Hexadecyl palmitate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

5 - 11 June 1991

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:

1991

Report date:

1991

Materials and methods

Type of study / information:

Study of the epicutaneous local irritant potential after a single application to the intact skin of the back and under occlusive patch for 24 hours in 10 healthy adult volunteers

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

GLP compliance:

no

Remarks:

, but according to Good Clinical Practice (GCP)

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyl palmitate

EC Number:

208-736-6

EC Name:

Hexadecyl palmitate

Cas Number:

540-10-3

Molecular formula:

C32H64O2

IUPAC Name:

hexadecyl hexadecanoate

Test material form:

solid

Specific details on test material used for the study:

20% w/v dilution in stone oil

Method

Ethical approval:

confirmed and informed consent free of coercion received

Details on study design:

Inclusion criteria: Caucasian origin (white skin colour), 18-70 years old, males and females, weight within the limits of the scale proposed by the Metropolitan Insurance Company, Health condition corresponding to the selection criteria defined in the medical questionnaires and examinations, volunteers able to justify a fixed abode, able to read the presented documents and to hold to what was explained, affiliated to a social security organization
Exclusion criteria: several as listed in study report
Number of volunteers: 10 (9 female, 1 male)
Age of volunteers: 19 - 41 years old
Weight: 48 to 66 kg

Exposure assessment:

measured

Details on exposure:

The test article was applied in a 20% (w/v) dilution in stone oil (for dilution pre-warmed to 75°C), once only, at the dose level of about 0.02 g per volunteer, on a surface of about 50 mm² of intact skin on the back of 10 volunteers, of both genders, healthy adults.
The test article was kept in contact with the skin under an occlusive patch (Finn Chamber on Scanpor) for 24 hours.
As negative control a patch alone (without test article) was applied in parallel and under the same conditions.
Macroscopic examination: at 1 hour after removal of patches.
Assessment: erythema (max score 4) and edema (max score 3) reactions according to a given numerical scale: 0 = no erythema/edema, 1 = very slight, 2 = clearly visible, 3 = severe, 4 = purpuric erythema

Results and discussion

Results:

Mean scores of 10 volunteers were 0.0 for erythema and 0.0 for edema.

Applicant's summary and conclusion

Conclusions:

The test substance was not irritant to healthy intact human skin of volunteers after exposure of a 20% (w/v) dilution in stone oil for 24h under occlusive conditions with skin readings performed at 1 hour after patch removal.