Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.7%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.9 - 3.9 kg
- Housing: in single cages located in completely air conditioned rooms
- Diet: Altromin 2123 Haltungsdiat - Kaninchen, Altromin-GmbH, Lage/Lippe, ad libitum plus 15 g hay per day
- Water: deionized and chlorinated water from automatic dispensors ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50 +- 20
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye
Amount / concentration applied:
100 mg in the conjunctivae of the left eye
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: withphysiologic saline solution (37°C)
- Time after start of exposure: 24 hours

SCORING SYSTEM:
cornea: 0 - 4; iris: 0 - 2; conjunctivae: 0 - 3; chemosis: 0 - 4

TOOL USED TO ASSESS SCORE: UV hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the test results the substance has not to be classified for eye irritation.
Executive summary:

The susbstance was tested for eye irritarion according to OECD guideline 405. 3 New Zealand albino rabbits were administered 100 mg of the substance in the conjunctivae sack of the left eye. The untreated right eye was the control. 1 hour after removal the animals showed slight conjunctivae swelling and chemosis. But these symptoms were completely reversible after 24 hours.