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ethylene diamine |
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Health assessment information on a chemical substance is included in IRIS only after a comprehensive review of chronic toxicity data by U.S. EPA health scientists from several Program Offices and the Office of Research and Development. The summaries presented in Sections I and II represent a consensus reached in the review process. Background information and explanations of the methods used to derive the values given in IRIS are provided in the Background Documents. STATUS OF DATA FOR Ethylene diamine File First On-Line 05/01/1991
I. Chronic Health Hazard Assessments for Noncarcinogenic EffectsI.A. Reference Dose for Chronic Oral Exposure (RfD)Substance Name -- Ethylene diamine I.B. Reference Concentration for Chronic Inhalation Exposure (RfC)Substance Name -- Ethylene diamine The health effects data for ethylene diamine were reviewed by the U.S. EPA RfD/RfC Work Group and determined to be inadequate for the derivation of an inhalation RfC. The verification status of this chemical is currently not verifiable. For additional information on the health effects of this chemical, interested parties are referred to the EPA documentation listed below. U.S. EPA. 1988. Health and Environmental Effects Document for Ethylene diamine. Prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Solid Waste and Emergency Response, Washington, DC. EPA/600/8-89/004. Agency Work Group Review -- 12/18/1990 EPA Contacts: Please contact the IRIS Hotline for all questions concerning this assessment or IRIS, in general, at (301)345-2870 (phone), (301)345-2876 (FAX) or hotline.iris@epa.gov (internet address). II. Carcinogenicity Assessment for Lifetime ExposureSubstance Name -- Ethylene diamine Section II provides information on three aspects of the carcinogenic assessment for the substance in question; the weight-of-evidence judgment of the likelihood that the substance is a human carcinogen, and quantitative estimates of risk from oral exposure and from inhalation exposure. The quantitative risk estimates are presented in three ways. The slope factor is the result of application of a low-dose extrapolation procedure and is presented as the risk per (mg/kg)/day. The unit risk is the quantitative estimate in terms of either risk per ug/L drinking water or risk per ug/cu.m air breathed. The third form in which risk is presented is a drinking water or air concentration providing cancer risks of 1 in 10,000, 1 in 100,000 or 1 in 1,000,000. The rationale and methods used to develop the carcinogenicity information in IRIS are described in The Risk Assessment Guidelines of 1986 (EPA/600/8-87/045) and in the IRIS Background Document. IRIS summaries developed since the publication of EPA's more recent Proposed Guidelines for Carcinogen Risk Assessment also utilize those Guidelines where indicated (Federal Register 61(79):17960-18011, April 23, 1996). Users are referred to Section I of this IRIS file for information on long-term toxic effects other than carcinogenicity. II.A. Evidence for Human CarcinogenicityII.A.1. Weight-of-Evidence CharacterizationClassification -- D; not classifiable as to human carcinogenicity Basis -- Based on no human data and inadequate animal data. II.A.2. Human Carcinogenicity DataNone. II.A.3. Animal Carcinogenicity DataInadequate. As discussed in Yang et al. (1984a,b), Union Carbide researchers conducted a 2-year carcinogenicity study of oral ethylene diamine dihydrochloride in F344 rats in which 25 male and 26 female rats (FO) were fed a diet containing either 0.05, 0.15 or 0.5 g/kg/day (50, 150 or 500 mg/kg/day, respectively). These doses were determined from a previous study (Yang and Tallant, 1982). A control group of 50 males and 52 females was fed a basal diet. The FO parents were treated for 100 days then mated. After mating, the males were used in another assay. The offspring of the treated animals, 15 males and 26 females (F1), were fed the same three doses in the diet. Necropsies were performed on F1 weanlings (5 rats/sex/dose and 10 control rats/sex) and F1 adults (10 rats/sex/dose and 20 control rats/sex). Yang et al. (1984b) indicated that the most significant microscopic lesion observed was hepatocellular pleomorphism, which is characterized by enlarged hepatocytes and hepatocyte nuclei, variations in nuclear shape, and increased numbers of multinucleate hepatocytes. DePass et al. (1984) conducted a lifetime dermal bioassay of 99.1% pure ethylene diamine in male C3H/HeJ mice. Twenty-five uL of a 1% ethylene diamine solution in deionized water was applied to the skin of two groups of 50 mice 3 times/week until death. (The mean survival time for the three groups was at least 598 days.) (Two different chemical manufacturers supplied ethylene diamine for the groups.) A control group of 50 mice received similar applications of the vehicle and a positive control group of 40 mice received repeated applications of 0.1% 3-methylcholanthrene in acetone. The mean survival times of the two treated groups, the vehicle control group, and the positive control group were 639, 598, 626 and 204 days, respectively. Animals in all groups were individually housed, except for the positive control group, which was housed 5/cage. Another group of 40 mice housed 5/cage was used as a housing control for the positive control group. The mean survival time of the housing controls was 488 days. The investigators conducted complete gross necropsies on all the mice, and subjected the dorsal skin and all gross lesions to histologic examination. No evidence of epidermal tumors was found in either group of treated mice, the individually-housed vehicle controls, or the group-housed vehicle controls. In contrast, 98% of positive control mice had skin tumors, including 92% with squamous cell carcinomas. II.A.4. Supporting Data for CarcinogenicityEthylene diamine produced a weakly mutagenic response in four Salmonella typhimurium strains, both in the presence and the absence of an S9 homogenate fraction (Haworth et al., 1983; Hedenstedt, 1978; Hulla et al., 1981). Ethylene diamine was negative in a sister chromatid exchange assay and HGPRT gene mutation assay in Chinese hamster ovary cells, both in the presence and the absence of metabolic activation. It was also negative in an unscheduled DNA synthesis assay in Sprague-Dawley rat hepatocytes (Slesinski et al., 1983). Zimmering et al. (1985) found that both dietary and injected ethylene diamine was negative in sex-linked recessive lethal assays in Drosophila. Ethylene diamine is a water-soluble molecule with little affinity for body fat (Yang et al., 1984a). This study is unusual in that it was designed to provide both cancer and pharmacokinetic data. The major urinary and fecal metabolite after oral administration in rats is N-acetylethylenediamine, which may subsequently undergo further metabolism to ethylene diamine, aminoacetaldehyde, ethanolamine, and, eventually, carbon dioxide (Yang and Tallant, 1982). II.B. Quantitative Estimate of Carcinogenic Risk from Oral
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Date
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Section
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Description
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| 05/01/1991 | I.B. | Inhalation RfC message on-line |
| 05/01/1991 | VI. | Bibliography on-line |
| 09/01/1991 | II. | Carcinogenicity assessment now under review |
| 01/01/1992 | IV. | Regulatory Action section on-line |
| 11/01/1992 | II. | Carcinogenicity assessment on-line |
| 11/01/1992 | VI.C. | Carcinogenicity references on-line |
| 12/01/1992 | VI.C. | Slesinski reference clarified |
| 07/01/1993 | II.D.1. | Other EPA Documentation heading removed |
| 12/01/1996 | II.D.3. | Secondary contact removed |
| 04/01/1997 | III., IV., V. | Drinking Water Health Advisories, EPA Regulatory Actions, and Supplementary Data were removed from IRIS on or before April 1997. IRIS users were directed to the appropriate EPA Program Offices for this information. |
Substance Name -- Ethylene diamine
CASRN -- 107-15-3
Last Revised -- 05/01/1991
107-15-3
1,2-Ethanediamine
Aethaldiamin [German]
Aethylenediamin [German]
Algicode 106L
Amerstat 274
BETA-AMINOETHYLAMINE
Caswell No. 437
Dimethylenediamine
EPA Pesticide Chemical Code 004205
Ethyleendiamine [Dutch]
Ethylendiamine
ETHYLENE-DIAMINE [French]
Ethylenediamine
Etilendiamina [Spanish]
HSDB 535
NCI-C60402
UN 1604
1,2-DIAMINO-ETHAAN [Dutch]
1,2-DIAMINO-ETHANO [Italian]
1,2-DIAMINOAETHAN [German]
1,2-diaminoethane
1,2-ETHANEDIAMINE
1,2-ETHYLENEDIAMINE
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