Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02. Jul 1956 - 24. Aug 1956
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documente report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1960
Report Date:
1960

Materials and methods

Principles of method if other than guideline:
Method: BASF-Test.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aethylendiamine; Laromin A 215
- Analytical purity: ca. 90%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals 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:
other: 24 h - 48 h - 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)
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.