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EC number: 203-782-3
CAS number: 110-60-1
For 1,4 -diaminobutane exposure based waiving is
jusitified because of low toxicological activity - only local irritation
effects, no unusual findings in the other organs and tissues examined to
suggest any systemic toxicity - and toxicokinetic data do not indicate
systemic absorption via relevant routes of exposure, and there is no
significant human exposure (since conditions at work are properly
controlled and the half-life of 1,4 -diaminobutane in air is extremely
Furthermore, in a reprotox study with the read across
substance Ethylenediamine dihydrochloride (EDA • 2HCl) no
reproductive toxicity was observed .Some effects were observed in
both sexes for the Fo and F1 parent rats. These effects were mainly
associated with the high dosage level and included reduction of body
weight gain and changes in liver (decrease) and kidney (increase)
weights in the adult rats. The only microscopic lesion observed was
hepatocellular pleomorphism in the high level F, adult males and
females; a greater prevalence and severity of this lesion was seen in
the female rats. The NOAEL of EDA.2HCl was reported to be 150
mg/kg/day (mating after 100 days of exposure).
The two-generation study with the other read across
substance, hexamethylenediamine (HMD), showed also a NOAEL of
150 mg/kg/day. Fertility was not adversely affected by the dietary
administration of HMD over two generations.
At birth pup body weights were not adversely affected
by treatment but during lactation reduced weights were apparent in both
sexes from the high dose group.
In addition, there were no treatment-related effects
on testes weights and no effects were noted by macroscopic or
microscopic examination of tissues evaluated
These results indicate that hexamethylenediamine
does not have significant systemic target organ toxicity.
No classification based on no indication of systemic
toxicity in repeated dose tests with 1,4 -diaminobutane, or in two
generation studies with the read across substances EDA and HMD.
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