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Description of key information

LD50/LC50 values are based on animal test data for acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10. Apr 1979 - 12. Jun 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 230 g (mean); female: 188 g (mean)
- Fasting period before study: 15 - 20 h before administration
- Diet (e.g. ad libitum): Herlian MRH, Eggersmann KG
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 3.16 - 14.70 %

MAXIMUM DOSE VOLUME APPLIED: 10 ml

Doses:
316, 464, 681, 825, 1000, 1210, 1470 mg/kg
No. of animals per sex per dose:
316, 464, 681 mg/kg: 5
825, 1000, 1210, 1470 mg/kg: 10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 3, 7, 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
866 mg/kg bw
95% CL:
762 - 946
Sex:
male
Dose descriptor:
LD50
Effect level:
841 mg/kg bw
95% CL:
683 - 943
Sex:
female
Dose descriptor:
LD50
Effect level:
893 mg/kg bw
95% CL:
750 - 943
Mortality:
1470 mg/kg: all animals died within 24 h
1210 mg/kg: 8 males and females each died within 24 h. 1 further male died within 48 h.
1000 mg/kg: 7 males and 6 females died within24 h. 1 further male and female died within 48 h.
825 mg/kg: 5 males and females each died within 24 h. 1 further male died within 48 h.
681, 464, 316 mg/kg: no mortality occured.
Clinical signs:
See detailed table in remarks on results.
Body weight:
Initially, animals in the 1210, 825 and 681 mg/kg dose group lost weight. See detailed table in remarks on results.
Gross pathology:
Dead animals:
Heart: acute dilatation on the right side; acute congestion;
Stomach: diffuse reddening of the glandular stomach;
Intestine: in individual animals diarrhoeic content; atonic; reddened in several cases;
Liver: in some animals individual focal necrosis;
Thymus: in individual animals extensive hemorrhages.

Sacrificed animals:
Stomach: in several animals wall of the forestomach slightly indurated. In individual cases adhesion of the forestomach to the liver.

Mortality:

 Dose (mg/kg)  1 h     24 h     48 h     14 days   
   male  female male   female  male  female  male  female
 1470  0/10  0/10  10/10  10/10  10/10 10/10  10/10  10/10 
1210  0/10 0/10  8/10  8/10  9/10  8/10  9/10  8/10
 1000  0/10  0/10  7/10  6/10  8/10  7/10  8/10  7/10
  825  0/10  0/10  5/10  5/10  6/10  5/10  6/10  5/10
  681  0/5  0/5  0/5 0/5  0/5   0/5  0/5  0/5
  464  0/5  0/5 0/5   0/5  0/5  0/5  0/5  0/5
  316  0/5  0/5  0/5  0/5  0/5 0/5  0/5   0/5

Mean weight (g):

 Dose (mg/kg)  gender  day 0  day 2-4  day 7  day 13  
 1470  male 140 154 196 235  
   female 175  -  -  -  
 1210  male 220 200 234 271  
   female 190 195 212 226  
 1000  male 250 221   247   281   
   female 195 175   186   204   
 825  male 220  214   230   271   
   female 190 166   192   212   
 681  male 300 298 327 349  
   female 210 212 227 205  
 464  male 300 305 340 370  
   female 220 226 240   249   
 316  male 180 205 244  290  
   female 160 172 189 204  

Clinical signs: symptoms occured in the indicated time:

 Dose  1470 mg/kg  1210 mg/kg  1000 mg/kg  825 mg/kg  681 mg/kg  464 mg/kg  316 mg/kg
 Dyspnea  15 min - 5 h  - 1 d - 1 d  15 min - 1 d  30 min - 5 h  5 h  -
 Spasmodic respiration  -  15 min - 4 h  2 h - 4 h  2 h  -  -  -
 Apathy  15 min - 1d  - 1 d  - 3 d  15 min - 3 d  15 min - 5 h  1 h - 5 h  -
 Abnormal position  5 h  -  -  - -    -  -
 Staggering  15 min - 5 h  - 4 h  15 min - 1 d  15 min - 1 d  15 min - 1 d  1 h - 5 h  -
 Spastic gait  15 min - 1 d  - 1 d 15 min - 3 d  15 min - 3 d  15 min - 1 d  1 h - 1 d  -
 Urine (orange/yellow)  -  1 d - 2 d  4 h - 3 d  1 d - 3 d  4 h - 3 d  4 h - 1 d  -
 Piloerection  30 min - 2 d  - 1 d  30 min - 3 d  15 min - 3 d  1 h - 5 h  2 h - 5 h  -
 Diarrhea  4 h - 5 h  4 h - 1 d  4 h - 1 d  2 h - 1 d  4 h - 1 d  4 h - 5 h -
 Cyanosis  2 h - 4 h  -  -  -  -  -  -
 Exsiccosis  4 h  4 h - 1 d  1 d  2 h - 1 d  -  -  -
 Salivation  -  -  2 h - 4 h  -  -  -  -
 Blood in feces  -  -  5 h  -  5 h  5 h  -
 Poor general condition  15 min - 1 d  - 1 d  - 3 d  15 min - 3 d  15 min - 1 d 1 h - 5 h   -
               

min: minute; h: hour; d: day

There is indication that the test substance causes local irritation to exposed tissues.

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Harmful Criteria used for interpretation of results: EU
Conclusions:
LD50 in an acute oral toxicity test to rats was 866 mg/kg bw.
Executive summary:

In an acute toxicity test on rats, test groups consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior treatment and thereafter, day 3, day 7 and day 13 post-treatment. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. An LD50 value of 866 mg/kg was estimated on the basis of the observed mortalities.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
866 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study which meets basic scientific principles.
Qualifier:
no guideline followed
Principles of method if other than guideline:
14 day mortality of rats exposed to metered concentrations of EDA vapor for 8h.
GLP compliance:
no
Species:
rat
Strain:
not specified
Sex:
male
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
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
No. of animals per sex per dose:
6 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
male
Dose descriptor:
LC0
Effect level:
4.9 mg/L air
Exp. duration:
8 h
Sex:
male
Dose descriptor:
LC100
Effect level:
9.8 mg/L air
Exp. duration:
8 h
Sex:
male
Dose descriptor:
LC50
Effect level:
7.35 mg/L air
Exp. duration:
8 h
Remarks on result:
other: Geometric mean of LC0 and LC100
Sex:
male
Dose descriptor:
LC50
Effect level:
14.7 mg/L air
Exp. duration:
4 h
Remarks on result:
other: Back calculated from 8h exposure using Habers law
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute inhalation LC50 was 14.7 mg/l.
Executive summary:

Rats were exposed to metered concentrations of EDA vapor for 8h. Six male rats per dose group were exposed to 2000 and 4000 ppm EDA vapour for 8h. Mortality of rats was observed for a 14 day period. No deaths were observed in the 2000 ppm dose group, and 100% mortality was observed in the 4000 ppm dose group. Taking the geometric mean as the LC50 value, and calculating back to 4h exposure gives an LC50 of 14.7 mg/l

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
14 700 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study which meets basic scientific principles.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Concentrated and 10% water solution was applied to clipped rabbit trunk under Vinylite sheeting.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Sex:
male
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
0.5 - 0063 - 0.795 - 1 mg/kg of concentrated sample
10% solutions 1.20 - 1.52 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Sex:
male
Dose descriptor:
LD50
Effect level:
560 mg/kg bw
Sex:
male
Dose descriptor:
approximate LD50
Effect level:
ca. 1 520 mg/kg bw
Remarks on result:
other: In 10% diluted solution

Necrosis of the skin, congestion of the lungs and damage to the abdominal organs was noted on autopsy.

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 in an acute dermal toxicity test on rabbit was 560 mg/kg.
Executive summary:

Rabbits were exposed to concentrated ethylene diamine (76%) and a 10% dilution in water under occlusive coverage for 24 h. With the concentrated substance, severe skin damage occurred. Congestion of the lungs and damage to the abdominal organs was noted on autopsy. LD50 was 560 mg/kg bw. For the diluted samples LD50 was approximately 1520 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
560 mg/kg bw

Additional information

In an acute inhalation toxicity test, an 8h LC50 value was calculated as the geometric mean of LC0 and LC100 values. Back calculation using Habers law, C*t =k, gives the 4h LC50 value of 14.7 mg/L. This is supported by another study, with an 8h LC0 value of 11 mg/L.


Justification for selection of acute toxicity – oral endpoint
As a worst case the lowest LD50 was selected

Justification for selection of acute toxicity – inhalation endpoint
This is the only study where mortalities have been observed

Justification for classification or non-classification

A classification for Acute oral toxicity cat IV, acute dermal toxicity catIII and acute inhalation toxicity cat IV is proposed.