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:
1990
Report Date:
1990

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: HOECHST AG, company breeding colony
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.0 - 3.6 kg
- Housing: AC, single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen ad libitum, 15 g hay per day
- Water (e.g. ad libitum): deionised, chlorinated water from an automatic water dispenser ad libitum

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 untreted right eye of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per eye
- Concentration (if solution): neat

VEHICLE: no
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 h after application and at all reading time points as long as discharges were observed

SCORING SYSTEM:

Cornea: 0-4
Iris: 0-2
Conjunctivae, redness: 0-3
Conjunctivae, chemosis: 0-4


TOOL USED TO ASSESS SCORE: fluorescein / UV-light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 79, 154, 155 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: # 79, 154, 155 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: # 79, 154, 155 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h after instillation
Irritation parameter:
chemosis score
Basis:
animal: # 79, 154, 155 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:
A clear, colourless discharge was observed in one of three animals. All signs of irritation/corrosion were fully reversible within 72 h.
Other effects:
No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not seriously eye damaging or 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 0.7 (three animals) for conjunctivae redness. All signes of irritation were fully reversible within 72 h.

All scores were below the threshold values for classification.