Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Madörin AG, Füllingsdorf, Schweiz
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.4 - 3.1 kg
- Housing: AC, single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water from an automatic water dispenser system

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated right eye of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiol. saline (37°C)
- Time after start of exposure: 24 after application

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

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: fluorescein, ultraviolet light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable owing to lack of effects
Irritation parameter:
iris score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable owing to lack of effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable owing to lack of effects
Irritant / corrosive response data:
1 h after application: yellow discharge (coloured by test item), which was fully reversible within 24 h
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not serious eye damaging and not eye irritating.

Findings do not meet criteria for classification according to Regulation (EC) No 1272/2008.
Executive summary:

The primary eye irritation potential of the test item was investigated according to OECD guideline 405. The test item (0.1 g) was applied to the intact eye of each of three New Zealand White rabbits. 24 h after application the eyes were rinsed with physiol. saline. The scoring of eye reactions (cornea, iris, conjunctivae redness, conjunctivae chemosis) was performed 1, 24, 48 and 72 h after instillation of the test item. Mean scores were calculated for each animal following grading at 24, 48 and 72 h after instillation of the test material.

The individual mean scores calculated across the scoring times (24, 48 and 72 h after instillation of the test material) were 0.0 (three animals) for cornea, iris and conjunctivae chemosis and 0.3 (two animals) or 0.7 (one animal) for conjunctivae redness. All signes of irritation were fully reversible within 48 h.

All scores were below the threshold values for classification.