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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PK 95/222

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerated

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, Biberach
- Age at study initiation: Young adult animals
- Housing: Single housing in fully air-conditioned rooms.
- Diet (ad libitum): Kliba-Labordiaet 341 (Klingentakmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day.
- Water (ad libitum): tap water, about 250 ml per animal per day.
- Acclimation period: for at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye.
Amount / concentration applied:
Each animal received a single application of 0.1 mL of undiluted test substance into the conjunctival sac of the right eye.
Duration of treatment / exposure:
24 h
Observation period (in vivo):
15 d and 21 d for animal 01
Number of animals or in vitro replicates:
6
Details on study design:
Prior to treatment, both eyes of the animals were examined for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used on the study.

REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 24 hours

SCORING SYSTEM: The assessment and scoring of the findings was based on the OECD Guideline 405 (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 15 or 21 d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 15 or 21 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48-72- h
Score:
2.1
Max. score:
3
Reversibility:
fully reversible within: 15 or 21 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 15 or 21 d
Irritant / corrosive response data:
The average score (24 to 72 h) for irritation was calculated to be 0.4 for corneal opacity, 1.0 for iris, 2.1 for conjunctivae redness and 1.7 for chemosis. The findings were reversible in all animals within 15 or 21 days after application, thus the study was terminated.

The mean values were calculated according to 93/21/EEC criteria (Apr. 27, 1993).

Please refer to "Any other information on results incl. tables" for individual scores.

Any other information on results incl. tables

The following table summarizes the individual observations

Animal

Readings

(hours)

Cornea

Iris

Conjunctivae

Symptoms

Redness

Chemosis

01

24

1

1

2

3

S, PC, DB, LC

48

1

1

2

3

SR, S, PC DB, LC

72

1

1

2

2

SR, S, PC DB, LC

Mean score

1.0

1.0

2.0

2.7

 

02

24

0

1

2

2

 

48

0

1

2

2

PC, DB

72

0

1

2

1

PC, DB

Mean score

0.0

1.0

2.0

1.7

 

03

24

1

1

2

2

 

48

1

1

2

2

PC, DB

72

1

1

3

2

PC, DB

Mean score

1.0

1.0

2.3

2.0

 

04

24

0

1

2

1

 

48

0

1

2

1

PC, DB

72

0

1

2

1

DB

Mean score

0.0

1.0

2.0

1.0

 

05

24

0

1

2

1

 

48

0

1

2

1

PC

72

0

1

2

1

PC

Mean score

0.0

1.0

2.0

1.0

 

06

24

0

1

2

2

 

48

1

1

2

2

PC, DB

72

1

1

2

2

PC

Mean score

0.7

1.0

2.0

2.0

 

SR: Small retraction in the eyelids

S: Suppuration

PC: Pupil contracted

DB: Dischrage of blood

LC: Loss of corneal tissue

Slight iritis observed in all rabbits was reversible within 8 days. No eye lesions remained in any animal at the end of the 3-week observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria