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EC number: 615-086-0 | CAS number: 70225-05-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted according to sound scientific principles, similar to OECD TG 405. GLP
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Reference Type:
- publication
- Title:
- TRIS(2-ETHYLHEXYL)BENZENE-1,2,4-TRICARBOXYLATE
- Author:
- OECD SIDS
- Year:
- 2 002
- Bibliographic source:
- SIDS Initial Assessment Report for Siam 14: TRIS(2-ETHYLHEXYL)BENZENE-1,2,4-TRICARBOXYLATE
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate
- IUPAC Name:
- Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate
- 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
- Reference substance name:
- Nuoplaz 6959
- IUPAC Name:
- Nuoplaz 6959
- Details on test material:
- Source: Nouplaz TOTM(Tenneco Chemicals, Inc.)
Purity: 98.95%
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Temperature - 70 ± 2 degree F
Relative Humidity - 45% ± 5%
Light - 12 hour light/dark cycle
Diet - Wayne 15% Rabbit Ration and tap water are provided ad libitum.
Based on our current knowledge no contaminants are known to be in
this diet or water that might be expected to interfere with the
objectives of the study.
Caging - Stainless steel with elevated wire mesh flooring 1 rabbit/cage
Bedding - Techbord
Shepherd Products Company
Kalamazoo, Michigan 49005
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye was not treated
- Amount / concentration applied:
- 0.1 mL test material, 100% w/w%
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- 0.1 mL of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to severe as controls. The treated eyes were examined at one, two, three, four and seven days following instillation of the test materials into the eyes.
Evaluation : Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions.
Note: Under the DSD, CLP, and GHS, classification is based on the time points 24, 48, 72 hours AFTER the test material exposure has ended. In this experiment, the observation time points that correlate to these time points are 48 h (Day 2), 72 h (Day 3), and 96 h (Day 4).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: conjunctivae + chemosis score combined
- Basis:
- mean
- Time point:
- other: 48, 72, 96 h average
- Score:
- 0.57
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Time points used for classification according to DSD, CLP, and GHS
- Irritation parameter:
- other: conjunctivae + chemosis score combined
- Basis:
- mean
- Time point:
- other: 24 hours after installation (Day 1)
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- by day 3
- Irritation parameter:
- other: conjunctivae + chemosis score combined
- Basis:
- mean
- Time point:
- other: 48 hours after installation (Day 2)
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- by day 3
- Irritation parameter:
- other: conjunctivae + chemosis score combined
- Basis:
- mean
- Time point:
- other: 72 hours after installation (Day 3)
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctivae + chemosis score combined
- Basis:
- mean
- Time point:
- other: 96 hours after installation (Day 4)
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctivae + chemosis score combined
- Basis:
- mean
- Time point:
- other: Day 7
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Day 1 through Day 7
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Day 1 through Day 7
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no effects observed
- Irritant / corrosive response data:
- see Table 1 for individual animal data
Any other information on results incl. tables
Table 1 - Individual Rabbit Scores
Tissue Score - day 1 day 2 day 3 day 4 day 7
Rabbit #1
(1) Cornea total- 0 0 0 0 0
(2) Iris total - 0 0 0 0 0
(3) Conjunctivae total - 2 2 0 0 0
Total Ocular Irritation Score - 2 2 0 0 0
Rabbit #2
(1) Cornea total 0 0 0 0 0
(2) Iris total 0 0 0 0 0
(3) Conjunctivae total 4 2 0 0 0
Total Ocular Irritation Score 4 2 0 0 0
Rabbit #3
(1) Cornea total 0 0 0 0 0
(2) Iris total 0 0 0 0 0
(3) Conjunctivae total 2 2 0 0 0
Total Ocular Irritation Score 2 2 0 0 0
Rabbit #4
(1) Cornea total 0 0 0 0 0
(2) Iris total 0 0 0 0 0
(3) Conjunctivae total 2 2 0 0 0
Total Ocular Irritation Score 2 2 0 0 0
Rabbit #5
(1) Cornea total 0 0 0 0 0
(2) Iris total 0 0 0 0 0
(3) Conjunctivae total 2 2 0 0 0
Total Ocular Irritation Score 2 2 0 0 0
Rabbit #6
(1) Cornea total 0 0 0 0 0
(2) Iris total 0 0 0 0 0
(3) Conjunctivae total 2 0 0 0 0
Total Ocular Irritation Score 2 0 0 0 0
Average Ocular Irritation Score
Day 1 - 2.3
Day 2 - 1.7
Day 3 - 0.0
Day 4 - 0.0
Day 7 - 0.0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema and edema score used for classification was calculated to be 0.57. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
0.1 mL of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to severe as controls. The treated eyes were examined at one, two, three, four and seven days following instillation of the test materials into the eyes.
The average erythema and edema score used for classification was calculated to be 0.57. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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