United States Environmental Protection Agency Office of Health and Environmental Assessment Washington, DC 20460 Research and Development EPA/600/S8-88/072 July 1988 SEPA Project Summary Health and Environmental Effects Profiles: Fiscal Year 1984 In 1984 a total of 96 Health and Environmental Effects Profiles were prepared by the Environmental Criteria and Assessment Office, Cincinnati, OH, for the Office of Solid Waste, Washington, D.C. These profiles are utilized to support listings of hazardous constituents of a wide range of waste streams under Section 3001 of the Resource Conservation and Recovery Act (RCRA). Both published literature and information obtained from Agency program office files were evaluated as they pertained to potential human health, aquatic life and environmental effects of hazardous waste constituents. This Project Summary was developed by EPA's Environmental Criteria and Assessment Office, Cincinnati, OH, to announce key findings of the research project that is fully documented in 96 separate reports (see Project Report ordering information at back). The Environmental Criteria and Assessment Office, Cincinnati, OH of the Office of Health and Environmental Assessment, Office of Research and Development prepared 96 Health and Environmental Effects Profiles (HEEPs) for the Office of Solid Waste in fiscal year 1984. These profiles provide a comprehensive review of all available information on the toxicological effects of specific chemicals or compounds, or chemical groups. Computerized literature searches were performed on a variety of scientific data bases, all pertinent Agen- cy files examined and hand searches of more recent literature performed. All information was compiled and evaluated pertaining to potential human health, aquatic life and environmental effects of hazardous waste constituents. The introductory material for each HEEP provides information on the molecular structure, CAS and NIOSH/ RTECS numbers, physical and chemical properties, and production and use data for each chemical. Environmental fate and transport processes in air, water and soil are also examined and related to potential and actual exposure of human and other biological systems to each toxic substance. The pharmacokinetic profile (absorption, distribution, metab- olism, and excretion data) of each chemical is also discussed. Subsequent sections of each HEEP discuss the health and environmental effects of exposure to the chemical(s). Experimental end points critically examined in each HEEP include carcinogenicity, mutagenicity, terato- genicity and other reproductive effects, and chronic and subchronic toxicity. Other effects relevant to risk estimation may also be noted. Acute and chronic effects in aquatic environments (e.,g., effects on plankton, macroinvertebrates and fish) may be discussed if data are avaiable. Acute, subchronic (i.e., exposure for an interval that does not constitute a significant portion of the lifespan) and chronic exposure data for any route of exposure are identified. In general, data that yield a more developed dose- response curve are more likely to be included in the HEEP literature summary. Although human epidemiological studies may also be described in the HEEP, most of the studies described utilize animal models. The final chapter of each HEEP presents a health risk assessment. Existing standards for aquatic environments and for human exposure are cited. Quantitative estimates are presented, provided sufficient data were available. For systemic toxicants (that is, ------- systemic refers to an effect other than carcinogenicity or mutagenicity induced by a toxic chemical), Acceptable Daily Intakes (ADIs) for chronic exposure are determined. An ADI is defined as the amount of a chemical to which humans can be exposed on a daily basis over an extended period of time (usually a lifetime) without suffering a deleterious effect. In the case of suspected carcinogens, ADIs are not estimated in this document series. Instead, a carcinogenic potency factor, or q-i", is provided. These potency estimates are derived for both oral and inhalation exposures where possible. In addition, unit risk estimates for air and drinking water are presented based on inhalation and oral data, respectively. Calculation of the ADI is based on a No-Observed-Adverse-Effect Level (NOAEL) or a No-Observed-Effect Level (NOEL) for chronic exposure. The NOAEL or NOEL is determined from an appropriate human or animal study. The chosen NOAEL (or NOEL) is divided by an uncertainty factors), which reduces the NOAEL by a factor of ten for each of several confounding factors. These factors include the protection of especially sensitive individuals in the population, extrapolation of animal data to human exposure, extrapolation of subchronic data to chronic exposure, and extrapolation of a Lowest-Observed- Adverse-Effect Level (LOAEL) to a NOAEL, When existing studies are not sufficient for risk assessment, the best of the available studies are summarized. deficiencies in study design are noted, and areas requiring additional research are identified. In some cases Confidential Business Information (CBl) files have been summarized as they pertain to risk assessment. Chemicals under study may also be evaluated for carcinogenic potential basod upon carcinogenesis studies of males and females of one or more species of animals. Chemicals are considered carcinogenic in animals if data from animal studies demonstrate a clear dose-response relationship be- tween exposure and tumorigenesis, or if highly suggestive evidence of tumor- igenesis in animals is supported by positive results in human exposure studios and/or mutagenesis assays. The cancer unit risk, q-i", is usually derived from a linearized multistage model with 95% upper confidence limits providing a low-dose estimate of cancer risk. It represents an increment of risk per milligram of chemical per kilogram of body weight per day. The cancer risk is characterized as being an upper limit estimate, that is, the true risk to humans, while not identifiable, is not likely to exceed the upper limit estimate and in fact may be lower. The carcinogenicity of a chemical or compound may also be classified according to the scheme developed by EPA's Carcinogen Assessment Group based on the weight of evidence of carcinogenicity in human and animal data. This classification consists of five groups: Group A: Human Carcinogen This group is used only when there is sufficient evidence from epidemiologic studies to support a causal association between exposure to the agents and cancer. Group B: Probable Human Carcinogen This group includes agents for which the weight of evidence of human carcinogenicity based on epidemiologic studies is "limited" and also includes agents for which the weight of evidence of carcinogenicity based on animal studies is "sufficient". Group C: Possible Human Carcinogen This group is used for agents with limited evidence of carcinogenicity in animals in the absence of human data. Group D: Not Classifiable as to Human Carcinogenicity This group is generally used for agents with inadequate human and animal evidence of carcinogenicity or for which no data are available. Group E: Evidence of Non- Carcinogenicity for Humans This group is used for agents that show no evidence for carcinogenicity in at least two adequate animal tests in different species or in both adequate epidemiologic and animals studies. This designation should.not be interpreted,as a definitive conclusion that the agent will not be a carcinogen under any circumstances. Each HEEP document concludes with a list of primary and secondary references and a tabular summary of the study or studies used for risk assess- ment. The quantitative risk assessment conclusions are presented in Table 1 for carcinogens and Table 2 for noncarcin- ogens. In the 96 documents, 111 specific chemicals, compounds and isomers are evaluated. Of these 33 are human or animal carcinogens and 78 are either noncarcinogens, or are of unknown car- cinogenic potential. Acceptable Daily Intake values are determined for 51 of the 78. Table 1 Carcinogens" Chemical qi" (mg/kg bw/day)-' Acephate 6.6 x TO'3 Alachlor 7 x 70-' Bromacil 6.4 x TO"2 Bromoethene 1.1x10-' 1,3-Butadiene ID Captafol 8.6 x 10-3 Captan 1.Qx1Q-2 Chlorobenzilate 1.7 x 10-' Chlorothalonil 2.9 x 10~3 Diallate 7.8 x 10-' Dibenzofurans, tetra-, penta-, & hexachloro ID 1,2-Dibromoethane ID 1,2-Diethylhydrazine ID 1,1-Dimethylhydrazine 8.7 1,2-Dimethylhydrazine 1.4 x 10$ Dioxins, tetra-, penta-, ID & hexachl.or,o-£Hbenzo-p- . .. .-~~±--.~— Ethylene thiourea 1.8 x 10-' Folpet 5.0 x 10-3 Hydrazine ID Hydrazine sulfate 3.0 Unuron 9.8 x TO'3 Methylene, 4-4'-(bis) 2.5 x 10-' benzeneamine Methylhydrazine 1.1 Oxirane 7-3 2-Phenylphenol 1.9 x TO-3 Profturalin 2.8 x W2 Propazine 7.8 x TO'2 Sodium diethyl 2.5x10-' dithiocarbamate Stirofos 2.4 x 10-2 Toluidines o-isomer 2.4 x 10-' m-isomer ID p-isomer 1.9 x 10-' Trifluraline 2.9 x 10~2 "As new data are generated, these values are subject to change ID = Insufficient data Table 2 Noncarcinogens" Chemical = ADI (mg/kg bw/day) Allidochlor ID Ametryn 1 x 10'2 Atrazine ID Benefin 2.5 x 10'' 1,1-Biphenyl 5 x 10'2 Brominated diphenyl ethers Pentabromo- 4.4 x TO"4 Octabromo- 6.2 x TO"4 Decabromo- T x TO"2 Bromobenzenes Class ND 1,4-Dibromo- 1 x TO"2 1,2,4-Tribromo- 5 x TO"3 Hexabromo- 2 x TO"3 Bromoxynil 6 x TO"2 Bromoxynil octanoate 3 x 10'' Busan 77 ID ~~ ~~ (Continued) ------- Table 2 (Continued) Chemical Susan 90 Butylate Butyrolactone, gamma- Carbaryl Carbofurans 2-Chloro-1,3- butadiene Chloropropenes 3-Chloropropene 1 ,2,3-Trichloro- propene Other isomers Chlorpyrifos Chlorpyrifos, methyl Chrysene Cyanazine Cycloate Dalapon 2,4-DB DCPA Diazinon Dichlorobutenes Dichloroprop Dimtehoate Dimethyl terphthalate Dinitrophenols 2,4-isomer Other isomers Dinoseb EPTC Ethoprop Fluridone Isopropalin Mancozeb Maneb MCPA MCPB MCPP Mephosfolan Merphos Merphos oxide Methylcyclohexane Methyl ethyl benzenes Molinate Monochlorobutanes N, N-Dimethylurea N-Propyl alcohol Pebutate: -•"••.. Pendimethalln Phosphorothioic acid, trimethyl esters Propachlor 2-Propenoic acid Ronnel Selected toluenediamines 2,5-isomer 2,6-isomer Other isomers Simazine TCMTB Temephos ADI (mg/kg bw/day) ID 1 X 10"< ID 9.6 x 10'2 ID 1.9 x W"3 1.6 x 10'3 4.6 x TO'3 ID 1 x 10'2 1 X 70"2 ID 6 x 70"3 ID 8.5 x W'2 ' 8 x70"3 4.8 x W'2 9 x 10~4 ID 2.5 x 10~1 2.0 x JO"2 8.8 ID ID 1 x W'3 5 x TO"2 ID 9 x 10~2 5.6 x 10~2 2.9 x 10~2 5 x 10'3 1 x 10'3 1 x 10~3 3.4 x W'3 9x 70-5 7.8 x 70"3 2.5 x 70"3 ID ID 6.3 x 10~4 ID ID ID 5 x 10'2 5 x 10'3 ID 1.3 x 10'2 ID 5 x W'2 5.6 x 10"1 1.6x 10"! ID ID 2.5 x 10'2 5.4 x 70~3 (Continued) Table 2. (Continued) Chemical Terbufos Terephthalic acid Triallate Trichloropropanes Trinitrophenols Vernolate 4-Vinyl-l -cyclohexene Zineb ADI (mg.'kg bw/day) 1 x 104 ID 1,5 x W'2 ID ID 5 x W2 ID 5 x 10~2 "As new data are generated, these values are subject to change ID = Insufficient data ND = Not determined This Project Summary was prepared by staff of the Environmental' Criteria and Assessment Office, USEPA, Cincinnati, OH 45268. This Project Summary covers 96 separate reports, entitled "Health & Environmental Effects Profile for-," Acephate (Order No. PB 88-162 466/AS; Cost: 12.95) Alachlor (Order No. PB 88-137 864/AS; Cost: 12.95) Allidochlor (Order No. PB 88-161 971/AS; Cost: 12.95) Ametryn (Order No. PB 88-162 359/AS; Cost: 12.95) Atrazine (Order No. PB 88-161 948/AS; Cost: 12.95) Benefin (Order No. PB 88-161 625/AS; Cost: 12.95) Benzenamine 4,4'-Methylenebis (Order No. PB 88-129 598/AS; Cost: 12.95) 1,l'-Biphenyl (Order No. PB 88- 137 831/AS; Cost: 12.95) Bromacil (Order No. PB 88-120 506/AS; Cost: 12.95) Brominated Diphenyl Ethers (Order No. PB 88-131 529/AS; Cost: 12.95) Bromobenzenes (Order No. PB 88- 137 757/AS; Cost: 14.95) Bromoethene (Vinyl Bromide) (Order No. PB 88-130 125/AS; Cost: 12.95) Bromoxynil (Order No. PB 88-129 622/AS; Cost: 12.95) Bromoxynil Octanoate (Order No. PB 88-137 906/AS; Cost: 12.95) Busan 77 (Order No. PB 88-129 606/AS; Cost: 12.95) (Continued) NTIS Information (Continued) Busan 90 (Order No. PB 88-161 922/AS; Cost: 12.95) 1,3-Butadiene (Order No. PB 88- 102 7441 AS; Cost: 13.95) Butylate (Order No. PB 88-137 781/AS; Cost: 12.95) Captafol (Order No. PB 88-162 003/AS; Cost: 12.95) Captan (Order No. PB 88-161 930/AS; Cost: 14.95) Carbaryl (Order No. PB 88-131 131/AS; Cost: 19.95) Carbofuran (Order No. PB 88-130 117!AS; Cost: 14.95) Chlorobenzilate (Order No. PB 88- 129 6141 AS; Cost: 12.95) 2-Chloro-1,3-Butadiene (Order No. PB 88-107 511/AS; Cost' 13.95) Chloropropenes (Order No. PB 88- 107 8001 AS; Cost: 11.95) Chlorpyrifos and Chlorpyrifos- Methyl (Order No. PB 88-161 955!AS; Cost: 14.95) Chlorthalonil (Order No. PB 88-162 300/AS; Cost: 12.95) Chrysene (Order No. PB 88-131 123/AS; Cost: 14.95) Cyanazine (Order No. PB 88-162 409/AS; Cost: 12.95) Cycloate (Order No. PB 88-130 109/AS; Cost: 12.95) Dalapon (Order No. PB 88-162 4581AS; Cost: 14.95) 2,4-DB (Order No. PB 88-129 564,AS; Cost: 12.95) DCPA (Order No. PB 88-161 906,AS; Cost: 12.95) Diallate (Order No. PB 88-111 844.AS; Cost: 12.95) Diazinon (Order No. PB 88-162 425/AS; Cost: 14.95) 1,2-Dibromoethane (Order No. PB 88-131 107/AS; Cost: 14.95) Dichlorobutenes (Order No. PB 88- 104 351/AS; Cost: 11.95) Dichloroprop (Order No. PB 88-161 633/AS; Cost: 12.95) 1,2-Diethylhydrazine (Order No. PB 88-137 765/AS; Cost: 12.95) Dimethoate (Order No. PB 88-161 997/AS; Cost: 14.95) 1,1-Dimethylhydrazine (Order No. PB 88-130 083/AS; Cost: 14.95) 1,2-Dimethylhydrazine (Order No. PB 88-137 773/AS; Cost: 14.95) (Continued) ------- TfS fnft dJL Dimethyl Terephthalate (Order No. PB 88-137 849/AS; Cost: 12.95) N.N-Dimethylurea (Order No. PB 88-131 099/AS; Cost: 12.95) Dinitrophenols (Order No. PB 88-137 872/AS; Cost: 12.95) Dinoseb (Order No. PB 88-162 185/AS; Cost: 14.95) EPTC (Order No. PB 88-112 289 IAS; Cost: 12.95) Elhoprop (Order No. PB 88-137 856IAS; Cost: (12.95) Elhylene Thiourea (Order No. PB 88-120 621/AS; Cost: 14.95) Folpel (Order No. PB 88-162 4331 AS; Cost: 14.95) Ftuoridorte (Order No. PB 88-161 9141 AS; Cost: 12.95) Gamma-Butyrolacetone (Order No. PB 88-130 0911 AS; Cost: 12.95) HydrazirtQ and Hydrazine So/fate (Order No. PB 88-161 9631AS; Cost: 12.95) Isopropalin (Order No. PB 88-162 417/AS; Cost: 12.95) Linuron (Order No. PB 88-120 654/AS; Cost: 12.95) Mancozeb (Order No. PB 88-120 522/AS; Cost: 12.95) Afa/i06 (Order No. PB 88-118 930IAS; Cost: 14.95) MCPA and MCPB (Order No. PB 88-162 391/AS; Cost: 14.95) MCPP (Order No. PB 88-162 383IAS; Cost: 12.95) Mephosfolan (Order No. PB 88-162 326/AS; Cost: 12.95) Merphos (Order No. PB 88-129 5721 AS; Cost: 12.95) Merphos Oxide (Order No. PB 88-129 580/AS; Cost: 12.95) Methytoyctohexane (Order No. PB 88-137 898/AS; Cost: 12.95) Methyl Ethyl Benzenes (Order No. PB 88-131 115/AS; Cost: 12.95) Methylhydrazine (Order No. PB 88-131 0651'AS; Cost: 12.95) Molinate (Order No. PB 88-137 799/AS; Cost: 12.95) Monochlorobutanes (Order No. PB 88-105 929/AS; Cost: 11.95) The above reports will be available only from: (cost: subfect to change) National Technical Information Service 5285 Port Royal Road Spring field, VA 22161 - Telephone: 703-487-4650 Oxirane (Order No. PB 88-162 318/AS; Cost: 14.95) Pebulate (Order No. PB 88-137 8071 AS; Cost: 12.95) Pendimethalin (Order No. PB 88-129 630/AS; Cost: 12.95) 2-Phenylphenol (Order No. PB 88-161 989/AS; Cost: 14.95) Phosphorothioic Acid, Trimethyl Esters (Order No. PB 88- 137 880/AS; Cost: 12.95) Profluralin (Order No. PB 88-162 3341 AS; Cost: 12.95) Propachlor (Order No. PB 88-162 177/AS; Cost: 12.95) Propazine (Order No. PB 88-161 617/AS; Cost: 12.95) 2-Propenoic Acid (Order No. PB 88-137 823/AS; Cost: 12.95) n-Propyl Alcohol (Order No. PB 88-103 7831 AS; Cost: 11.95) Ronnel (Order No. PB 88-142 8151 AS; Cost: 12.95) Selected Toluenediamines (Order No. PB 88-131 073/AS; Cost: 12.95) Simazine (Order No. PB 88-162 3671 AS; Cost: 14.95) Sodium Diethyldithiocarbamate (Order-No:-PB 88-120' 720/AS; Cost: 12.95) Stirofos (Order No. PB 88-162 441/AS; Cost: 12.95) TCMTB (Order No. PB 88-161 641/AS; Cost: 12.95) Temephos (Order No. PB 88-162 342/AS; Cost: 12.95) Terbufos (Order No. PB 88-142 807/AS; Cost: 12.95) Terephthalic Acid (Order No. PB 88-137 7321 AS; Cost: 12.95) Tetra-, Penta- and Hexachlorodibenzo-p-Dioxins (Order No. PB 88-103 833/AS; Cost: (24.95) Tetra-, Penta-, and Hexachlorodibenzofurans (Order No. PB 88-107 008/AS; Cost: 13.95) Toluidines (Order No. PB 88-130 0751 AS; Cost: 14.95) Triallate (Order No. PB 88-119 417/AS; Cost: 12.95) Trichloropropanes (Order No. PB 88-137 740/AS; Cost: 12.95) Trifluralin (Order No. PB 88-162 375/AS; Cost: 14.95) Trinitrophenols (Order No. PB 88-131 0811 AS; Cost: 12.95) Vernolate (Order No. PB 88-137 815/AS; Cost: 12.95) 4-Vinyl-1-Cyclohexene (Order No. PB 88-105 9371 AS; Cost: 11.95) Zineb (Order No. PB 88-120 738/AS; Cost: 12.95) For information, C.T. DeRosa can be contacted at: Environmental Criteria and Assessment Office U.S. Environmental Protection Agency _ ""' Cincinnati, OH 45268 "" United States Environmental Protection Agency Center for Environmental Research Information Cincinnati OH 45268 Official Business Penalty for Private Use $300 EPA/60Q'S8-88/072 ------- |