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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:
From June 7 to July 5, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
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: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-88397 Biberach
- Weight at study initiation: between 2040 to 2340 g
- Housing: housed individually in metal cages
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ° C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg was placed into the conjunctival sac of the left eye
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 277/M, 570/F, 468/F
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No ocular effects observed
Irritation parameter:
iris score
Basis:
animal: 277/M, 468/F
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No ocular effects observed
Irritation parameter:
iris score
Basis:
animal: 570/F
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
REDNESS
Basis:
animal: 277/M
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
REDNESS
Basis:
animal: 570/F
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
REDNESS
Basis:
animal: 468/F
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 277/M, 468/F
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: 570/F
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation
Conclusions:
Not irritating
Executive summary:

Method:

The eye irritation was determined in an irritation test on rabbits according to OECD Guideline 405 and EU Method B.5.

Observation:

Under the experimental conditions employed the test substance induced reactions of the iris and conjunctiva when instilled into the conjunctival sac of albino rabbit eyes. These effects are fully reversible within 7 days and the mean value of the readings 24 to 72 hours after instillation are below the threshold of significance.

 

Result:

Not irritating