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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
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1987
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted 1984
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Laromer LR 8869
- Physical state: liquid, achromatic to slight yellowish
- Analytical purity: 99.8
- Purity test date: 02/1992
- Lot/batch No.: 1/92
- Stability under test conditions: proven by reanalysis
- Storage condition of test material: refrigerator, exclusion of light

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Age at study initiation: young adult females
- Weight at study initiation: 3.1 - 3 5kg
- Housing: individually in stainless steel cages with wire mesh walk floors (40 X 51cm)
- Diet (e.g. ad libitum): KLIBA lab diet 341 ad lib. (app. 130g/animal/day)
- Water (e.g. ad libitum): tap water ad lib. (app. 250ml/day)
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml

Duration of treatment / exposure:
once, substance not washed out
Observation period (in vivo):
8 days (study terminated after complete reversion of all effects)
observations after 1h, 24h, 48h, 72h, 8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
not washed out

SCORING SYSTEM: see additional information

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h - 8 days
Score:
0
Max. score:
2
Remarks on result:
other: no effects on the iris were observed
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 - 72h (mean)
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: #2+#3
Time point:
other: 24-72h (mean)
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24h - 72h (mean)
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal: #2 + #3
Time point:
other: 24 - 72h (mean)
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24h - 72h (mean)
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: #2 + #3
Time point:
other: 24h-72h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h (animal 2) or 8 days (animal 3)

Any other information on results incl. tables

Readings Animal Cornea   Iris Conjunctiva     Symptoms
    Opacity Area   Redness Swelling Discharge  
1h 1 0 0 0 3 1 2  
  2 0 0 0 2 1 2  
  3 0 0 0 2 1 2  
24h 1 0 0 0 2 0 0  
  2 1 4 0 3 2 2 SR, DB
  3 1 3 0 3 1 2 SR 
48h 1 0 0 0 1 0 0  
  2 1 3 0 3 1 1 SR
  3 1 2 0 3 1 1 SR
72h 1 0 0 0 0 0 0  
  2 1 3 0 3 1 1 SR
  3 1 2 0 2 1 0 SR
8 D 1 0 0 0 0 0 0  
  2 0 0 0 0 0 0 SR
  3 0 0 0 0 0 0 SR

SR: small retractions in the eyelids

DB: discharge of blood

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Under the test conditions chosen and considering the described findings, the test substance gives indication of an irritant property to the eye.
Executive summary:

The potential of the test substance to cause damage to the conjunctiva, iris, or cornea was assessed in 3 white Vienna rabbits, subjected to a single ocular application of 0.1ml of the test substance on day 0 . The average score (24 to 72h) for irritation was calculated to be 0.7 for corneal opacity, 0.0 for iris, 2.1 for conjunctivae redness, and 0.7 for chemosis. The findings were reversible in all animals within 8 days, thus the study was terminated.