2-phenylimidazole

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 Jan - 03 Feb 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

only 50 µL instilled, only 2 animals used, 72-hrs reading missing, observation period only 8 days

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

The eye irritant potential of the test substance was investigated according to an internal available testing protocol at the testing facility.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-phenylimidazole

EC Number:

211-581-7

EC Name:

2-phenylimidazole

Cas Number:

670-96-2

Molecular formula:

C9H8N2

IUPAC Name:

2-phenyl-1H-imidazole

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.33 kg (female) and 2.24 kg (male)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Talcum powder was used as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 50 µL

Observation period (in vivo):

8 days
Reading time points: 10 min, 1, 3, 24 and 48 h, 5, 7 and 8 days

Number of animals or in vitro replicates:

1 male and 1 female

Details on study design:

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of both animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of both animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of both animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

At the 1-h reading time point residues of the test substance and slight redness of the treated eye were observed in both animals. At the 24-h reading time point slight redness (score 1) were observed in both animals and in the female the eyes appeared smeary. The findings in the female were fully reversible within 48 h and in the male within 8 days, respectively. Redness was the only effect which was mentioned in the study report, therefore the conclusion can be made that the cornea opacity score, iris score and chemosis score was 0 in both animals.

Any other information on results incl. tables

Table 1: Results of eye irriation study

Observation time	Rabbit no.
	1 (female)	2 (male)
	Conjunctivae	Conjunctivae
24 h	1	1
48 h	0	1
72 h	No experimental data available; for calculation of mean scores, the 72 h values were assumed to be the same as those at 48 h (worst case assumption)
Mean value 24 + 48 + 72 h*	0,3	1,0

*No 72 h data are available: for calculation of mean scores, the 72 h values were assumed to be the same as those at 48 h (worst case assumption: persistence of effects seen at 48 h over 72 h).

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

Based on the results of the conducted study, no irritant potential towards the eyes of a female and a male rabbit were observerd after instillation of the test substance.
CLP: not classified