Registration Dossier

Administrative data

sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From January 4 to February 12, 2010

Data source

Reference Type:
study report
Report Date:

Materials and methods

Type of sensitisation studied:
Study type:
study with volunteers
Principles of method if other than guideline:
Occlusive repeated insult patch study in humans
GLP compliance:

Test material

Test material form:
Details on test material:
- Physical state: Clear colorless liquid
- Storage condition of test material: Ambient


Type of population:
Ethical approval:
confirmed and informed consent free of coercion received
- Number of subjects exposed: 101 subjects completed the study (113 were enrolled)
- Sex: 35 males and 78 females
- Age: 19-70 years
- Race: Asian (4); Black (9); Caucasian (86); Hispanic (14)
Clinical history:
Inclusion Criteria
Individuals eligible for inclusion in the study were those who:
1. were males or females, 18 years of age or older, in general good health;
2. were free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, would have interfered with the study results or increased the risk of adverse events;
3. were of any skin type or race providing the skin pigmentation would allow discernment of erythema;
4. had completed a medical screening procedure; and
5. had read, understood and signed an informed consent agreement.

Exclusion Criteria
Individuals excluded from participation in the study were those who:
1. had any visible skin disease at the study site which, in the opinion of the investigative personnel, would have interfered with the evaluation;
2. were receiving systemic or topical drugs or medication which, in the opinion of the investigative personnel, would have interfered with the study results;
3. had psoriasis and/or active atopic dermatitis/eczema;
4. were females who were pregnant, planning to become pregnant during the study, or breast-feeding; and/or
5. had a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.
Route of administration:
Details on study design:
TYPE OF TEST(S) USED: Patch test

- Type of application: Occlusive
- Description of patch: Material was evaluated under an occlusive molded plastic chamber patch (25 mm Hilltop Chamber) lined with a non-woven cotton pad. The patch was secured with hypoallergenic tape (Micropore), as needed.
- Vehicle / solvent: 75 % Diethyl Phthalate (DEP) / 25 % Ethanol
- Concentrations: 1 %
- Volume applied: 0.3 mL
- Testing/scoring schedule: Subjects participated over a 6-week period involving 3 phases: (1) Induction, (2) Rest, and (3) Challenge.
Induction phase: 9 consecutive applications, 48 h intervals (72 h weekend). Subjects who were absent once during the induction phase received a make-up (MU) patch at the last induction visit. The MU applications were graded 48 hours later at the MU visit, or were recorded as N9G (no ninth grading). Subjects who missed the ninth evaluation (N9G) but have had 9 patch applications and 8 evaluations were considered to have completed the induction phase.
Rest period: 10-15 days
Challenge phase: During the 6th week of the study
- Removal of patches: Approximately 24 h after each application
- Other: Patches were applied to the infrascapular area of the back, either to the right or left of the midline.

During induction, sites were evaluated at 48 h intervals (72 h if weekend). After challenge, evaluations were done at 72 and 96 h after application.
Grading/Scoring system:
- = No reaction
? = Minimal or doubtful response, slightly different from surrounding normal skin
+ = Definite erythema. No oedema
++ = Definite erythema. Definite oedema.
+++ = Definite erythema. Definite oedema and vesiculation.

Statistical analysis: None

Results and discussion

Results of examinations:
- Frequency, level, duration of symptoms observed: None

- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 101
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

One hundred thirteen (113) subjects between the ages of 19 and 70 were enrolled and 101 subjects completed the study. There were no adverse events reported.

Applicant's summary and conclusion

Under the condition of the study, the test material is not a skin sensitiser at 1 % in 75 % Diethyl Phthalate (DEP) / 25 % Ethanol.
Executive summary:

A panel of 113 male and female human volunteers participated in a repeat insult patch test in which a 1 % solution of test material in 75 % Diethyl Phthalate (DEP) / 25 % Ethanol applied to the back of the subjects under occlusive patches. 101 subjects completed the study. During the induction phase nine patches were applied, separated by a 48 h interval. The patches were removed 24 h after application. Following a 10-15 days rest period, a challenge patch was applied and the sites scored 72 and 96 h after application.

Under the conditions employed in this study, there was no evidence of sensitisation to the test material at 1 %.