Ethylenediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 Apr - 12 Jun 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Materials and methods

Test guideline

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

Remarks:

Did not exist at that time

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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

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 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

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

Statistics:

Not required for this type of study

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

866 mg/kg bw

95% CL:

762 - 946

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

841 mg/kg bw

95% CL:

683 - 943

Effect levels 3

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:

other: See detailed table in remarks on results.

Body weight:

other body weight observations

Remarks:

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

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The combined LD50 value 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. A combined (males/females) LD50 value of 866 mg/kg was estimated on the basis of the observed mortalities.