Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: human data
Adequacy of study:
supporting study
Study period:
2009-03-23 to 2009-05-01
Reliability:
other: not rated acc. to Klimisch
Rationale for reliability incl. deficiencies:
other: Relevant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
To determine by repetitive epidermal contact the potential of a test material to induce primary or cumulative irritation and/or allergic contact sensitisation.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- CAS name: Cyclohexanol, 4-(1,1-dimethylethyl)-, trans-
- Molecular formula: C10H20O
- Molecular weight: 156.3 g/mol
- Physical state: solid

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 115 qualified subjects of which 106 subjects completed this study. The remaining subjects (4 females; 4 males) discontinued their participation for various reasons, none of which were related to the application of the test material.
- Sex: males: 32; females: 83
- Age: Ranging in age from 18 to 70 years.
- Inclusion criteria:
a. Male and female subjects, age 16 (with parental or guardian consent) and over.
b. Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c. Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
d. Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e. Considered reliable and capable of following directions.
-Exclusion criteria:
a. Ill health.
b. Under a doctor's care or taking medication(s) which could influence the outcome of the study.
c. Females who are pregnant or nursing.
d. A history of adverse reactions to cosmetics or other personal care products.
Clinical history:
No data
Controls:
No data
Route of administration:
dermal
Details on study design:
10% of the test substance in neutral oil was used for application.

The upper back between the scapulae served as the treatment area. Approximately 0.2 g of the test material or an amount sufficient to cover the contact surface, was applied to the 3/4" x 3/4" absorbent pad portion of an adhesive dressing and allowed to volatilize for several minutes. This was then applied to the appropriate treatment site to form an occlusive patch.

Induction phase:
Patches were applied three times per week (e.g., monday, wednesday, and friday) for a total of nine applications. The site was marked to ensure the continuity of patch application. Following supervised removal and scoring of the first induction patch, participants were instructed to remove all subsequent Induction patches at home, twenty-four hours after application. The evaluation of this 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.

With the exception of the first supervised Induction patch reading, if any test site exhibited a moderate (2-level) reaction during the induction phase, application was moved to an adjacent area. Applications were discontinued for the remainder of this test phase, if a moderate (2-level) reaction was observed on this new test site. Applications would also be discontinued if marked (3- level) or severe (4-level) reactivity was noted.

Rest periods consisted of twenty-four hours following each tuesday and thursday removal, and forty-eight hours following each saturday removal.

Challenge phase:
Approximately two weeks after the final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site, following the same procedure described for induction. The patch was removed and the site scored at the clinic twenty-four and seventy-two hours post-application.

EVALUATIONCRITERIA (Erythema and additional Dermal Sequelae):
0 = No visible skin reaction
0.5/+ = Barely perceptible
1 = Mild
2 = Moderate
3 = Marked
4 = Severe
E = Oedema
D = Dryness
S = Staining
P = Papules
V = Vesicles
B = Bullae
U = Ulceration
Sp = Spreading

Erythema was scored numerically according to this key. if present, additional Dermal Sequelae were indicated by the appropriate letter code and a numerical value for severity.

Results and discussion

Results of examinations:
With one exception, observations remained within normal limits throughout the test interval.

It was noted that one female subject exhibited mild (1) to moderate (2) erythema and oedema response within the second induction exposure, resulting in the discontinuation of subsequent patch applications at the sixth induction exposure and again seventy-two and ninety-six hours post- challenge application.

Any other information on results incl. tables

Please also refer to "Attached background material" below for raw data.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test material, SymSitive® 1609 pur (10% in neutral oil), did not indicate a clinically significant potential for dermal irritation or allergic contact sensitisation. One subject did exhibit a pattern of skin reactivity indicative of a pre-existing hypersensitivity to one or more ingredients in this formulation. There was no evidence of induced allergic contact sensitisation.