Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-468-6
CAS number: 107-15-3
Table 2 Summary of Experimental Parameters
Dose level g/kg/day
No of pregnant females
Median No of implants/ pregnant female
Median viable implants/ pregnant female
Litters with all Foetuses viable
Median pre implantation loss!
Median No of Foetal Deaths/ Pregnant Female
Early and /or late
**Median % of fetal deaths
0.25 mg/kg *TEM
b : 0.01 > P > 0.001 c : P < 0.001
!Each median was obtained from individual derived from the following calculations:
Pre-implantation loss + corpora lutea – implantations/corpora lutea x 100
*TEM – Triethyenemelamine ** Percentage fetal death=No of fetal deaths/pregnant female x 100
No of implants/pregnant female
Table 3 Fertility Index
(g/kg/day for F0Males for 23 weeksa
Fertility Index*During Week
Positive Control (TEM 0.25mg/kg)
Fertility index = No of pairs mated that produced pregnancies / Total pairs mated x 100
Table 4 Ratios of Total No of females with
early deaths to no of females pregnant
No of females with early foetal deaths to no pregnant females*During Week
Percentage of pregnant females with one or more early foetal death during weeks
a : 0.05 >P >0.01
c : P <0.001
Table 5 Ratios of Total No of females with
late deaths to no of females pregnant
No of females with late foetal deaths to no pregnant females*During Week
Percentage of pregnant females with one or more late foetal death during weeks
Table 6 Ratios of Total No of females with
late deaths to no of females pregnant
No of females with early and/or late foetal deaths to no pregnant females*During Week
Percentage of pregnant females with one or more early and/or late foetal death during weeks
In conjunction with a two-generation
reproduction study, the possible dominant lethal effects of
ethylenediamine (EDA) were evaluated in Fischer 344 rats.
Ethylenediamine dihydrochloride (EDA-2HCl) was incorporated in the diet
of male and female rats at dosage goals of 0.50, 0.15 or 0.05 g/kg/day
during two generations of reproduction. One parallel control group
without EDA.2HCl in the diet was observed concurrently. After successful
completion of the F0–F1amating, the F0 male
rats which had received diets containing EDA.2HCl at 0.5, 0.15, 0.05 or
0 g/kg/day for 23 weeks were transferred to the dominant lethal study.
These male rats were removed from their dosage regimens and fed control
diet 24 hours prior to mating with naive females. Concurrently, a group
of naive male rats was given a single intraperitoneal dose of 0.25 mg/kg
triethylenemelamine (TEM) to serve as a positive control. A mating
regimen was followed sequentially for three consecutive weeks.
Approximately 13 days after conception, the female rats were sacrificed
and the uteri examined. The criteria examined included fertility,
corpora lutea count, number of implantations/female, late fetal
deaths/female and early foetal deaths/female.
No dose-related responses were found in any
of the criteria examined. However, marked mutagenic responses were noted
in the positive control animals (TEM treated) indicating that the rats
used in this study were susceptible to a known mutagen.
There is no evidence in this study
implicating EDA as a mutagen.
There were no genotoxic effects observed in
a Dominant Lethal Assay.
Weakly positive results in an Ames test with
Salmonella typhimurium strains TA 100, TA 1535 were reported by Haworth
(1983). Ambiguous results have been presented in additional test with
Salmonella typhimurium (Guzzie, 1987).
However Ames tests with Salmonella
typhimurium strains TA 98, 100, 1535 and 1537 reported by Willems (1979)
were negative. The cause of the weakly positive response has been
hypothesized to be due to an impurity. (Hedenstedt, 1978, as cited in
the SIDS Risk Assessment dossier for Ethylenediamine, 2001).
Genotoxic potential of EDA was tested by
Slesinski (1983) in different in vivo and in vitro tests. The in vitro
tests included a gene mutation assay on Chinese Hamster Ovary cells, a
sister chromatid exchange assay on Chinese Hamster Ovary cells and an
Unscheduled DNA synthesis on primary rat hepatocytes. All the tests gave
Negative results were also obtained in "in
vivo" tests, a Dominant lethal assay on Fischer 344 rats (Slesinski
1983c) and two Drosophila SLRL tests by oral and injection (Zimmering
Negative results were also obtained in an
"In vitro Mammalian Chromosome Aberration Test" according to OECD
Guideline 473 (Morris 2015)
In a chromosomal aberration test in human
lymphocytes, there was no statistically significant increase in the
frequency of cells with chromosome aberrations, in either the absence or
presence of a liver enzyme metabolizing system. The test item was
therefore considered to be non-clastogenic to human lymphocytes in vitro.
There were some weak positive results seen
in TA100 and to a lesser extent TA1535 in the Ames test, however in a
tests with a higher purity sample no such effects were seen. A
comprehensive selection of other in-vitro genotoxicity tests showed no
evidence in-vitro of mutagenicity in mammalian cells and no evidence of
clastogenicity in human lymphocytes. This was
confirmed by a lack of any genotoxicity in-vivo in a dominant lethal
study in rats and in drosophila both by administration by feeding and
injection. The weight of evidence is clearly that
ethylene diamine is not genotoxic (mutagenic or clastogenic) .
The weight of evidence from in-vitro and
in-vivo genotoxicity testing is that Ethylenediamine is not genotoxic. Ames
results were inconsistent, with some weak positive results reported in
TA100 and TA1535 but negative results with a high purity sample, all
other in-vitro and in-vivo tests were consistently negative showing no
evidence of mutagenicity in mammalian cells and no clastogenicity in
human lymphocytes. In-vivo data from a dominant lethal
study in rats and SLRL tests in Drosophila were consistently negative.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again