United States Environmental Protection Agency Environmental Criteria and Assessment Office Research Triangle Park NC 27711 Research and Development EPA-600/S8-82-002F Dec. 1983 Project Summary Health Assessment Document for 1,1,2-Trichloro- 1,2,2-Trif luoroethane (Chlorofluorocarbon CFC-113)- Final Report Richard Carchman and Mark M. Greenberg The Office of Health and Environmen- tal Assessment has prepared this health assessment to serve as a source docu- ment for EPA use. Originally the health assessment was developed for use by the Office of Air Quality Planning and Standards to support decision-making regarding possible regulation to chloro- fluorocarbon 113 (CFC-113} as a ha- zardous air pollutant. However, at the request of The Agency's Work Group on Solvents the assessment scope was ex- panded to address multimedia aspects. In the development of the assessment document, the scientific literature has been inventoried, key studies have been evaluated, and summary/conclusions have been prepared so that the toxicology of CFC-113 and the chemical's related characteristics are qualitatively identi- fied. Observed-effect levels and dose- response relationships are discussed, where appropriate, so that the nature of the adverse health responses are placed in perspective with observed environ- mental levels. This document evaluates health effects associated with exposure to CFC-113. CFC-113 is released into the environmental air as a result of evapora- tive loss during production storage, consumer use, and manufacturing use. In regard to potential health effects associated with CFC-113, there is no evidence indicating that human health effects are likely to occur at ambient air mixing ratios (e.g., 18 ppt; 0.14 x 10~3 mg/m3) found or expected in the general environment or even at higher levels «4. 160 ppt; <0.032 mg/m3) some- times observed in urban areas. In fact, available experimental data do not indicate that any adverse health effects are directly induced in humans at TLV® of 1,000 ppm (7,700 mg/m3) due to exposure to CFC-113. The health information pertaining to CFC-113 is discussed in detail. This document also discusses production, use, sources, emissions and ambient levels so that CFC-113 is placed in a real-world perspective. This Project Summary was developed by EPA's Environmental Criteria and Assessment Office. Research Triangle Park, NC, to announce key findings of the research project that is fully docu- mented in a separate report of the same title fsee Project Report ordering information at back). Introduction The principal intent of this document is to evaluate health effects associated with exposure to CFC-113. The nature of the known health effects primarily involves impairment of neurological and cognitive functions (humans) and cardiovascular system (animals) following acute exposure to levels greatly exceeding 1,000 ppm (7,700 mg/m3). The health information pertaining to CFC-113 is discussed in detail. In addition to evaluating the spectrum of health effects associated with CFC-113 release to the environment, ------- this document also discusses analytical methods, production, sources, emissions, and ambient levels to place CFC-113 in a real-world perspective. Chemical and Physical Properties Chlorofluorocarbons, in general, are characterized by high density, low boiling point, low viscosity, low surface tension, and high thermal andphotostability They do not react with most metals below 200°C nor do they generally react with acids or oxidizing agents. However, specific and unusual applications should be carefully reviewed and tested. Trichlofotrifluoroethane (CFC-113) is a nonflammable, colorless liquid, character- ized by a moderately high vapor pressure and a low boiling point (Table 1) and by high thermal and photostability. It is practically insoluble in water and is extremely resistant to hydrolysis. At equilibrium with a partial pressure of one atmosphere and at 86°F, less than 0.005 grams of CFC-113 per liter of water per year are hydrolyzed. Table 1. Physical Properties of CFC-113 Molecular weight Boiling point Vapor pressure Density Solubility 187.4 47.6°C (760 mm) 6.5 Ib/in* (25°C) 1.5 gm/cm3 0.017gm/100gmH2O (25°C. 760 mm) Air Quality Considerations Environmental Sources and Emissions Principal uses of CFC-113 fall into several mam categories (1) degreasmg, cleaning, and drying applications, (2) removal of solder flux, (3) critical cleaning of electronic, electrical and mechanical assemblies, (4) application as a cutting fluid, carrier and reaction medium, and (5) as a dry cleaning solvent. It is not used in aerosol formulations as a propellant or as a propellant component, but is used as a solvent or active ingredient in certain aerosol formulations. In cleaning and drying operations, two types of solvent losses occur: (1) escape in vapor form and (2) in liquid form when tanks are emptied for cleaning. Although there are not identified reports that CFC- 113 has been detected in drinking or surface waters, this potential exists since CFC 113 may be sealed in drums and buried Because CFC-113 has very limited solubility m water and is highly volatile, all releases of CFC-113 can be expected to eventually be conveyed to the atmosphere. The World Meteorological- Organization, citing figures supplied by E.I. duPont de Nemours and Company, reported a current global annual emissions rate of about 91,000 metric tons. Levels and Atmospheric Fate The World Meteorological Organization reported that ambient air levels are iathe range of 12 to 25 ppt in the northern hemisphere and 11 to 22 ppt in the southern hemisphere. Based on measure- ments made at sites in the United States, CFC-113 background tevelsare generally less than 20 ppt. Higher levels (—4,000 ppt) have occasionally been observed, ip, urban areas. • ' Because it is essentially inert in the troposphere, CFC-113 is transported slowly to the stratosphere. While CFC-113 has some potential to perturb stratospheric ozone, there is presently no evidence demonstrating that any indirect effects of CFC-113 on human health has or is likely to occur as a result of ozone perturbation. Because ozone effectively absorbs ultravio- let-B radiation, an actual decrease in stratospheric ozone concentration is expected to result in an increased amount of this biologically-damaging radiation (incident at the earth's surface). Human and Animal Studies Effects on Humans In regard to potential health effects associated with CFC-113, there is no evidence indicating that human health effects are likely to occur to ambient air mixing ratios (e.g., 18 ppt; 0.14 x 10~3 mg/m3) found or expected in the general environment or even at higher levels (<4,160 ppt; <0.032 mg/m3) sometimes observed m urban areas. In fact, available experimental data do not indicate that any adverse health effects are directly induced in humans at a TLAM' of 1,000 (7,700 mg/m3) due to exposure to CFC- 113. Human exposure to CFC-113 is predom- inantly by inhalation and most of it is rapidly cleared from the body by exhalation. Animal exposure studies indicate that CFC-113 partitions preferentially into lipid-rich tissues and is poorly metabolized. Loss of CFC-113 from all tissues is rapid during post-exposure periods, with virtually 100 percent clearance within 24 hours after cessation of acute exposure. At exposure levels greatly exceeding 1,000ppm (7,700 mg/m3), impairment of neurological and cognitive functions has been observed following acute exposure to CFC-113. However, because of the lack of detailed studies in this health area, a conclusive assessment of the human health risks posed by levels of CFC-113 in the range 1,500 to 2,000 ppm (7,700 to 15,400 mg/m3) cannot be made. Also, before definitive conclusions concerning the effects of chronic long-term exposure to CFC-113 can be drawn, the results of a recently completed two-year chronic inhalation study in rats must be evaluated. Animal Studies Various animal studies (non-human primates and dogs) have indicated that acute exposure to high concentrations of CFC-113 (as low as 2,000 ppm or 15,400 mg/m3 in a 6-hour exposure period) followed by a large injected dose of epinephrine resulted in cardiac arrhyth- mias. Concentrations as high as 20,000 ppm (154,000 mg/m3), however, did not sensitize a dog's heart to the dog's own circulating level of epinephrine even when it was elevated by exercise. Preliminary data from an industry- sponsored, two-year chronic inhalation study in rats indicate no hepatotoxic effects attributable to CFC-113 at doses as high as 20,000 ppm (154,000 mg/m3). Histopathology is in progress. There is presently inadequate published information to assess carcinogenic potential of CFC-113. Preliminary results of a recently-completed one-generation teratogenicity/reproductive toxicity study in pregnant rats suggest that at the exposure levels tested (5,000, 12,500, and 25,000 ppm), there was no evidence of teratogenic or embryotoxic effects attributable to CFC-113. Health Effects Conclusions There is no evidence indicating adverse health effects are likely to occur upor exposure to CFC-113 levels found 01 expected in the general information While there is inadequate published date to assess the teratogenic and carcinogenic potentials of CFC-113, preliminary result! of recently-completed, long-term inhala tion studies in rodents are consisten with no adverse effects attributable t< CFC-113 at levels up to 25,000 ppm Further testing would be needed befor definitive conclusions about the mutageni potential of CFC-113 could be drawn. ------- Richard C arch man is with the Virginia Commonwealth University, and the EPA author, Mark M. Greenberg (also the EPA Project Officer, see below), is with the Environmental Criteria and Assessment Office, Research Triangle Park, NC 27711. The complete report, entitled "Health Assessment Document for 1,1,2- Trichloro- 1.2,2-Trifluoroethane (Chlorofluorocarbon CFC-113)—Final Report," (Order No. PB 84-118 843; Cost: $11.50, subject to change) will be available only from: National Technical Information Service 5285 Port Royal Road Springfield, VA 22161 Telephone: 703-487-4650 The EPA Project Officer can be contacted at: Environmental Criteria and Assessment Office U.S. Environmental Protection Agency Research Triangle Park, NC 27711 i>US GOVERNMENT PRINTING OFFICE 1984-759-015/7257 ------- United States Environmental Protection Agency Center for Environmental Research Information Cincinnati OH 45268 BULK R/» U.S. POST PAID Cincinnati, Permit No. Official Business Penalty for Private Use $300 ------- |