Ethylenediamine

Endpoint summary

Description of key information

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.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

22 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Quality of whole database:

Well reported good quality study Klimisch 2.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEC

327 mg/m³

Study duration:

subacute

Species:

rat

Quality of whole database:

Somewhat limited study of 6 week duration, full details are not available in the publication.

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

8.3 mg/kg bw/day

Study duration:

chronic

Species:

mouse

Quality of whole database:

Study limited by single dose level but did include positive control. Study was aimed at comparing two samples of ethylene diamine with different impurity profiles. The study demonstrated no adverse effects at highest none irritant dose.

Additional information

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.

Justification for classification or non-classification

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.