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EC number: 222-020-0 | CAS number: 3319-31-1
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:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Federal Substances Act as described in the Federal Register, Section 1500.41 Federal Hazardous Substances Act Regulations - 16 CFR P 125
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- EC Number:
- 222-020-0
- EC Name:
- Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- Cas Number:
- 3319-31-1
- Molecular formula:
- C33H54O6
- IUPAC Name:
- tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- Details on test material:
- - Name of test material (as cited in study report): Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye remained untreated & acted as a control
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 7d
- Observation period (in vivo):
- 7d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure:N/A
SCORING SYSTEM: Draize (see table below)
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: No data
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:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- Not reported
Any other information on results incl. tables
Animal number |
Time |
Cornea |
Iris inflammation |
Conjunctivae |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
1 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
3 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
4 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
5 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tris (2-ethylhexyl)trimellitate (TOTM) is not a primary ocular irritant within the definition of the Act Referenced 1500.42 (b) (1) (2).
- Executive summary:
Acute eye irritation has been assessed in the rabbit using FHSA methods.
The severity and persistence of ocular response was not sufficient for the substance to require classification as an eye irritant
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
