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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: 1 male, 2 females
- Weight at study initiation: male : 3.0 kg, females: 2.7 - 2.9 kg
- Housing: Individually in stainless steel cages (35.5 x 55.5 x 45 cm)
- Diet: Pelleted standard Kliba 341, Batch 62/91 rabbit maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40 -70
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12 (music during the light period

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.1 g


Duration of treatment / exposure:
The eyelids were held together for about one second. The test substance was not washed out.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 male
2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to the OECD score system

TOOL USED TO ASSESS SCORE: hand-slit lamp 30 SL/M (C. Zeiss AG, Zuerich /Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel /Switzerland)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
4
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h/48 h/ 72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: not rinsed

Any other information on results incl. tables

No necropsy was performed in the animals euthanized at termination of observation. No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occured. The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not eye irritant
Executive summary:

The study was performed according to OECD guideline 405 and EU Method B.5, in three New Zealand rabbits (1 male, 2 females).

0.1 g of the test substance (60% act. integr.) was placed in the left eye of each animal and the lids were gently held together for about one second. The eyes of each animal were exmamined for ocula irritation 1, 24, 48, 72 hours, 7, 14 and 21 days after administration.

No necropsy was performed in the animals euthanized at termination of observation. No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occured. The body weight gain of all rabbits was similar. The mean scores (over time points 24 h, 48 h, 72 h) for animal 1 were determined to be 0.0 for cornea, 0.0 for iris, 1.0 for conjunctivae redness and 0.0 for chemosis. For animal 2, the mean scores were 0.33 for cornea, 0.0 for iris, 1.0 for conjunctiva redness and 0.33 for chemosis. For animal 3, the mean scores were 0.0 for cornea, 0.0 for iris, 1.0 for conjunctiva redness and 1.0 for chemosis. The observed effects were fully reversible within the 21 -day observation period.