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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: well performed OECD and GLP 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)
Version / remarks:
updated Guideline, adopted 24th february 1987
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test item contains about 38 % water. Reason is that this compound is manufacturer and further processed only as water wet substance.
It is not expected that the additional amount of water has an influence on the results.

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 breed
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.2-4.0 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, Altromin GmbH, ad libitum and hay 15 g per day
- Water (e.g. ad libitum): deionized, chlorinated water from automatic feeder, ad libitum

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right untreated 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:
single application / washing with physiol. saline (37°C) 24 hrs after application of test substance
Observation period (in vivo):
1, 24, 48 and 72 hrs post application
Number of animals or in vitro replicates:
3
Details on study design:
- washing with physiol. saline (37°C) 24 hrs after application of test substance and all following observations where eyes show secretion or coronea was examined

- Tools to assess score: fluorescin

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.7
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hrs
Score:
1.3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.7
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.7
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test the test substance is not eye irritating
Executive summary:

The test substance was tested for eye irritating properties according to OECD 405. Following these protocol 100 mg of the undiluted test substance were applied into the conjunctival sac of the left eye of 3 rabbits. The right eye remained untreated and served as a control. 24 h after instillation eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, and 72 h after test substance application. Mean scores (mean of 24, 48, 72h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.

Mean scores for all irritation parameters were below threshold values and were fully reversible within 72h.

Based on the findings in this test, the test substance is not eye irritating.