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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-09-21 - 1981-10-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
- reduced numbers of animals used (10 rather than 20 in test group), no control animals
Principles of method if other than guideline:
A group of ten male albino guinea pigs weighing between 300 and 400 grams each was employed in this study.
A 0.5 ml portion of material was applied to the intact skin test sites on the guinea pigs. A gauze patch was placed over the treated area and an impervious material was wrapped snugly, around the trunks of the animals to hold the patch in place.
After a 24 hour contact period the patch was removed and the animals were allowed to rest for one day. Following this rest period another application was applied to the same skin site using a fresh sample. This sequence was repeated for a total of ten applications. After the tenth application the animals were rested for a two week period. At the termination of the rest period a challenge application was put on skin sites differing fro;n the original test sites. The challenge application remained on for 24 hours.
Twenty-four hours after each induction stage application and twenty-four and forty-eight hours after the challenge (re-test) application, the sites were examined for irritation, if any, using the Draize method of scoring to grade reactions.
GLP compliance:
yes
Type of study:
other: modified Buehler method
Justification for non-LLNA method:
A non-LLNA method was used because data from a modified Buehler test from 1981 is available.

Test material

Constituent 1
Chemical structure
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:
Tris(2-ethoxyhexyl)trimellitate (CAS 3319-31-1): 98.95 %
2-Ethylhexanol: 0.5 %
Miescellaneous Esters: 1.00 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
A group of ten male albino guinea pigs weighing between 300 and 400 grams each was employed in this study.

Husbandry Conditions:
Temperature: 70°F + /-2°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: Techboard Shepherd Products Company Kalamazoo, Michigan 49005

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL pure substance
Day(s)/duration:
24 h / 10 times
Adequacy of induction:
not specified
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL pure substance
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24 h
- Test groups: 1
- Control group: 0 (none)
- Frequency of applications: 10 with a 24h recovery period between them
- Duration: Until had been applied 10 times
- Concentrations: 0.5 ml of 100% neat

B. CHALLENGE EXPOSURE
- No. of exposures: 10
- Day(s) of challenge: 2 weeks after 10th sensitising/induction application
- Exposure period: 24 h
- Test groups: 1
- Control group: 0 (none)
- Concentrations: 100%, used as supplied
- Evaluation (hr after challenge): 24 and 48h
Challenge controls:
No
Positive control substance(s):
no

Results and discussion

Positive control results:
No positive control group

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
pure substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
pure substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
Reading:
other:
Group:
negative control
Remarks on result:
not measured/tested
Reading:
other:
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Table with results is shown in attached file (Skin sesitisation - guinea pig_tables.pdf) on page 2.

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS (CLP) criteria not met
Conclusions:
Under the conditions of this test is not a primary irritant, fatiguing agent or skin sensitiser in the albino guinea pig. No skin reactions were seen during the induction (sensitising) phase or subsequent challenge phase.
Executive summary:

Delayed dermal sensitisation of tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate has been assessed using an in vivo modified Buehler method similar to OECD Guideline 406 and in compliance with GLP criteria.

24 hour covered contact with 0.5 ml neat tris(2-ethylhexyl) benzene-1,2,4-tricarboxylateon the intact skin of guinea pigs was repeated on alternate days for 10 applications. After the tenth application the animals were rested for a two week period. A similar challenge application was made after a 2 week rest period. The sites were examined for irritation, if any, using the Draize method of scoring to grade reactions.

No sensitization was seen in any of the 10 animals tested. Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate did not induce sensitization.