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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:
24 - 27 Jun 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
temperature: 16°C (10- 25°C acceptable range) instead of 20+/-3°C; artificial light: 10 h dark / 14 h light instead of 12 h dark / 12 h light; no anesthetics/analgesics; directly 3 animals tested instead of 1 animal in the initial test
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
temperature: 16°C (10 - 25°C acceptable range) instead of 20+/-3°C; artificial light: 10 h dark / 14 h light instead of 12 h dark / 12 h light
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Clorofene
EC Number:
204-385-8
EC Name:
Clorofene
Cas Number:
120-32-1
Molecular formula:
C13H11ClO
IUPAC Name:
clorofene

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Morton Commercial Rabbits, Parsonage Farm, Stansted, England
- Age at study initiation: approximately 3 months
- Weight at study initiation: 2.90 - 3.02 kg
- Housing: individually in suspended galvanised steel cages (55 x 48 x 40 cm), mesh floors
- Diet: S.Q.C. Rabbit Standard, pelleted (Special Diet Services Limited), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 (10 - 25 acceptable limits)
- Humidity (%): 50
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 10 / 14

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize; additional assessment of pain response

TOOL USED TO ASSESS SCORE: pencil beam torch / ophthalmoscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Irritation responses evident as diffuse opacity or translucency of the whole visible corneal surface, injection of the conjunctival blood vessels and eversion of the eyelids due to moderate chemosis became more marked at each subsequent examination and culminated in a state of severe ocular irritation 4 days after treatment. At this time there was an ocular discharge, the conjunctivae had a beefy-red appearance, the eyelids were everted by moderate chemosis, the whole surface of the cornea was opalescent and the colour of the iris indicated marked congestion of that tissue. In addition, areas of ulceration had exposed part of the corneal stroma of 2 rabbits. After consideration of the deteriorating condition of the treated
eye, particularly the cornea, the study was terminated 72 h after treatment.

Any other information on results incl. tables

Table 1: Grades of ocular irritation responses following instillation of Chlorophen

Region of the eye

Response

Grade of response at time after instillation

1 h

24 h

48 h

72 h

Animal #1

Cornea

Opacity

1

2

3

3

Area

4

4

4

4

Iris

Value

0

1

1

1

Conjunctiva

Redness

1

2

3

3

Chemosis

2

2

2

2

Discharge

0

2

2

2

Animal #2

Cornea

Opacity

2

3

3

3

Area

4

4

4

4

Iris

Value

0

0

1

1

Conjunctiva

Redness

1

2

3

3

Chemosis

2

2

2

2

Discharge

0

2

3

2

Animal #3

Cornea

Opacity

2

2

3

3

Area

4

4

4

4

Iris

Value

0

1

1

1

Conjunctiva

Redness

1

2

3

3

Chemosis

2

1

1

2

Discharge

0

1

1

2

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
CLP: Eye Dam. 1, H318