Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1978

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aethylendiamin
- Analytical purity: 99 %

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.