Registration Dossier
Registration Dossier
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EC number: 302-446-4 | CAS number: 94109-09-8
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tri(tridecyl) benzene-1,2,4-tricarboxylate
- EC Number:
- 302-446-4
- EC Name:
- Tri(tridecyl) benzene-1,2,4-tricarboxylate
- Cas Number:
- 94109-09-8
- Molecular formula:
- C48H84O6
- IUPAC Name:
- tri(tridecyl) benzene-1,2,4-tricarboxylate
- Test material form:
- liquid
- Details on test material:
- - Moisture content: <= 0.1%
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot P-712E4
- Expiration date of the lot/batch: unknown
- Purity test date: > 99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: stable in corn oil
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Final dilution of a dissolved solid, stock liquid or gel: 10% in corn oil
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: unknown
- Age at study initiation: unknown
- Weight at study initiation: unknown
- Housing: unknown
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum): ad libitum
- Acclimation period: unknown
Test system
- Vehicle:
- other: corn oil
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10% in corn oil
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: 24h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- ca. 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7 d
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tridecyl Trimellilate is slightly irritating to rabbit conjonctivae, and does not need to be classified for eye irritation.
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