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Toxicological information

Acute Toxicity: oral

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethylendiamine
- Analytical purity: 99 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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

Administration / exposure

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

Results and discussion

Effect levelsopen allclose all
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.