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EC number: 212-660-9 | CAS number: 839-90-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: according to information in OECD SIDS (2002)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ; 50 mg instead of 100 mg test substance instilled
- GLP compliance:
- no
Test material
- Reference substance name:
- Tris(2-hydroxyethyl)-1,3,5-triazinetrione
- EC Number:
- 212-660-9
- EC Name:
- Tris(2-hydroxyethyl)-1,3,5-triazinetrione
- Cas Number:
- 839-90-7
- Molecular formula:
- C9H15N3O6
- IUPAC Name:
- tris(2-hydroxyethyl)-1,3,5-triazinane-2,4,6-trione
- Details on test material:
- - Name of test material (as cited in study report): THEIC
- Physical state: solid
- Analytical purity: ca. 99%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler (breeder)
- Weight at study initiation: 2.98 and 3.09 kg
ENVIRONMENTAL CONDITIONS
not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 50 mg talcum into the other eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
50 mg into the conjunctival sac of one eye per rabbit. The contralateral eye received 50 mg talcum to serve as a control. - Duration of treatment / exposure:
- Once. There was no mentioning in the raw data or report that eyes were rinsed after treatment. Consequently the treatment/exposure period was equivalent to the entire observation period following administration, which was 8 days, or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.
- Observation period (in vivo):
- 8 days (observations at 10 min, 1 h, 3h, 1, 2, 3, 4, 7 and 8 days post instillation)
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM:
Descriptive grading in the raw data: no effect / questionable / slight / strong / very strong.
In addition, indication of the type of finding as appropriate: erythema / edema / scale formation / necrosis / opacity / scar.
The descriptive scores in the raw data were converted into OECD/ Draize scores.
FLUORESCEIN:
On day 8 staining with fluorescein to support eye evaluation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Secretion was noted in one animal at 10 min post instillation in the other animal at 1 h post instillation, but was no longer seen thereafter.
Any other information on results incl. tables
Animal |
Reading |
Opacity |
Iritis |
Redness |
Chemosis |
Comment |
1 |
1 h |
0 |
0 |
1 |
0 |
Secretion |
2 |
1 h |
0 |
0 |
1 |
0 |
|
1 |
24 h |
0 |
0 |
0 |
0 |
|
2 |
24 h |
0 |
0 |
0 |
0 |
|
1 |
48 h |
0 |
0 |
1 |
0 |
|
2 |
48 h |
0 |
0 |
1 |
0 |
|
1 |
72 h |
0 |
0 |
1 |
0 |
|
2 |
72 h |
0 |
0 |
1 |
0 |
|
1 |
4 d |
0 |
0 |
1 |
0 |
|
2 |
4 d |
0 |
0 |
1 |
0 |
|
1 |
7 d |
0 |
0 |
1 |
0 |
|
2 |
7 d |
0 |
0 |
1 |
0 |
|
1 |
8 d |
0 |
0 |
1 |
0 |
score before application of fluorescein |
2 |
8 d |
0 |
0 |
0 |
0 |
score before application of fluorescein |
1 |
8 d |
0 |
0 |
0 |
0 |
score after application of fluorescein |
2 |
8 d |
0 |
0 |
0 |
0 |
score after application of fluorescein |
mean |
24 - 72 h |
0.00 |
0.00 |
0.67 |
0.00 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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