Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report wich meets basic scientific principles, however with the following restriction: Minimal details on test animals were given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Principles of method if other than guideline:
BASF Test:
Several groups of 5 rats were treated by gavage with suspensions of the test substance in 0.5% Carboxylmethyl cellulose (CMC) aqueous preparation. Group-wise documentation of clinical signs was performed over the 14-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-bis(3-aminopropyl)ethylenediamine
EC Number:
234-147-9
EC Name:
N,N'-bis(3-aminopropyl)ethylenediamine
Cas Number:
10563-26-5
Molecular formula:
C8H22N4
IUPAC Name:
(3-aminopropyl)({2-[(3-aminopropyl)amino]ethyl})amine
Details on test material:
- Name of test material (as cited in study report): N-4-Amin
- Analytical purity: > 97 %

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: males 202 g, females 170 g (mean)
- Diet: Altromin R 124 (Altromin GmbH, Lage)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
647, 950, 1397, 2043, 3002 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
Probit analysis was used for the determination of the LD50.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 140 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 950 mg/kg bw < LD 50< 1397 mg/kg bw
Mortality:
3002 and 2043 mg/kg bw: all animals died
1397 mg/kg bw: all male animals and 4/5 female animals died
950 mg/kg bw: 1/5 males died, all females survived
647 mg/kg bw: all animals survived
Clinical signs:
Dyspnoea, poor general state, apathy, abdominal or lateral position, spastic gait, atonia, and diarrhoea were noted in the 1397, 2043 and 3002 mg/kg bw dose groups.
Body weight:
Body weight decrease was observed during the study.
Gross pathology:
Necropsy findings of the animals that died comprised erythema of the intestinal mucosa, acute congestive hyperemia and dilatation of the heart, acute cachexia.

Any other information on results incl. tables

Dose

(mg/kg bw)

 

Mortality

Dead/Treated

1 hour

24 hours

48 hours

7 days

14 days

male

female

male

female

male

female

male

female

male

female

647

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

950

0/5

0/5

0/5

0/5

0/5

0/5

1/5

0/5

1/5

0/5

1397

0/5

0/5

1/5

2/5

3/5

2/5

5/5

4/5

5/5

4/5

2043

0/5

0/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

3002

1/5

0/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

Applicant's summary and conclusion