Ethylenediamine

Endpoint summary

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.

Categories Display