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Toxicological information

Eye irritation

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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: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Physical state: liquid
- Analytical purity: > 83 %
- Lot/batch No.: B40071
- Stability under test conditions: The stability of the test substance was confirmed by reanalysis
- Storage condition of test material: room temperature, exclusion of light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., France
- Age at study initiation: 3-4 months
- Weight at study initiation: 2.65-2.80 kg
- Housing: individually
- Diet: ca. 130 g/animal/day (Kliba-Labordiät)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single application; substance was washed out after 24 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to OECD guideline 405

TOOL USED TO ASSESS SCORE: light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
2.56
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
2.11
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

The mean individual scores of the animals (24/48/72 hours) were:

corneal opacity: 1 in 3/3 animals

iris: 0 in 1/3 animals, 0.67 in 1/3 animals and 1.33 in 1/3 animals

redness of the conjunctivae: 2.33 in 1/3 animals; 2.67 in 2/3 animals

chemosis: 1.67 in 1/3 animals, 2.33 in 2/3 animals

Due to the overall and individual mean scores observed, the test substance has to be classified as irritating to eye (R36) according to EU- and as eye irritant Cat. 2A according to GHS-criteria.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Indication of an irritant property to the eye
Executive summary:

The potential of "confidential substance name" to cause damage to the conjunctiva, Iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 ml of the test substance according to OECD 405.

The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and then in weekly intervals until day 14.

Slight to severe conjunctival redness, slight to marked conjunctival swelling and slight to severe discharge were observed during the course of the study. Slight corneal opacity was observed in all animals and moderate or severe iritis was noted in two animals during the observation period.

The ocular reactions were reversible in all animals within 14 days after application. The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.6 for conjunctival redness and 2.1 for chemosis.