1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

16 Sep - 25 Oct 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report which meets basic scientific principles.

Data source

Reference

Reference Type:

other: report on study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

The study was conducted under GCP conditions according to the method of Marzulli and Maibach.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Triisodecyl benzene-1,2,4-tricarboxylate

EC Number:

253-138-0

EC Name:

Triisodecyl benzene-1,2,4-tricarboxylate

Cas Number:

36631-30-8

Molecular formula:

C39H66O6

IUPAC Name:

tris(8-methylnonyl) benzene-1,2,4-tricarboxylate

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 55, however only 51 subjects were available at study termination.
- Sex: 13 male, 42 female
- Age: 18-70 years

Clinical history:

None of the subjects had a history of acute or chronic dermatologic medical or physical conditions that could interfere with dermal scoring.

Controls:

no data

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: other immunological tests: Marzulli and Maibach Method

ADMINISTRATION
- Type of application: For induction, occlusive exposure for 48 hours, three times a week for three weeks on the back was performed. After a two week recovery period, a challenge exposure was performed under an occlusive dressing for 48 h either on the same site as the induction or another site that had never had contact with the test substance. The test sites were re-evaluated at 72 and 96 hours.
- Description of patch: occlusive strip with Flexcon (TruMed Technologies Inc., Burnsville, Minnesota)
- Vehicle / solvent: no
- Concentrations: undiluted test substance


EXAMINATIONS
- Grading/Scoring system: see Table 1

- Other: After each induction exposure, cutaneous reactions were evaluated directly as well as 24 and 48 h after patch removal.

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: No significant reaction attributable to sensitisation was observed in the 51 volunteers finishing the study.


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 51 (not all subjects finished study up to challenge)
- Number of subjects with irritating reactions: 1/53 (not all subjects continued study up to induction)

Any other information on results incl. tables

Table 2: Subjects with positive reactions at the study stages

Study stage	Subjects with positive reactions/all subjects*
Induction day 1	1/53**
Induction day 2	1/53**
Induction day 3	0/52
Induction day 4	0/51
Induction day 5	0/51
Induction day 6	0/51
Induction day 7	0/51
Induction day 8	0/51
Induction day 9	1/50***
48h after challenge	0/51
72h after challenge	0/50
96h after challenge	0/48

* The number of subjects changed during the study because of subjects that didn't continue the study or subjects that were not present at single observation days.

**One subject showed minimal or doubtful response, slightly different from surrounding normal skin

*** None of the subjects showed any sensitisation to the test material and only one showed slight irritation (+) at Day 9 of induction. The test material when applied to the human skin is not irritating and not sensitising.

Applicant's summary and conclusion

Conclusions:

In a study with human volunteers the test substance did not show a skin sensitisation potential.