Registration Dossier

Administrative data

Description of key information

Skin and eye irritation tests with rabbit shows that ethylene diamine is corrosive to skin and eye, there is no study available for determiantion of respiratory irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Principles of method if other than guideline:
Method: BASF-Test.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.65 and 3.47 kg
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


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

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.

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14. Nov 1977 - 22. Nov 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.
Principles of method if other than guideline:
Method: BASF-Test.
Observations after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach
- Weight at study initiation: 2.25 kg
- Diet: Ssniff-standarddiat/Kaninchen, ad libitum
- Water: ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline-control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h (no further data available)
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see detailed table in remarks on results.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h (no further data available)
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days

Findings:

animal1/animal2

 Time  Opacity  Iritis  Erythema Chemosis      
 1 h 3/3  0/0 2/2  2/2      
 24 h 3/3  0/0 2/2 2/2      
 48 h -/-  -/- -/- -/-      
 72 h #/# #/#   #/# 3/3      
 8 d #/#  #/# #/# 3/3      

-/-: The original readings at 48 h are missing.

#/# : A thick purlulence layer made an evaluation impossible.

1 h post application heavy opacity and distinct irritation of the mucous membrane were observed and bloody eye discharge occured. Grey discoloration of nictitating and mucous membrane. The severe corneal opacity is regarded to be irreversible.

The original BASF grading was converted into the numerical grading according the OECD Draize system.

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Ethylene diamine is corrosive to rabbit eye.
Executive summary:

Two Vienna White rabbits were exposed to 50 µl ethylene amine in one eye. Observations were made after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. Irreverible damage to eyes was reported.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the available data for skin corrosion, ethylene diamine is shown to be corrosive to skin. A 1min exposure showed necrosis at observation after 24h.

Irreversible damage to eye after exposure was shown in a study. Observations were made after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Ethylene diamine is classified as corrosive cat 1B to skin and corrosive to eye according to harmonised EU classification, and the available data supports this classification.