Clorofene

Eye irritation

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 guideline

Test guideline 1

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

Test guideline 2

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

not reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not reversible

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 12

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