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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data are given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Method: BASF-test
According to OECD guideline 402, a limit test at requires one dose level of at least 2000 mg/kg bodyweight in
a group of 5 male and 5 female animals.
The test described here used one dose level of 200 mg/kg.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethylenediamine
EC Number:
203-702-7
EC Name:
Trimethylenediamine
Cas Number:
109-76-2
Molecular formula:
C3H10N2
IUPAC Name:
propane-1,3-diamine

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Zuchtbetrieb: M.GAUKLER, 6050 Offenbach
- Weight at study initiation: 2.9 kg (in average)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The fur was removed from the dorsal and lateral trunk by electrical hair clipper about 15 to 24 h before application.
Only animals with healthy and intact skin were exposed (treated area: 50 cm2).
The dose is retained beneath for 24h an aluminium foil fixed by adhesive tapes.
Thereafter, excess fluid was removed.
Duration of exposure:
24 h
Doses:
200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy was conducted on decedents and sacrificed survivors.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 200 mg/kg bw
Based on:
test mat.
Mortality:
1h: males: 0/5; females: 0/5
24h: males: 0/5; females: 0/5
48h: males: 0/5; females: 1/5
7d: males: 1/5; females: 1/5
14d: males: 2/5; females: 1/5
Clinical signs:
Apathy
Accelerated breathing and dyspnea
Blood in urine and faeces

Local irritations: Necrosis in all animals 24h after application.
Gross pathology:
Victims: Heart: Acute dilatation, right; acute stasis hyperemia. Bladder: Bloody content (2); Kidney: Renal pelvis enlarged (1), coloured like sand (1); Liver: Discolorations
Survivors: No substance related findings.

Any other information on results incl. tables

Based on the available data, the LD50 was defined according to a DOT-guidance; an exact value was not provided.

Applicant's summary and conclusion