4,6-diphenyl-1,3,5-triazin-2(1H)-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 Mar - 13 Apr 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 1981)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Hydroxy-4,6-diphenyl-1,3,5-triazin

IUPAC Name:

2-Hydroxy-4,6-diphenyl-1,3,5-triazin

Details on test material:

Test article: FAT 92376/A
Additional specification: 2-Hydroxy-4,6-diphenyl-1,3,5-triazin
Batch No: 10.26
Physical state: white crystals
Analytical purity: 98%
Storage conditions: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand white (Chbb:NZW)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: 1 male and 2 female New Zealand white rabbits (Chbb:NZW) from Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: no data
- Weight at study initiation: 2690 - 2780 g
- Housing: single housing in metal cages
- Diet: standard rabbit pellet (Nafag No 814, Gossau, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 30-70%
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml/55 mg

Duration of treatment / exposure:

Not applicable (Single dosing without rinsing)

Observation period (in vivo):

72 h (eye reactions were reversible until the end of observation period)

Number of animals or in vitro replicates:

3 (1 male, 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE: No washing performed.

SCORING SYSTEM: Draize scheme

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no findings

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: no findings

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

No effects in the untreated eyes of the rabbits were observed. No effects on cornea or iris were observed in the three animals after 1, 24, 48, and 72 h. After 1 h redness (up to score 2) and chemosis (up to score 1) was observed. After 24 h again redness (up to score 1) and chemosis (up to score 1) was observed. The effects were fully reversible within 48 h after beginning of the treatment.

Any other information on results incl. tables

Table 1: Individual eye scores of the three rabbits at 1, 24, 48, and 72 h after beginning of the treatment.

Animal			conjunctivae
	cornea	iris	redness	Chemosis
075/M
1 h	0	0	2	1
24 h	0	0	1	1
48 h	0	0	0	0
72 h	0	0	0	0
Mean (24-72 h)	0	0	0.33	0.33
000/F
1 h	0	0	2	1
24 h	0	0	1	0
48 h	0	0	0	0
72 h	0	0	0	0
Mean (24-72 h)	0	0	0.33	0
060/F
1 h	0	0	1	1
24 h	0	0	1	1
48 h	0	0	0	0
72 h	0	0	0	0
Mean (24-72 h)	0	0	0.33	0.33

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information