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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:
1980-03-19 and 1980-05-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: according to the guideline of the United States Environmental Protection Agency (EPA)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Version / remarks:
1978
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
FAT 11181/A
IUPAC Name:
FAT 11181/A
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 to 3 kgs
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2
- Humidity (%): 55 + 10
- Photoperiod: 10 hours light cycle day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
The lids were gently closed togehter for a few seconds.
Observation period (in vivo):
24 h/ 48 h/ 72 h/ 4 d/ 7 d
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: In 3 of 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.

SCORING SYSTEM: according to the EPA score system

TOOL USED TO ASSESS SCORE: slit lamp

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
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
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: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
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: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
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

Any other information on results incl. tables

The cornea, iris, redness and chemosis scores of animals which received a washout are given in the following table.

Irritation parameter

Basis

Time point

Score

Max. score

Reversibility

Cornea score

Animal 4

24 h/ 48 h/ 72 h

0

4

 

Animal 5

0

 

Animal 6

0

 

Iris score

Animal 4

24 h/ 48 h/ 72 h

0

2

 

Animal 5

0

 

Animal 6

0

 

conjunctivae score

Animal 4

24 h/ 48 h/ 72 h

1

3

Fully reversible within 7 days

Animal 5

0.66

Fully reversible within 72 h

Animal 6

0.66

Fully reversible within 72 h

chemosis score

Animal 4

24 h/ 48 h/ 72 h

0.66

4

Fully reversible within 72 h

Animal 5

0.66

Animal 6

0.66

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU

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