Dodecyl laurate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Induction: Patches were applied three times a week on the back of human volunteers for a total of nine applications.
Challenge: Approximately after two weeks of rest period after the final induction patch removal a challenge patch was applied for 24 hours. The site was scored 24 and 72 hours after application.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octyl octanoate

EC Number:

218-980-5

EC Name:

Octyl octanoate

Cas Number:

2306-88-9

Molecular formula:

C16H32O2

IUPAC Name:

octyl octanoate

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 111
- Sex: male (28) and female (83)
- Age: 18 - 79 years

Clinical history:

- Other:
INCLUSION CRITERIA:
a. male and female subjects, age 16 and above
b. Absence of any visible 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 controls

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: 3/4'' x 3/4'' absorbent pad portion of an adhesive dressing
- Vehicle / solvent: corn oil
- Concentrations: 12.5 %
- Volume applied: 0.2 mL or an amount sufficient to cover contact surface
- Testing/scoring schedule: Induction exposure 3 times per week (Monday, Wednesday, Friday) for a total of nine applications, scoring was done shortly before application of a new patch, 24 hours after removal (Monday and Wednesday application) and 48 hours (Friday application); challenge exposure was done 2 weeks after removal of the last induction patch, challenge exposure lasted 24 hours. The patch was removed and the site scored at the clinic twenty-four and seventy-two hours post-application.
- Removal of test substance: no

EXAMINATIONS
- Grading/Scoring system:
0 = No visible skin reaction
0.5/+ = Barely perceptible
1 = Mild
2 = Moderate
3 = Marked
4 = Severe

E = Edema
D = Dryness
S = Staining
P = Papules
V = Vesicles
B = Bullae
U = Ulceration
Sp = Spreading

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms observed

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with negative reactions: 105

OTHER RESULTS:
- 105 of the 111 volunteers concluded 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 this study the test material at 12.5% dilution in corn oil did not indicate a potential for dermal irritation or allergic contact sensitization.