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EC number: 302-446-4 | CAS number: 94109-09-8
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD TG 405 Draize method
- Principles of method if other than guideline:
- - Principle of test:
Draize method on rabbits
- Short description of test conditions: 2 New Zealand white rabbits each received a single dermal application of 0.5 mL of the test tem on 2 test sites, one abraded and one intact. the ttest sites were occluded for 24 hours and were observed for erythema, edema and other effects 24 and 72 h after applications.
- Parameters analysed / observed: erythema and edema - 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-134L4
- Purity test date: 10% in corn oil
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
OTHER SPECIFICS:
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: suitable licensed dealer
- Age at study initiation: 3 months
- Weight at study initiation: 2 kg
- Housing:in galvanized or stainless stell cages
- Diet (e.g. ad libitum): ration from a commercial producer
- Water (e.g. ad libitum):ad libitum
- Acclimation period:4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled room temperature
- Humidity (%): unknown
- Air changes (per hr): unknown
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- other: corn oil
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0;5 mL
- Concentration (if solution): 10% in corn oil
VEHICLE
- Amount(s) applied (volume or weight with unit): corn oil
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution): - Duration of treatment / exposure:
- 24h
- Observation period:
- 24h and 72h
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2
- % coverage: 100%
- Type of wrap if used: surgical gauze pad and a webril pad
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: 24h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24 and 72h
SCORING SYSTEM:
- Method of calculation:Draize scoring and Primary Index Irritation calculated
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tridecyl Trimellilate is not primary dermal irritant to rabbit skin and does not need to be classified for skin irritation.
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