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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976 - 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Method: BASF-Test, see details in the section "Any other information on materials and methods incl. tables".
GLP compliance:
no
Remarks:
study was performed prior to GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2-aminoethyl)-1,3-propanediamine
EC Number:
236-882-0
EC Name:
N-(2-aminoethyl)-1,3-propanediamine
Cas Number:
13531-52-7
Molecular formula:
C5H15N3
IUPAC Name:
N1-(2-Aminoethyl)-1,3-propanediamine

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: 196 g (mean); female: 166 g (mean)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4.64 % - 46.4 % in aqua. dest
Doses:
4640, 1470, 1000, 681, 464 µL/kg bw (corresponding to 426.9, 626.5, 920.0, 1352.4 and 4268.8 mg/kg bw, calculated assuming test substance density of 0.92 g/mL)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
Not indicated.

Results and discussion

Preliminary study:
Probit analysis
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
654 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Calculated from 0.7 mL/kg assuming a test substance density of 0.92 g/mL
Mortality:
All animals of the lowest dose group (426.9 mg/kg bw) survived (males: 0/5; females: 0/5). In the following dose group (626.5 mg/kg bw) no male animals died (0/5), but female animals (4/5). In higher dose groups (920.0 and 1352.4 mg/kg bw) mortality was also observed (males: 4/5 and 5/5; females: 4/5 and 4/5). No animals survived in the highest dose group (4268.8 mg/kg bw).
Clinical signs:
other: Dyspnea, apathy, abdominal position, lateral position, stagger, atonia, tremor, reduced general condition, diarrhoe, spasctic gait as well as initial body weight loss partially or in some animals of all but the low dose group
Gross pathology:
Heart dilation, congestive hyperemia in the heart , atonic and dilated stomach, diffuse erythema in the gastro-oesophageal vestibule, as well as dilated gut with bloody diarrhea were observed partially or in all animals of all but the low dose group.

Any other information on results incl. tables

Mortality

 Dose (µl/kg)  Conc. (%)  male animals  femal animals
 4640  46.4  5/5  5/5
 1470  14.7  5/5  4/5
 1000  10  4/5  4/5
 681  6.81  0/5  4/5
 464  4.64  0/5  0/5

Applicant's summary and conclusion