Methyl 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:

01 Aug - 08 Aug 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Reference 2

Reference Type:

secondary source

Title:

Use of HumanData in Hazard Classification for Irritation and Sensitization

Author:

Ecetoc

Year:

2002

Bibliographic source:

Ecetoc Monograph No. 32; ISSN-0773-6347-32

Materials and methods

Type of study / information:

Assessment of skin tolerance towards various raw materials of cosmetic products in a closed patch epicutaneous test, comparable to actual COLIPA standards.

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: COLIPA - Guidelines for the Assessment of Skin Tolerance of Potential Irritant Cosmetic Ingredients

Deviations:

yes

Remarks:

limited information on test substance

Principles of method if other than guideline:

70 µL of the test substances are applied once on the back of volunteers for 24 h with occlusive patches (Large Finn Chamber on Scanpor). The skin is subsequently examinated at 1, 6, 24, 48, 72 and 144 h after the end of the exposure period, and effects are graded according to the method of Frosch. Test was performed before actual guideline was established.

GLP compliance:

no

Remarks:

(GCP compliant)

Test material

Test material information

Constituent 1

Reference substance name:

Methyl palmitate

EC Number:

203-966-3

EC Name:

Methyl palmitate

Cas Number:

112-39-0

Molecular formula:

C17H34O2

IUPAC Name:

methyl palmitate

Details on test material:

- Name of test material (as cited in study report): fatty acid methyl ester C: Palm - FSME013
- Substance type: fatty acid methyl ester
- Physical state: liquid
- Analytical purity: not reported

Method

Ethical approval:

confirmed and informed consent free of coercion received

Details on study design:

The test substance was tested by occlusive epicutaneous application according to the method of Frosch (Finn Chamber Assay, modified Duhring-Chamber-Test). A volume of 70 µL of the test substance was once applied to the back skin of each volunteer for 24 hours by means of a Large Finn Chamber on Scanpor (supplied by Hermal). The resulting reactions were scored for erythema, edema, desquamation and fissures at 1, 6, 24, 48, 72 and 144 hours after removal of the patch. A 1% dilution of Texapon N25, distilled water, physiological NaCl and paraffin oil served as reference standards.
The study was performed using 20 healthy volunteers of both genders with an age between 21 and 50 years (average age 32 years).

Exposure assessment:

measured

Details on exposure:

TYPE OF EXPOSURE: on the back of 20 volunteers under occlusive patches (Large Finn Chambers on Scanpor; modified Duhring-Chamber-Test

TYPE OF EXPOSURE MEASUREMENT: application of a well-defined amount of test-substance of known concentration

EXPOSURE LEVELS: 70 µL of 50 % test substance concentration

EXPOSURE PERIOD: 24 hours

POSTEXPOSURE PERIOD: 1, 6, 24, 48, 72 and 144 hours

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: all subjects treated in identical manner

SCORING CRITERIA
Erythema:
0 Negative
1 very slight, punctual or diffuse erythema
2 well perceptible and well defined erythema (12 mm diameter)
3 moderate erythema
4 severe crimson erythema with edema or epidermal defect (small blisters, necrosis)

Edema:
0 negative
1 very slight, barely perceptible
2 slight swelling (edges of area well defined by definite raising, swelling <1 mm)
3 marked swelling (raised approx. 1 mm)
4 severe swelling (>1 mm and extending beyond area of exposure)

Desquamation:
0 negative
1 dryness of skin, shiny appearance of the skin
2 slight scaling
3 moderate scaling
4 severe scaling

Fissures:
0 negative
1 very superficial epidermal separation
2 scattered or several extended fissures
3 deep fissures with hemorrhages and exsudation

Results and discussion

Results:

The test substance induced slight erythema only in individual cases. The reactions were well below the irritation potential of the internal positive standard of 1% Texapon N25.
Calculation of the irritation scores for erythema and erythema, edema, desquamation and fissuring in relation to 1% Texapon N25 (representing 100%) revealed the following values for the test item: 2.13% for erythema and 1.89% for erythema, edema, scale and fissuring, together.
Thus, the test substance is well-tolerated by human skin and does not need to be classified as irritating to human skin.

Any other information on results incl. tables

Calculation of irritation scores (%) in relation to the positive control Texapon N25 (representing 100%):

	Erythema	Erythema, edema, desquamation, fissures
Texapon N25	100.00	100.00
Test substance	2.13	1.89
Paraffin oil	0.00	0.00
Distilled water	1.06	0.94
Phys. NaCl	5.32	4.72