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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1952
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1952

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
14 day mortality of male rats exposed to metered concentrations of EDA vapor for 8h.
GLP compliance:
no
Remarks:
did not exist at that time
Test type:
other: Comparable to the traditional method (guideline did not exist at that time)
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylenediamine
EC Number:
203-468-6
EC Name:
Ethylenediamine
Cas Number:
107-15-3
Molecular formula:
C2H8N2
IUPAC Name:
ethane-1,2-diamine

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Remark on MMAD/GSD:
The study was carried out with vapors
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
2000 ppm corresponding to 4.9 mg/L and 4000 ppm corresponding to 9.8 mg/L
These concentrations are nominal concentrations; based on the vapor pressure of EDA, viz. 13 hPa at 20 deg. C, the maximum attainable vapor concentration is 13000 ppm, indicating that indeed EDA would have been present as vapor at the levels indicated.
No. of animals per sex per dose:
6 males per concentration
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Not required for this type of study

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC0
Effect level:
2 000 ppm
Exp. duration:
8 h
Sex:
male
Dose descriptor:
LC100
Effect level:
4 000 ppm
Exp. duration:
8 h
Sex:
male
Dose descriptor:
LC50
Effect level:
3 000 ppm
Exp. duration:
8 h
Remarks on result:
other: Geometric mean of LC0 and LC100
Sex:
male
Dose descriptor:
LC50
Effect level:
6 000 ppm
Exp. duration:
4 h
Remarks on result:
other: Calculated from 8h exposure using Haber's law
Mortality:
0% mortality at 1000 ppm, 100% mortality at 2000 ppm.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The 4-h LC50 value was calculated to be 6000 ppm corresponding to 14.7 mg/L.
Executive summary:

Six male rats per group were exposed to 2000 or 4000 ppm EDA vapour for 8h. Mortality of rats was observed for a 14 -day period. No deaths were observed in the 2000 ppm group, and 100% mortality was observed in the 4000 ppm group. Taking the geometric mean as the LC50 value, and calculating back to 4h exposure results in a 4 -h LC50 value of 6000 ppm corresponding to 14.7 mg/L.