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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment. For read across justification please refer to IUCLID chapter 13.

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 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only one dose level
GLP compliance:
no
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
Details on test material:
- Name of test material (as cited in study report): N-Mono-(aminopropyl)1,2-diaminoaethan (N-3-Amin)
- Analytical purity: 98 %

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 3,29 kg (mean); female: 3,44 kg (mean)



Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done):

TEST MATERIAL
- Concentration (if solution): 100 %


Duration of exposure:
once
Doses:
200 µl/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
184 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Calculated from 0.2 ml/kg assuming test substance density of 0.92 g/ml
Mortality:
2 male animals and 1 female animal died after 7 days.
Clinical signs:
other: slight apathy in all animals, apathy in 3 animals, urine tinged with blood in 3 of the 3 animals that died
Gross pathology:
- Animals that died spontaneously: Kidney (renal pelvis and urinary bladder filled with blood); Liver (focal mass necroses); lung (severe edema); heart (dilatation bilaterally)
- Animals sacrificed after 14 days: no adverse effects observed
Other findings:
Necrosis was observed in all animals

Any other information on results incl. tables

Mortality

 Dose (µl/kg)  Conc. (%)  No. of Animals died within1 h  24 h  48 h  7 d  14 d
 200  100  3 male  0/3  0/3  0/3  2/3  2/3
 200  100  3 female  0/3  0/3  0/3  1/3  1/3

Applicant's summary and conclusion