Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
10 Jul 2000 to 26 Oct 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

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:
- Principle of test: Repeated Insult (occlusive) Patch Test
- Short description of test conditions: During the induction phase patches were applied three times per week (e.g. Monday, Wednesday and Friday) for a total of nine applications. Approximately two weeks after the final induction patch application, challenge patches were applied to the virgin test sites adjacent to the original induction patch site.
- Scoring: the sites were scored for skin reactions at the clinic 24, 48 and 72 hours post application.
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
3-(p-cumenyl)propionaldehyde
EC Number:
231-885-3
EC Name:
3-(p-cumenyl)propionaldehyde
Cas Number:
7775-00-0
Molecular formula:
C12H16O
IUPAC Name:
3-[4-(propan-2-yl)phenyl]propanal
Test material form:
liquid

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 113
- Sex: male and female
- Age: 19 to 76
- Race: Not specified
Clinical history:
- Healthy subjects were selected based on the absence of pre-existing skin disease which might be confused with a skin reaction from the the material or may be reasonable expected to affect the outcome of the study.
- Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to the study
- Subjects were excluded if under a doctors care or taking medication which could influence the outcome of the study. In addition, subjects with a history of adverse reactions to cosmetics or other personal care products were excluded. Females must be non-pregnant or nursing.
Controls:
As a negative control distilled water in vehicle was applied
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: The test material was applied to the 3/4"x 3/4" (equivalent to 3.6 cm²) gauze portion of an adhesive dressing. These patches were allowed to air dry for 30 min, not exceeding 90 min before application.
- Vehicle / solvent: alcohol SD39C:DEP (75:25)
- Concentrations: 2% (w/w)
- Volume applied: 0.2 mL of each test material
- Testing/scoring schedule:
Induction phase: Patches were applied three times per week (e.g. Monday, Wednesday and Friday) for a total of nine applications. The evaluation of each site was made again just prior to re-application. If a participant was unable to report for an assigned test day, one makeup day was permitted. This day was added to the induction period. Rest periods consisted of 24 hours following each Tuesday and Thursday removal and 48 hours following each Saturday removal.
Challenge phase: Approximately two weeks after the final induction patch applications, challenge patches were applied to virgin test sites adjacent to the original induction patch sites, following the same procedure described for induction. The patches were removed and the sites were scored at the clinic 24, 48 and 72 hours pos-application.
- Removal of test substance: Following supervised removal and scoring of the first induction patches, participants were instructed to remove all subsequent induction patches at home, 24 hours after application. During the challenge phase, patches were removed and the sites scored at the clinic 24, 48 and 72 hours post-application.
- Other: The upper back between the scapulae served as treatment area.

EXAMINATIONS
The scoring system used:
0= No visible skin reaction
+= Barely perceptible or spotty erythema
1= Mild erythema covering most of the test site
2= Moderate erythema, possible presence of mild edema
3= Marked erythema, possible edema

Results and discussion

Results of examinations:
- At an application of 2% Cyclemax both treatment sites remained negative throughout the test interval.
- 99 subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the test a test substance concentration of 2% test substance was not sensitising.
Executive summary:

A HRIPT test was performed with 2% test substance in a vehicle of alcohol SD39C:DEP (75:25). 99 volunteers finished the study and were exposed to 0.2 mL solution under occlusive conditions. The subjects were instructed to remove the bandages 24 hours after application. Application sites were evaluated again just prior to re-application. During the induction phase, the subjects were administered 3 days a week (e.g. Monday, Wednesday and Friday) till 9 applications had been made. The test patch was applied to the same site each time. As a negative control, patches with distilled water in vehicle were applied. After approximately two weeks challenge patches were applied to a virgin test site, and removed after 24 hours. Reactions to the challenge were analyzed after 24, 72 and 96 hours. None of the 99 subjects showed reactions to the test material during the study. Therefore, under the conditions of the test 2% test, substance was concluded not to be sensitizing.