Pentadecan-15-olide

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

30 October – 7 December 2006

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Repetitive insult patch test: 114 human volunteers were topically induced with 9 occluded patches of the test material over a period of 3 weeks followed by a challenge patch after a rest period of 2 weeks and then the application sites were scored for skin irritation.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pentadecan-15-olide

EC Number:

203-354-6

EC Name:

Pentadecan-15-olide

Cas Number:

106-02-5

Molecular formula:

C15H28O2

IUPAC Name:

1-oxacyclohexadecan-2-one

Test material form:

not specified

Details on test material:

None

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 114
- Number of subjects completed the study: 105; nine subjects discontinued their participation for various reasons, none of which were related to the application of the test material
- Sex: Male and female
- Age: 17-78 years

Clinical history:

- Inclusion criteria:
a. Male and female subjects, age 16 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.

Controls:

No

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: Patch test (epicutaneous test)

ADMINISTRATION
- Type of application: Occlusive
- Site: Upper back between the scapulae
- Vehicle: Diethylphthalate/Ethanol: 3:1 (v/v)
- Concentrations: 10 % in vehicle
- Volume applied: 0.2 mL
- Description of patch: Approximately 0.2 mL 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. This was then applied to the appropriate treatment site to form an occlusive patch.
- Testing/scoring schedule:
Induction phase: Patches were applied three (3) times per week (e.g., Monday, Wednesday, and Friday) for a total of nine (9) applications. After 24 or 48 h of each application, patches were removed and evaluated for irritation scores.
Challenge phase: Approximately two (2) 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 24 and 72 h post-application.

EXAMINATIONS
- Grading/Scoring system:
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
4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration

Results and discussion

Results of examinations:

RESULT OF CASE REPORT: Observations remained within normal limits throughout the test interval.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Under the test conditions, the test material (10 % in diethylphthalate/ethanol: 3:1 v/v), was not considered as a skin sensitiser or irritant in human volunteers.

Executive summary:

In a repetitive insult patch test, 114 adult male and female human volunteers were topically induced with 9 occluded patches (3 times/week) of 0.2 mL of the test material (10 % in diethylphthalate/ethanol: 3:1 v/v) over a period of 3 weeks, applied on the upper back between the scapulae of each individual. After 24 or 48 h of each application, patches were removed and evaluated for irritation scores. After 2 weeks, 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 was scored at 24 and 72 h post-application.

 

Observed skin irritation scores remained within normal limits throughout the test interval.

 

Under the test conditions, the test material (10 % in diethylphthalate/ethanol: 3:1 v/v), was not considered as a skin sensitiser or irritant in human volunteers.