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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:
7 - 14 Dec 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The non-GLP study was performed equivalent to an appropriate OECD guideline. Only 10% (a.i.) was used in the study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Journal Officiel de la Republique Francaise (1992)
Deviations:
yes
Remarks:
Only 10% (a.i.) tested, limited study design information
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: fluid gel, not further specified

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
other: distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: 55% product diluted to 18.2%, (i.e. 10% a.i.)
Duration of treatment / exposure:
Single application with washing after 30 sec (right eye)
Single application without washing (left eye)
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48, 72 h and 4 and 7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the eyes was only performed on the right eye 30 sec after application of the test material. The left eye remained unwashed.
- Time after start of exposure: 30 sec

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Corneal opacity was noted in 2/3 animals (grade 11) 1 h after application of the test material.24 h after application of the test material corneal opacity was observed in 3/3 animals (grade 2). These effects were fully reversible within 4 days (1/3 animals) and 7 days (2/3 animals), respectively. Iris effects (grade 1) were recorded in 1/3 animals 24 h after application of the test material, but being fully reversible within 48 h. Conjunctivae effects (grade 1) were observed in 3/3 animals 1 h, 24, 48 and 72 h after application of the test material. These effects were fully reversible within 4 days (2/3 animals) and 7 days (1/3 animals), respectively. Chemosis was observed in 1/3 (grade 1) and 2/3 (grade 2) animals 1 h after application of the test material, but these effects were fully reversible within 72 h (2/3 animals with initially grade 2) and 4 days (1/3 animals with initially grade 1).
Other effects:
No mortalities occured during the study period.

Any other information on results incl. tables

Table 1: Individual scores for corneal opacity, iris, conjunctivae and chemosis effects

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

chemosis

1

 

 

 

 

1

1

1

0

0

24

1

1

0

2

48

1

1

0

2

72

1

1

0

2

average

1

1

0

2

2

 

 

 

 

1

1

2

0

1

24

1

1

0

2

48

1

1

0

2

72

1

0

0

2

average

1

0.67

0

2

3

 

 

 

 

1

1

2

0

1

24

1

1

1

2

48

1

1

0

2

72

1

0

0

2

average

1

0.67

0.33

2

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the experimental conditions performed equivalent or similar to OECD TG 405 the test material appeared to be irritating to eyes when applied as 10% (a.i.) formulation.

SCL (worst case assumption due to lack of data for neat substance):
Eye Irrit. Cat. 2 ≥1% (a.i.) and ≤10% (a.i.)
Eye Dam. Cat. 1 >10% (a.i.)