(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

May 1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Version / remarks:

Nov 1982

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

EC Number:

406-850-2

EC Name:

(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

Cas Number:

133855-98-8

Molecular formula:

C17 H13 Cl F N3 O

IUPAC Name:

1-{[(2R,3R)-3-(2-chlorophenyl)-2-(4-fluorophenyl)oxiran-2-yl]methyl}-1H-1,2,4-triazole

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach (Main)
- Age at study initiation:
- Weight at study initiation: male: 3.10kg, female: 2.99kg
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area 40x51 cm
- Diet (e.g. ad libitum): Kliba 341, 4MM, Klingentalmuehle AG, 130g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 10-24°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Test system

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml bulk volume (about 31 mg of the comminuted test substance)
- Concentration (if solution):

Duration of treatment / exposure:

Single application of the conjunctival sac of the right eyelid. The substance was not washed out.

Observation period (in vivo):

72 h. Readings at 1 h, 24 h, 48 h, and 72 h

Number of animals or in vitro replicates:

3 male and 3 female animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM:
Scale for scoring ocular lesions:
Chemosis and cornea opacity: 0=none, 1=well-defined, 2=severe, 4= very severe
Conjunctivae redness: 0=normal, 1=slight, 2=well-defined, 3=severe
Iris: 0=normal, 1=circum-corneal injection, 2=iritis
Discharge: 0=normal, 1=slightly increased, 2=clearly increased, 3=distinctly increased

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Any other information on results incl. tables

Table 1: Results acute eye irritation

 

 

Readings	Animal	Sex	Cornea		Iris	Conjunctiva			Symptoms
			OP	AR		Red	Sw	DI
1 h	1 2 3 4 5 6	F M M F M F	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	1 1 1 1 0 0	0 0 0 0 0 0	0 1 1 1 1 1
24 h	1 2 3 4 5 6	F M M F M F	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	2 1 2 2 0 0	0 0 0 0 0 0	0 1 0 0 0 0
48 h	1 2 3 4 5 6	F M M F M F	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	1 1 1 1 0 0	0 0 0 0 0 0	0 1 0 0 0 0
72 h	1 2 3 4 5 6	F M M F M F	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0
Mean	1 2 3 4 5 6	F M M F M F	0.0 0.0 0.0 0.0 0.0 0.0		0.0 0.0 0.0 0.0 0.0 0.0	1.0 0.7 1.0 1.0 0.0 0.0	0.0 0.0 0.0 0.0 0.0 0.0
Mean			0.0		0.0	0.6	0.0

           OP=Opacity-degree of density; Sw=Chemosis; AR=Area of cornea involved; DI=Discharge; Red=Conjunctivae redness

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test item does not show eye irritating properties and has not to be classified for eye irritation.

Executive summary:

The substance was tested for its eye irritating potenital. The test method was based on EPA (FIFRA) and OECD 405 guidelines. GLP requirements were fulfilled. 0.1ml of the comminuted test substance was applied once to the eyes of 3 male and 3 female white Vienna rabbits. 1 hour after applciation slight redness and slightly increased discharge of the conjunctivae occurred. The symptoms were observed for a period of 48h. After 72h the reversibility could be demonstrated.