Registration Dossier
Registration Dossier
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EC number: 302-446-4 | CAS number: 94109-09-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 22, 2006 to April 6, 2006
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- the objective of this study was to determine the irritation and/or sensitization potential of the test article after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel).
- GLP compliance:
- yes
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
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- a Total of 57 subjects, 9 males and 48 females ranging in age from 18 to 76 years, were empaneled for this test.
- Route of administration:
- dermal
- Details on study design:
- 0.2 mL of teh test material was placed onto an occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.
Thi procedure was performed by a trained technician/examiner and repeated every Monday, Wednesday and Friday until 9 applications of the test article had been made.
The subjects were instructed to remove the patch 24 hours after application. 24 hour rest periods followed the Tuesday and Thursday removal and 48-hour rest periods followed each Saturday removal. Subjects returned to the Testing Facility and the site was scored by a trained examiner just prior to the next patch application.
Results and discussion
- Results of examinations:
- 51/57 subjects satisfactorily completed the test procedure.
5 subjects discontinued for personal reasons unrelated to teh conduct of the study.
1 test panelist was discontinued due to violation of the protocol; the subject was taking concomitant medications.
There was no skin reactivity observed at any time during the course of the study.
Applicant's summary and conclusion
- Conclusions:
- Tridecyl Trimellilate did not induce skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.
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