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Toxicological information

Skin irritation / corrosion

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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:
1986
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

Constituent 1
Chemical structure
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%
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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