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EC number: 606-251-8 | CAS number: 1917-44-8
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:
- 1 993
- 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
- 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
Constituent 1
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
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no findings
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no findings
- 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
- 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
- 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
- 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
- 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
- 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
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