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Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1954 or before
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Response of rats to repeated inhalation of ethylenediamine vapours
Author:
Pozzani UC, Carpenter CP
Year:
1954
Bibliographic source:
Ind. Hyg. Occup. Med. 9: 223-225

Materials and methods

Principles of method if other than guideline:
Four exposure groups of 30 rats (15 female/15 male) were exposed to EDA vapour. Each exposure group had a control group.
GLP compliance:
no
Remarks:
pre-GLP
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:
Sherman
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Chamber air was passed through an acidified glassbead adsorption tube. The captured Ethylenediamine was quantified by titration.

Target concentrations were 0, 60, 120, 240 and 480 ppm; analytical concentrations were: 0, 59, 132, 225 and 484 ppm; these correspond to 0, 146, 327, 558 and 1200 mg/m3
Duration of treatment / exposure:
6 weeks
Frequency of treatment:
7 h/day, 5 days/week
Doses / concentrationsopen allclose all
Dose / conc.:
60 ppm
Dose / conc.:
120 ppm
Dose / conc.:
240 ppm
Dose / conc.:
480 ppm
No. of animals per sex per dose:
15 male and 15 female per concentration
Control animals:
yes

Examinations

Sacrifice and pathology:
After termination the liver and kidney weights were recorded, and samples for histological examinations of liver, lung, heart, kidney adrenal gland and spleen were taken

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
132 ppm: slight depilation; 484 ppm: depilation was first observed on the 6th day of exposure
Mortality:
mortality observed, treatment-related
Description (incidence):
484 ppm: All rats died within 20 days of initial exposure at 484 ppm;
225 ppm: The death of 16/30 was substance-related and another 10 deaths were considered not to be substance-related
132 ppm: The death of 4/30 animals was attributed to lung infection (not substance-related)


132 ppm: The death of 4/30 animals was attributed to lung infection (not substance-related); slight depilation; body weight gain and relative weights of liver and kidney were not affected; no substance-related macroscopic or histologic changes.
225 ppm: The death of 16/30 was substance-related and another 10 death were considered not to be substance-related; the 4 rats which survived showed significantly lower weight gain and higher relative weights of liver and kidney; cloudy swelling of the liver and of the loop and convoluted tubules of the kidney; lung congestion was observed in exposed as well as in control rats in similar proportions. 484 ppm: All rats died within 20 days of initial exposure; depilation was first observed on the 6th day of exposure; cloudy swelling of the liver (in 23/28 animals), cloudy swelling and degeneration of convoluted tubules (in 7/28 animals); congestion of the lung (in 17/28 animals) and of the adrenal cortex (in 5/28 animals). 59 ppm: No effect on weight gain or organ weights. No depilation. No significant damage to examined tissues; lung, liver and kidney.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
59 and 132 ppm: body weight gain not affected
225 ppm: the 4 rats which survived showed significantly lower weight gain
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
59 and 132 ppm: relative weights of liver and kidney were not affected
225 ppm: the 4 rats which survived showed significantly higher relative weights of liver and kidney
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
59 and 132 ppm: no substance-related macroscopic changes
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
59 and 132 ppm: no substance-related histologic changes.
225 ppm: cloudy swelling of the liver and of the loop and convoluted tubules of the kidney; lung congestion was observed in exposed as well as in control rats in similar proportions
484 ppm: cloudy swelling of the liver (in 23/28 animals), cloudy swelling and degeneration of convoluted tubules (in 7/28 animals); congestion of the lung (in 17/28 animals) and of the adrenal cortex (in 5/28 animals).

Effect levels

Dose descriptor:
NOAEC
Effect level:
132 ppm (analytical)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: clinical signs; mortality, body weight; organ weights; and pathology at the next higher level of 225 ppm (558 mg/m3)

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEC in a 6-week inhalation study was 132 ppm (327 mg/m³); the slight depilation observed at this concentration level was considered to be of limited, if any, biological significance.
Executive summary:

In a 6 week study four exposure groups of 30 Sherman rats (15 female/15 male) were exposed to EDA vapour for 7 h /day for 5 days per week. Each exposure group had a control group. The NOAEC was 132 ppm (327 mg/m³).