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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.
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