal risk level MTD maximum tolerated dose MTL median threshold limit NAAQS National Ambient Air Quality Standards NOAEL no-ob served-adverse-effect level NOAEL(ADJ) NOAEL adjusted to continuous exposure duration NOAEL(HEC) 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 inhalation reference concentration 1 ------- p-RfD provisional oral reference dose PBPK physiologically based pharmacokinetic ppb parts per billion ppm parts per million PPRTV Provisional Peer Reviewed Toxicity Value RBC red blood cell(s) RCRA Resource Conservation and Recovery Act RDDR Regional deposited dose ratio (for the indicated lung region) REL relative exposure level RfC inhalation reference concentration RfD oral reference dose RGDR Regional gas dose ratio (for the indicated lung region) s.c. subcutaneous SCE sister chromatid exchange SDWA Safe Drinking Water Act sq.cm. square centimeters TSCA Toxic Substances Control Act UF uncertainty factor Hg microgram |j,mol micromoles voc volatile organic compound 11 ------- 7-30-2008 PROVISIONAL PEER REVIEWED TOXICITY VALUES FOR ACENAPHTHYLENE (CASRN 208-96-8) Background On December 5, 2003, the U.S. Environmental Protection Agency's (EPA's) 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 (PPRTV) 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 Integrated Risk Information System (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 two EPA scientists and external peer review by three independently selected scientific experts. PPRTVs differ from IRIS values in that PPRTVs do not receive the multi-program 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 five-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 manuscripts 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 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 ------- 7-30-2008 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 manuscript 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 IRIS (U.S. EPA, 2008) does not report an RfD or RfC for acenaphthylene. The HEAST (U.S. EPA, 1997) states that data are inadequate for quantitative risk assessment for acenaphthylene based on a Health and Environmental Assessment (HEA) for the chemical (U.S. EPA, 1987). The Drinking Water Standards and Health Advisory list does not include acenaphthylene (U.S. EPA, 2006); a Drinking Water Criteria Document for polycyclic aromatic hydrocarbons reported no oral data suitable for quantitative risk assessment (U.S. EPA, 1990). The CARA (U.S. EPA, 1991, 1994) lists only the previously mentioned HEA (U.S. EPA, 1987). ATSDR (2008) has not produced a Toxicological Profile for acenaphthylene, and the Toxicological Profile for polycyclic aromatic hydrocarbons (ATSDR, 1995) does not include oral MRLs for acenaphthylene. There is no Environmental Health Criteria Document available for acenaphthylene (WHO, 2008), and there are no oral or inhalation chronic, subchronic, or carcinogenicity studies on acenaphthylene in the Environmental Health Criteria Document for polycyclic aromatic hydrocarbons (PAH) (WHO, 1998). ACGIH (2007), OSHA (2008), and NIOSH (2008) have not established occupational health standards for acenaphthylene. On IRIS (U.S. EPA, 2008), acenaphthylene is assigned to cancer Weight-of-Evidence Group D "Not Classifiable as to Human Carcinogenicity" based on the unavailability of human data and inadequate animal data. The carcinogenicity of acenaphthylene has not been assessed by IARC (2008) or NTP (2005, 2008). The National Institute for Public Health and the Environment of the Netherlands (RIVM) (Baars et al., 2001) concluded that acenaphthylene is a suspected carcinogen and assigned an oral slope factor of 0.05 mg/kg-day that is based on a relative potency value for acenaphthylene of 0.01 (Kalberlah et al., 1995, as cited in WHO, 1998) compared to the oral slope factor of 0.0005 mg/kg-day for benzo[a]pyrene (Kroese et al., 1999). 2 ------- 7-30-2008 Literature searches were conducted from the 1960s through December 2007 for studies relevant to the derivation of provisional toxicity values for acenaphthylene. Databases searched include MEDLINE, TOXLINE (Special), BIOSIS, TSCATS/TSCATS 2, CCRIS, DART/ETIC, GENETOX, HSDB, RTECS, and Current Contents. This document has passed the STSC quality review and evaluation indicating that the quality is consistent with the SOPs and standards of the STSC and is suitable for use by registered users of the PPRTV system. FEASIBILITY OF DERIVING A PROVISIONAL RfD FOR ACENAPHTHYLENE The available data are inadequate to derive a p-RfD for acenaphthylene. No dose- response information pertinent to any target organs was available in the current database; thus, the database lacks a study that could serve as a suitable basis for derivation of a p-RfD for acenaphthylene. FEASIBILITY OF DERIVING A PROVISIONAL RfC FOR ACENAPHTHYLENE No inhalation toxicity data in humans or animals are identified; thus, no p-RfC could be derived for acenaphthylene. PROVISIONAL CARCINOGENICITY ASSESSMENT FOR ACENAPHTHYLENE Because of the lack of carcinogenic data in humans or animals, under the 2005 Guidelines for Carcinogen Risk Assessment (U.S. EPA, 2005), this PPRTV document classifies acenaphthylene as having "Inadequate Information to Assess Carcinogenic Potential FEASIBILITY OF DERIVING A PROVISIONAL ORAL SLOPE FACTOR OR INHALATION UNIT RISK FOR ACENAPHTHYLENE Neither a p-OSF nor a p-IUR is derived for acenaphthylene because of the lack of suitable oral or inhalation data in both humans and animals. REFERENCES ACGIH (American Conference of Governmental Industrial Hygienists). 2007. 2007 Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. ACGIH, Cincinnati, OH. 3 ------- 7-30-2008 ATSDR (Agency for Toxic Substances and Disease Registry). 1995. Toxicological Profile for Polycyclic Aromatic Hydrocarbons (PAHs). Update. U.S. Department of Health and Human Services, Public Health Service, Atlanta, GA. ATSDR (Agency for Toxic Substances and Disease Registry). 2008. Toxicological Profile Information Sheet. U.S. Department of Health and Human Services, Public Health Service. Online, http://www.atsdr.cdc.gov/toxpro2.html. Baars, A.J., P.J. Theelen, J.M. Janssen, M.E. van Apeldorn, M. Meijrink, L. Verdam, and M.J. Zeilmaker. 2001. Re-evaluation of Human-toxicological Maximum Permissible Risk Levels. RIVM Report 711701 025. National Institute of Public Health and the Environment: Bilthoven, The Netherlands. IARC (International Agency for Research on Cancer). 2008. Search IARC Monographs. Online. http://monographs.iarc.fr/ENG/Monographs/allmonos90.php. Kalberlah, F., N. Frijus-Plessen and M. Hassauer. 1995. [Toxicological criteria for the risk assessment of polyaromatic hydrocarbons (PAH) in existing chemicals. Part 1: The use of equivalency factors.] Altlasten-Spektrum, 5: 231-237 (in German). Kroese, E., J. Muller, G. Mohn, P. Dortant and P. Wester. 1999. Tumorigenic effects in Wistar rats orally administered benzo[a]pyrene for two years (gavage studies). Implications for human cancer risks associated with oral exposure to polycyclic aromatic hydrocarbons. RIVM Report no. 658603010. Bilthoven, Netherlands:National Institute of Public Health and the Environment. NIOSH (National Institute for Occupational Safety and Health). 2008. NIOSH Pocket Guide to Chemical Hazards. Index by CASRN. Available at http://www2.cdc.gov/nioshtic- 2/nioshtic2.htm. 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 at http://ntp-server.niehs.nih.gov. NTP (National Toxicology Program). 2008. Management Status Report. Online. http://ntp.niehs.nih.gov/index.cfm?obiectid=78CC7E4C-FlF6-975E-72940974DE301C3F. OSHA (Occupational Safety and Health Administration). 2008. OSHA Standard 1910.1000 Table Z-l. Part Z, Toxic and Hazardous Substances. Available at http://www.osha- slc.gov/OshStd data/1910 1000 TABLE Z-l.html. U.S. EPA. 1987. Health Effects Assessment for Acenaphthylene. Prepared by the Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Solid Waste and Emergency Response, Washington, DC. 4 ------- 7-30-2008 U.S. EPA. 1990. Drinking Water Criteria Document for Poly cyclic Aromatic Hydrocarbons (PAHs). Prepared by the Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Drinking Water, Washington, DC. U.S. EPA. 1991. Chemical Assessments and Related Activities (CARA). Office of Health and Environmental Assessment, Washington, DC. U.S. EPA. 1994. Chemical Assessments and Related Activities (CARA). Office of Health and Environmental Assessment, Washington, DC. December. U.S. EPA. 1997. Health Effects Assessment Summary Tables. FY-1997 Update. 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. July. EPA/540/R-97/036. NTIS PB97-921199. U.S. EPA. 2005. Guidelines for Carcinogen Risk Assessment. Risk Assessment Forum, Washington, DC; EPA/630/P-03/001F. Federal Register 70(66): 17765-17817. Available online at http://www.epa.gov/raf. U.S. EPA. 2006. 2006 Edition of the Drinking Water Standards and Health Advisories. Office of Water, Washington, DC. EPA 822-R-06-013. Washington, DC. http://www.epa.gov/waterscience/drinking/standards/dwstandards.pdf. U.S. EPA. 2008. Integrated Risk Information System (IRIS). Office of Research and Development, National Center for Environmental Assessment, Washington, DC. Online. http ://www. epa. gov/iri s/. WHO (World Health Organization). 1998. Environmental Health Criteria 202: selected non- heterocyclic polycyclic aromatic hydrocarbons. International Program on Chemical Safety, Geneva, Switzerland. WHO (World Health Organization). 2008. Online catalogs for the Environmental Health Criteria Series. Online. http://www.who.int/ipcs/publications/ehc/ehc alphabetical/en/index.html. 5 ------- |