United States Environmental Protection Agency Environmental Criteria and Assessment Office Cincinnati OH 45268 Research and Development EPA/600/S8-82/001FApr. 1987 Project Summary Health Assessment Document for Carbon Tetrachloride Cynthia Sonich-Mullin The Office of Health and Environmen- tal Assessment (OHEA), in consultation with an Agency work group, has pre- pared this hearth assessment to serve as a "source document" for EPA use. Originally the hearth assessment was developed for use by the Office of Air Quality Planning and Standards; how- ever, at the request of the Agency Work Group on Solvents, the assessment scope was expanded to address multi- media aspects. In the development of this assess- ment document, the scientific literature has been inventoried, key studies have been evaluated, and summaries and conclusions have been prepared so that the chemical's toxicity and related char- acteristics are qualitatively identified. Observed effect levels and dose- response relationships are discussed evaluating the potential toxicity of CCI4. Unit risk estimates for cancer are calcu- lated to provide a media-specific meas- ure of toxicity. This information can then be placed in perspective with ob- served environmental levels. This Project Summary was devel- oped by EPA's Environmental Criteria and Assessment Office, Cincinnati, OH, to announce key findings of the re- search protect that is fully documented in a separate report of the same title (see Project Report ordering informa- tion at back). Summary Carbon tetrachloride (CCI4) is a rela- tively nonpolar compound that is slightly soluble in water, soluble in alco- hol and acetone, and miscible in ben- zene, chloroform and ether. Its density is 1.59 g/me at 4°C which is greater than the density of water. Thus, under favor- able conditions, large amounts spilled into water may settle and not volatilize. However, the high vapor pressure of CCU 015.2 mm Hg at 25°C) favors volatilization from water to air. Carbon tetrachloride is produced commercially from the chlorination of several chemicals such as methane, propane, ethane propylene and carbon disulfide. In 1980, 3.22 x 108 kg were produced in the United States. A much smaller amount of CCI4 is generated during the production of vinyl chloride and perchloroethylene. The major use of CCI4 is in the production of chloroflu- orocarbons. A reduction in the demand for CCI4 has resulted in a 3.5% decrease in production over the years 1970-1980. A continued 1.0% decline in production is projected each year through 1985. Carbon tetrachloride can be detected in the environment using media- specific analytical methods. Levels de- tected in the environment are generally <0.01 mg/ein water, <0.01 mg/m3 in air, and <0.01 mg/kg in food although higher levels have been detected in urban air and grain fumigated with CCI4. Food products made from this grain also contain residues of CCI4. Natural sources of CCI4 are unknown so that most, if not all CCI4 present in the envi- ronment can be accounted for by an- thropogenic activities. Carbon tetrachloride is extremely sta- ble in the lower atmosphere and tropo- sphere; however, once in the strato- sphere, photodissociation is rapid. Its presence in the stratosphere is of con- cern due to its possible contribution to ozone depletion and subsequent mod! fication of UV-B radiation flux. The ex- tent of this contribution cannot pres- ently be estimated for CCI4 due to numerous significant uncertainties in modeling and data. Increased UV-B ra- ------- diation studies in the laboratory have shown adverse effects to a variety of terrestrial plant species; for example, in terms of depressed photosynthetic ac- tivity, reduced growth rate, increased somatic mutation rates, and inhibition of seed germination. In laboratory stud- ies, some aquatic organisms have also been shown to be adversely affected. Direct extension of these laboratory findings to the natural environment should not be made because of adapt- ability potential to small changes in LIV- ES flux. Indirect ecosystem effects asso- ciated with increases in UV-B radiation flux have been identified to include changes in genetic material and possi- ble alterations in population composi- tion. However, it is not known if these laboratory findings apply to the natural environment due to observed adapta- tions. The implication of increased UV-B flux to human populations is that >90% of skin cancer (other than melanoma) in the United States is attributed to sun- light in the UV-B region. When present in water in dilute con- centrations, CCI4 is rapidly lost to the atmosphere by volatilization. However, large quantities of CC!4 spilled into water may settle and persist, due to its high specific gravity, low water solubil- ity and high chemical stability. In such cases its presence in ambient water or drinking water may present a threat to aquatic ecosystems or human health. Humans are potentially exposed to CCI4 through various media. For an adult male, the typical exposure is esti- mated at 13 jig/day from inhalation, 9 M-g/day from fluid intake and 4 ^g/day from food intake. Uptake from air ap- pears to be the major source of expo- sure followed by liquids and food. For this reason, the fate and transport of CCI4 has been most extensively studied in air. Information on CCI4 soil contami- nation is limited; consequently, its con- tribution to human exposure is uncer- tain. Ecological impacts have been moni- tored to a limited extent in freshwater and saltwater organisms. Only two freshwater fish and one invertebrate species have been acutely tested; a 96- hour LCgo has been determined as low as 27.3 mg/e in the bluegill, Lepomis macrochirus. Chronic toxicity data are not available. However, reported bio- concentration factors are <30 so that tissue residues are insignificant. The only data on saltwater species deals with toxicity following acute exposures. Effects have been identified at levels of 50.0 mg/e. It is noted that the toxic dose for both freshwater and saltwater spe- cies can be lower if more sensitive spe- cies were tested. In mammals, CCI4 is readily absorbed from the lungs and gastrointestinal tract. Absorption also occurs through the skin but at a much slower rate. Fol- lowing absorption, CCI4 is distributed to all major organs. Metabolism of the compound occurs primarily in the liver where it is reduced to a trichloromethyl radical and thought to be further metab- olized and/or released as a free radical. Excretion of CCI4 is primarily through the lungs but also occurs in the urine and feces. Quantitative estimates are available only for inhalation absorption efficiency; these range from 30-65%. Varying degrees of toxicity have been reported in humans and animals follow- ing acute, subchronic and chronic expo- sures via ingestion, inhalation or der- mal administration. Such effects can occur systemically as well as locally. For example, cirrhosis of the liver has re- sulted from inhalation and dermal ex- posures, whereas lung lesions have re- sulted from oral ingestion. Animals surviving acute doses have developed a range of effects such as damage to the liver, kidney, lung and central nervous system as well as dermal effects; bio- chemical alterations were also noted. Animals receiving subchronic and chronic doses have developed kidney and liver damage and, less frequently, damage to the central nervous system. It has been observed that exposure to a higher concentration over a shorter pe- riod of time produces a greater effect upon the liver than exposure to a lower concentration over a longer period of time, even though the product of time and concentration is equal in both cases. In an attempt to verify the purity of CCI4 used in the testing protocols of the studies summarized in this document, it was observed that CCI4 of impure or technical grade was not reported; only the use of pure CCI4 was reported. Adverse effects recorded for humans following CCI4 exposure are similar to those observed in animals. Damage to the liver, kidney, lungs and central ner- vous system has been documented in various case reports. Biochemical alter- ations have been identified in case re- ports and one epidemiological study. Exposure to CCI4 did not produce skeletal or functional abnormalities but did result in signs of fetotoxicity. Rats exposed in utero to CCI4 were noted to have fatty infiltration of the liver from days 1-4 after birth. Carbon tetrachlo- ride has been shown to be transferred to the neonate through mothers' milk. Other adverse reproductive effects in- clude changes in testicular histology eventually resulting in functional infer- tility. Tests of the mutagenicity of CCI4 have been consistently negative in the Salmonella assay. A positive mutagenic response was seen in an assay using Saccharomyces cerevisiae; however, there have been problems associated with this study. Carbon tetrachloride has been found to produce (1) carcinogenic or neo- plastic responses in the liver of six strains of mice (C3H, B6C3F1, A, Y, C and L); (2) carcinomas in the liver of three strains of rat (Osborne-Mendel, Japanese, Wistar) and hyperplastic nodules in a fourth rat strain (Buffalo) in less than lifetime studies; (3) a small but statistically significant (as compared to pooled controls) hepatocellular car- cinoma response in female Osborne- Mendel rats in lifetime experiments; and (4) hepatocellular carcinomas in Syrian golden hamsters. Case reports of human carcinomas developing years after a history of high CCI4 exposures are suggestive of but not evidence for an association be- tween human carcinogenic risk and ex- posure to CCI4. Studies on groups ex- posed to CCI4 indicate that further research is necessary. If the criteria of the International Agency for Research on Cancer (IARC) were used, this evidence would be clas- sified as sufficient in animals and inade- quate in humans for an overall rating of 28. Estimates of excess human cancer risk from lifetime exposure to CCI4 have been extrapolated from the cancer stud- ies on animals. The recommended upper limit estimates of unit risk are from 3.1 x 10~7 to 3.4 x 10~5 for expo- sure to 1 (xg/f in water and from 1.2 x 10~6 to 1.4 x 10"4for exposure to in air. In assessing toxicity, carcinogenic!^ or any other harmful effect, compound! that react synergistically or antagonist! cally with CCI4 must be considered Identified synergistic substances in elude ethanol, kepone, PCB and PBE Antagonistic effects have been demon strated with such compounds as chic ramphenicol and catechol. ------- Conclusions Carbon tetrachloride may contribute to the long term, partial destruction of stratospheric ozone. Several uncertain- ties in the modeling and data preclude quantitative estimation of ozone deple- tion due to CCI4. Carbon tetrachloride causes damage to the liver, lungs, kidneys and central nervous system in humans. These ef- fects are primarily the result of high oral or inhalation exposures. Less severe ef- fects such as biochemical alterations, nausea and headache result from lower exposures or are secondary to the major health hazards attributed to higher exposures. Similar responses have been demonstrated in animals. These animal studies provide useful dose/response data, are well-defined and can identify a causal relationship between the CCI4 insult and the toxic response. Furthermore, the toxicity from CCI4 is not only local but also sys- temic. Absorption of CCI4 varies with spe- cies. Based upon both human and ani- mal data, absorption coefficients of 40% when route of exposure is via inhalation and 100% when route of exposure is via ingestion are recommended. The potential exists for embryotoxic- ity, especially in males. Toxic effects due to CCI4 have been demonstrated in mammalian fetuses and neonates ex- posed directly or indirectly via the pla- centa or mothers' milk, respectively. Teratogenic effects have not been noted following CCI4 exposure; however, de- generative changes in the testes and subsequent infertility of the offspring have occurred. Definitive conclusions concerning mutagenicity tests cannot be reached. Carbon tetrachloride did exhibit a posi- tive mutagenic response in an assay using Saccharomyces cerevisiae; how- ever, due to problems associated with the study and the lack of corroborative studies, the evidence is not adequate to conclude whether or not CCI4 is geno- toxic. Interactions with other chemicals must be considered in assessing the po- tential health hazards of exposure to CCI4. Chemicals have been identified that potentiate the effects of CCI4 as well as those that inhibit the effects of CCI4. Carcinogenicity of CCI4 has been ob- served in three animal species. The pri- mary lesions are hepatic neoplasms. Cirrhosis, necrosis and cholangiofibro- sis have also been found and have been suggested as initial lesions prior to tu- morigenesis in liver. Human data on carcinogenicity are restricted to case re- ports and one preliminary epidemiolog- ies I study. The animal data provide evi- dence to indicate that CCI4 is a potential human carcinogen. The combined evi- dence of animal and human studies would fall into IARC classification of 2B if the IARC criteria were used. The IARC description of this level of evidence is that this compound is probably carcino- genic for humans. Mechanism of action is an important issue in the assessment of the potential carcinogenicity of CCI4 to humans at low doses. ------- This Project Summary was prepared by staff of EPA's Environmental Criteria and Assessment Office. Cincinnati. OH 45268. Cynthia Sonich-Multin is the EPA Project Officer (see below). The complete report, entitled "Health Assessment Document for Carbon Tetrachloride—Final Report." (Order No. PB85-124 196; Cost: $30.95, 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 Cincinnati, OH 45268 United States Environmental Protection Agent*. Center for Environmental Research Information Cincinnati OH 45268 . ,,— \.,OH\0, Official Business Penalty for Private Use $300 EPA/600/S8-82/001F 10032* ------- |