Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 Dec 1996 - 10 Jan 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human Repeat Insult Patch Test with 93 volunteers
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Docosanoic acid, ester with 1,2,3-propanetriol
EC Number:
278-717-5
EC Name:
Docosanoic acid, ester with 1,2,3-propanetriol
Cas Number:
77538-19-3
Molecular formula:
C25H50O4
IUPAC Name:
Docosanoic acid, ester with 1,2,3-propanetriol
Details on test material:
- Name of test material (as cited in study report): Behenate de Glycerol
- Physical state: off-white pellets
- Analytical purity: no data

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Remarks:
Legally valid written consent, in conformity with: 21 CFR Part 50: "Protection of Human Subjects" was secured from each subject.
Subjects:
- Number of subjects exposed: 107 empaneled, 93 completed
- Sex: male and female
- Age: 18-58 years (males), 18-67 years (females)
- Other: No subject was used if he/she exhibited or had a history of any dermatological or other medical or physical condition which could preclude topical application of the test material. No known pregnant or nursing women were used on this study.
A period of at least 6 weeks had elapsed since a subject was patched in a Repeated Insult Patch Test (RIPT) or Photoallergy Test (PA) before he/she was used on this RIPT study.
Controls:
None
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: a webril/adhesive patch (Professional Medical Products #4022) was used.
- Vehicle / solvent: unchanged
- Amount applied: approx. 0.2 g (previously molten at 70-80 °C)
- Application site: the left scapular area was the test area for the induction phase. The subject's skin was marked with a gentian violet surgical skin marker at the left side of the test site. The test site was recorded on the anatomical diagram on the back of each subject's individual data form.
- Testing/scoring schedule:
-- Induction: a series of nine (9) induction patchings were completed over a period of three weeks on Mondays, Wednesdays and Fridays.
If a subject was unable to make up a missed patching during the same week, the subject was patched four days the following week (Monday, Tuesday, Thursday and Friday) or was repatched at the end of the induction phase (tenth test day). Any absences and repatchings were noted. Additional absences necessitated dropping the subject from the panel.
Each subject was instructed that the patch was to remain in place and kept dry for approx. 24 h, at which time the patch was to be removed by the subject. A 24 h period, during which no test material was applied, followed the removal of the Monday and Wednesday patch applications; a 48 h period followed the Friday patch applications.
Each subject returned to the testing laboratory on the appropriate day. The test site was observed by the testing laboratory's project manager, and the reaction scored and recorded.
The identical test site was then repatched until the nine induction patchings were completed.
-- Rest period: a rest period of approx. two weeks followed the last induction patching; no test material was applied during the rest period.
-- Challenge Phase: at the challenge phase, the original induction test site was observed and each subject queried as to whether any reaction was experienced during the rest period. The right scapular area was the virgin test site for the challenge phase. The challenge test site was recorded on the anatomical diagram on the back of each subject's individual data form.
The challenge patch was applied to the virgin site only. Each subject was again instructed to keep the patch on and dry.
Each subject reported to the testing laboratory approx. 24 h later, at which time the patch was removed and the challenge site scored by the testing laboratory's project manager. The original test site was also observed.
Each subject reported to the testing laboratory at approx. 48, 72 and 96 h post-patching for additional observations; reactions were scored and recorded.

EXAMINATIONS
- Grading/Scoring system: modified scoring scale of the International Contact Dermatitis Research Group System: Fisher, Alexander A., Contact Dermatitis, Lea & Febiger, Philadelphia, 1986: p. 26 (see Table 1 for details).

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 93 (26 males, 67 females)
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

Induction Phase

Three female subjects received 9 induction patchings but were unable to return to the testing facility for the final induction reading; they were therefore given a reading of N9R (No Ninth Reading).

Challenge Phase

A female subject was repatched at 24 h because her challenge patches had fallen off during the evening. The same subject missed the 96 h challenge visit; she returned to the testing facility at 144 h and her site was negative. A verbal report from the subject stated "no reaction at 96 h".

Applicant's summary and conclusion

Conclusions:
Not sensitising.