Trihexyl benzene-1,2,4-tricarboxylate

Sensitisation data (human)

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Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

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:

publication

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Type of sensitisation studied:

skin

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD 406 (Skin sensitisation)

Principles of method if other than guideline:

Draize test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Specific details on test material used for the study:

Source and lot/batch No.of test material: Eastman Chemical Company, Kingsport, TN, USA

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 241
- Sex: 44 male, 197 female
- Age: 18-81
- Race: 75.1% Caucasian, 22.0% African-American, 2.0% Hispanic, 0.8% other races
- Demographic information: Healthy, heterogeneous adults
- Other: 38 individuals failed to complete the study

Clinical history:

- History of allergy or casuistics for study subject or populations:
- Symptoms, onset and progress of the disease: Excluded
- Exposure history: Excluded
- Aggravating factors both in home and workplace: Excluded
- Family history: Excluded
- Medical history (for respiratory hypersensitivity): Excluded
- Any other allergic or airway disorders: Excluded
- Smoking history: N/A
- Other:

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: non-woven cotton Webril (R) pad held to the skin on all sides by a strip of permeable hypoallergenic tape
- Vehicle / solvent: acetone
- Concentrations: 1% v/v
- Volume applied: Not indicated
- Testing/scoring schedule: Concurrent with inductions, and 48/96 hours after challenge application
- Removal of test substance: 24 hours after each application
- Other: 9 total inductions over a 3 week period

EXAMINATIONS
- Grading/Scoring system: 0 = No visible reaction
+ = Slight confluent or patchy erythema
1 = Mild erythema (pink)
2 = Moderate erythema (definite redness)
3 = Strong erythema (very intense redness)
- Statistical analysis: Results not statistically analyzed
- Other: Edema and papules were noted separately. Observations at the naive site during challenge and the patterns of reactivity during the induction period provided the basis for an interpretation of contact sensitisation.

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: Slight, confluent or patchy erythema (+) was maximum observed reaction during induction and challenge

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 4
- Number of subjects with negative reactions: 197
- Number of subjects with equivocal reactions: 2
- Number of subjects with irritating reactions: 4

RESULT OF CASE REPORT: Low potential for sensitisation in humans

OTHER RESULTS:

Applicant's summary and conclusion

Conclusions:

The test substance was evaluated for skin sensitisation potential according to a modified Draize patch test in human subjects. The test substance caused mild sensitisation (slight, confluent, or patchy erythema) in 4 subjects and did not cause sensitisation in 197 subjects. The test subject is considered unlikely to cause skin sensitisation in humans.