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EC number: 225-208-0 | CAS number: 4719-04-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol
- EC Number:
- 225-208-0
- EC Name:
- 2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol
- Cas Number:
- 4719-04-4
- Molecular formula:
- C9H21N3O3
- IUPAC Name:
- 2,2',2''-(1,3,5-triazinane-1,3,5-triyl)triethanol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PK 95/222
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerated
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: Young adult animals
- Housing: Single housing in fully air-conditioned rooms.
- Diet (ad libitum): Kliba-Labordiaet 341 (Klingentakmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day.
- Water (ad libitum): tap water, about 250 ml per animal per day.
- Acclimation period: for at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye.
- Amount / concentration applied:
- Each animal received a single application of 0.1 mL of undiluted test substance into the conjunctival sac of the right eye.
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 15 d and 21 d for animal 01
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Prior to treatment, both eyes of the animals were examined for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used on the study.
REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 24 hours
SCORING SYSTEM: The assessment and scoring of the findings was based on the OECD Guideline 405 (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 or 21 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 or 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-48-72- h
- Score:
- 2.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 or 21 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 or 21 d
- Irritant / corrosive response data:
- The average score (24 to 72 h) for irritation was calculated to be 0.4 for corneal opacity, 1.0 for iris, 2.1 for conjunctivae redness and 1.7 for chemosis. The findings were reversible in all animals within 15 or 21 days after application, thus the study was terminated.
The mean values were calculated according to 93/21/EEC criteria (Apr. 27, 1993).
Please refer to "Any other information on results incl. tables" for individual scores.
Any other information on results incl. tables
The following table summarizes the individual observations
Animal |
Readings (hours) |
Cornea |
Iris |
Conjunctivae |
Symptoms |
|
Redness |
Chemosis |
|||||
01 |
24 |
1 |
1 |
2 |
3 |
S, PC, DB, LC |
48 |
1 |
1 |
2 |
3 |
SR, S, PC DB, LC |
|
72 |
1 |
1 |
2 |
2 |
SR, S, PC DB, LC |
|
Mean score |
1.0 |
1.0 |
2.0 |
2.7 |
|
|
02 |
24 |
0 |
1 |
2 |
2 |
|
48 |
0 |
1 |
2 |
2 |
PC, DB |
|
72 |
0 |
1 |
2 |
1 |
PC, DB |
|
Mean score |
0.0 |
1.0 |
2.0 |
1.7 |
|
|
03 |
24 |
1 |
1 |
2 |
2 |
|
48 |
1 |
1 |
2 |
2 |
PC, DB |
|
72 |
1 |
1 |
3 |
2 |
PC, DB |
|
Mean score |
1.0 |
1.0 |
2.3 |
2.0 |
|
|
04 |
24 |
0 |
1 |
2 |
1 |
|
48 |
0 |
1 |
2 |
1 |
PC, DB |
|
72 |
0 |
1 |
2 |
1 |
DB |
|
Mean score |
0.0 |
1.0 |
2.0 |
1.0 |
|
|
05 |
24 |
0 |
1 |
2 |
1 |
|
48 |
0 |
1 |
2 |
1 |
PC |
|
72 |
0 |
1 |
2 |
1 |
PC |
|
Mean score |
0.0 |
1.0 |
2.0 |
1.0 |
|
|
06 |
24 |
0 |
1 |
2 |
2 |
|
48 |
1 |
1 |
2 |
2 |
PC, DB |
|
72 |
1 |
1 |
2 |
2 |
PC |
|
Mean score |
0.7 |
1.0 |
2.0 |
2.0 |
|
|
SR: Small retraction in the eyelids
S: Suppuration
PC: Pupil contracted
DB: Dischrage of blood
LC: Loss of corneal tissue
Slight iritis observed in all rabbits was reversible within 8 days. No eye lesions remained in any animal at the end of the 3-week observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
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