Registration Dossier
Registration Dossier
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EC number: 203-468-6 | CAS number: 107-15-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02. Jul - 24. Aug 1956
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 960
- Report date:
- 1960
Materials and methods
- Principles of method if other than guideline:
- Method: BASF-Test.
- GLP compliance:
- no
- Remarks:
- did not exist at that time
Test material
- Reference substance name:
- Ethylenediamine
- EC Number:
- 203-468-6
- EC Name:
- Ethylenediamine
- Cas Number:
- 107-15-3
- Molecular formula:
- C2H8N2
- IUPAC Name:
- ethane-1,2-diamine
- Details on test material:
- - Name of test material (as cited in study report): Aethylendiamine; Laromin A 215
- Analytical purity: ca. 90%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.65 and 3.47 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- 1, 5 and 15 min
- Observation period:
- 5 weeks
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol (conc.) and Lutrol/water (1:1)
- Time after start of exposure: After the exposure time: 1, 5 and 15 min
Results and discussion
In vivo
Results
- Irritation parameter:
- erythema score
- Remarks:
- 1 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- necrosis
Any other information on results incl. tables
Mean erythema score after 24, 48 and 72 h (animal1/2)
| Exposure time | 24 h | 48 h | 72 h | |||||
| 1 min | 3/3 | 3/3 | 3/3 | |||||
| 5 min | 3/3 | 3/3 | 3/3 | |||||
| 15 min | 3/3 | 3/3 | 3/3 | |||||
Already a 1 min exposure with ethylenediamine caused necrosis to the exposed skin.
The original BASF grading was converted into the numerical grading according the OECD Draize system.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Ethylene diamine is corrosive to rabbit skin
- Executive summary:
In a skin irritation/corrosion test, Vienna White rabbits were exposed to ethylene diamine.Two animals were treated for 1, 5 and 15 min using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time the skin was washed with Lutrol (conc.) and Lutrol/water (1:1). The animals were observed for 14 days and skin changes were recorded daily. Ethylene diamine is corrosive to rabbit skin.
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