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Karl Loren Background

Contents

I.A. REFERENCE DOSE FOR CHRONIC ORAL EXPOSURE (RfD)

I.B. REFERENCE CONCENTRATION FOR CHRONIC
 

INHALATION EXPOSURE (RfC)

II. CARCINOGENICITY ASSESSMENT FOR LIFETIME EXPOSURE

VI. BIBLIOGRAPHY

VII. REVISION HISTORY

VIII. SYNONYMS

0528
Ethylene diamine; CASRN 107-15-3
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 On-Line 05/01/1991
Category (section)                           Status      Last Revised
-----------------------------------------    --------    ------------
Oral RfD Assessment (I.A.)                   no data
Inhalation RfC Assessment (I.B.)             message       05/01/1991
Carcinogenicity Assessment (II.)             on-line       12/01/1996

_I.  CHRONIC HEALTH HAZARD ASSESSMENTS FOR NONCARCINOGENIC EFFECTS


 
  __I.A.  REFERENCE DOSE FOR CHRONIC ORAL EXPOSURE (RfD)
 
Substance Name -- Ethylene diamine
CASRN -- 107-15-3
Not available at this time.

__I.B.  REFERENCE CONCENTRATION FOR CHRONIC INHALATION EXPOSURE (RfC)
 
Substance Name -- Ethylene diamine
CASRN -- 107-15-3
    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@epamail.epa.gov (internet address).

_II.  CARCINOGENICITY ASSESSMENT FOR LIFETIME EXPOSURE
 
Substance Name -- Ethylene diamine
CASRN -- 107-15-3
Last Revised -- 12/01/1996
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. CARCINOGENICITY ASSESSMENT FOR LIFETIME EXPOSURE

Substance Name -- Ethylene diamine
CASRN -- 107-15-3
Preparation Date -- 05/10/1991

__II.A.  EVIDENCE FOR CLASSIFICATION AS TO HUMAN CARCINOGENICITY


___II.A.1.  WEIGHT-OF-EVIDENCE CLASSIFICATION

Classification -- D; not classifiable as to human carcinogenicity
Basis -- Based on no human data and inadequate animal data.

___II.A.2.  HUMAN CARCINOGENICITY DATA

    None.

___II.A.3.  ANIMAL CARCINOGENICITY DATA

    Inadequate.  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 CARCINOGENICITY

    Ethylene 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 ESTIMATES OF CARCINOGENIC RISK FROM ORAL EXPOSURE

    None.

___II.C. QUANTITATIVE ESTIMATE OF CARCINOGENIC RISK FROM INHALATION EXPOSURE

    None.

__II.D.  EPA DOCUMENTATION, REVIEW, AND CONTACTS (CARCINOGENICITY ASSESSMENT)


___II.D.1.  EPA DOCUMENTATION

Source Document -- U.S. EPA, 1988
The 1988 Health and Environmental Effects Document for Ethylene diamine has
received full review from the Office of Health and Environmental Assessment
and from the Office of Pesticides and Toxic Substances.

___II.D.2.  REVIEW (CARCINOGENICITY ASSESSMENT)

Agency Work Group Review -- 07/25/1991
Verification Date -- 07/25/1991

___II.D.3.  U.S. EPA CONTACTS (CARCINOGENICITY ASSESSMENT)

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@epamail.epa.gov (internet address).

_VI.  BIBLIOGRAPHY
 
Substance Name -- Ethylene diamine
CASRN -- 107-15-3
Last Revised -- 12/01/1992

__VI.A.  ORAL RfD REFERENCES

None

__VI.B.  INHALATION RfC REFERENCES

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.

__VI.C.  CARCINOGENICITY ASSESSMENT REFERENCES

DePass, L.R., E.H. Fowler and R.S.H. Yang.  1984.  Dermal oncogenicity studies
on ethylenediamine in male C3H mice.  Fund. Appl. Toxicol.  4(4): 641-645.
Haworth, S., T. Lawlor, M. Mortelmans, W. Speck and E. Zeiger.  1983.
Salmonella mutagenicity test results for 250 chemicals.  Environ. Mutagen.
Suppl.  5(Suppl. 1): 10-11, 94-95.
Hedenstedt, A.  1978.  Mutagenicity screening of industrial chemicals: Seven
aliphatic amines and one amide tested in the Salmonella/microsomal assay.
Mutat. Res.  53: 198-199.
Hulla, J.E., S.J. Rogers and G.R. Warren.  1981.  Mutagenicity of a series of
polyamines.  Environ. Mutagen.  3: 332-333.
Slesinski, R.S., P.J. Guzzie, W.G. Hengler, P.G. Watanabe, M.D. Woodside and
R.S.H. Yang.  1983.  Assessment of genotoxic potential of ethylenediamine: In
vitro and in vivo studies.  Mutat. Res.  124(3-4): 299-314.
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.
Yang, R.S.H. and M.J. Tallant.  1982.  Metabolism and pharmacokinetics of
ethylenediamine in the rat following oral, endotracheal or intravenous
administration.  Fund. Appl. Toxicol.  2(5): 252-260.
Yang, R.S.H., M.J. Tallant and J.A. McKelvey.  1984a.  Age-dependent
pharmacokinetic changes of ethylenediamine in Fischer 344 rats parallel to a
2-year chronic toxicity study.  Fund. Appl. Toxicol.  4(4): 663-670.
Yang, R.S.H., R.H. Garman, E.V. Weaver and M.D. Woodside.  1984b.  Two-
generation reproduction study of ethylenediamine in Fischer 344 rats.  Fund.
Appl. Toxicol.  4(4): 539-546.
Zimmering, S., J.M. Mason, R. Valencia and R.C. Woodruff.  1985.  Chemical
mutagenesis testing in Drosophila.  2. Results of 20 coded compounds tested
for the National Toxicology Program.  Environ. Mutagen.  7: 87-100.

_VII.  REVISION HISTORY
 
Substance Name -- Ethylene diamine
CASRN -- 107-15-3
--------   --------   --------------------------------------------------------
Date       Section    Description
--------   --------   --------------------------------------------------------
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.,  Drinking Water Health Advisories, EPA Regulatory Actions, and
             V.         Supplementary Data were removed from IRIS on or before April
                        1997. IRIS users were directed to the appropriate EPA Program
                        Offices for this information.

VIII. SYNONYMS
 
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
.

Last updated: 5 May 1998
URL: http://www.epa.gov/iris/subst/0528.htm

 

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