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EC number: 203-468-6
CAS number: 107-15-3
In repeated dose studies, decreased body
weights and water and feed consumption have been observed, and are
probably related to the irritating nature of EDA and its high pH.
Hepatocellular pleomorphism has been observed and also increased ASAT
and ALAS values.
There are three oral repeat dose studies, the key study being a reasonable modern 90 day dietary study, with Ethylenediamine dihydrochloride. A NOAEL was determined at 22 mg/kg/day after adjustment to the dose level as Ethylenediamine base. There is also a 2 year cancer bioassay which had a NOAEL of 9 mg/kg/day but this NOAEL may have been quite higher as the next dose level was 45 mg/kg/day as Ethylenediamine base. The third oral study investigated specific effects on the eyes at a significantly higher dose with no NOAEL. There is a 6 -week inhalation study which established a NOAEC of 144 mg/m3 and a dermal study which had a NOAEL of at least 8.3 mg/kg bw/day (only dose tested).
Based on this the key value is the 22 mg/kg day NOAEL from the 90 day dietary study.
The classification for repeated dose toxicity for a 90-day study is based on serious adverse effects seen at dose levels of 100 mg/kg or less. In the 90 -day study the probably none reversible effect was seen at the highest dose level of 456 mg/kg/day with relatively minor effects at 114 mg/kg/day as ethylendiamine base. As the top dose at which the serious adverse effects were seen was well above the 100 mg/kg bw/day upper limit for classification of STOT (Specific Target Organ Toxicity) at Category 2, no classification for repeated dose toxicity is required under the current EU CLP and GHS criteria.
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