Decanoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Skin Corrosivity Potential of Fatty Acids: In vitro Rat and Human Skin Testing and QSAR Studies

Author:

Whittle, E. et al.

Year:

1996

Bibliographic source:

Toxicology in Vitro 10: 95 - 100

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Human skin tissue samples were exposed to the test item for 24 h. Afterwards, in vitro skin corrosivity potential was evaluated via transcutaneous electrical resistance (TER) measurements.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid

EC Number:

206-376-4

EC Name:

Decanoic acid

Cas Number:

334-48-5

Molecular formula:

C10H20O2

IUPAC Name:

decanoic acid

Test animals

Species:

human

Strain:

other: human mammary full-thickness tissue without subcutaneous tissue

Test system

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Controls:

other: concurrent control tissues treated with distilled water (negative control)

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 150 µL
- Concentration: 100%

Duration of treatment / exposure:

24 h

Observation period:

Not applicable.

Number of animals:

Not applicable.
Skin samples were obtained from 1 donor.
The test was performed in at least triplicates.

Details on study design:

SKIN PREPARATION
Waste full-thickness human mammary tissue was obtained after cosmetic surgery. The tissue was stored at -70 °C and thawed when required by placing in a refrigerator for 24 h. Subcutaneous tissue was carefully removed, ensuring that no damage occured to the dermis. Tissue with epidermis uppermost was attached to polytetrafluorethylene tubes using a rubber "O" ring and sealed with soft paraffin wax. As supporting electrolyte, magnesium sulfate solution (154 mM MgSO4 in distilled water) was used. 150 µL of the test substance was added to the epidermis of each skin disc for 24 h.

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was washed away with a controlled jet of water.

TRANSCUTANEOUS ELECTRICAL RESISTANCE MEASUREMENTS: After washing, tissues were treated briefly with 20 µL 70% ethanol. Subsequently, 3 mL electrolyte solution was added to the tissue surface before resistance measurements occured using an AIM 6401 Databridge (H. Tinsley, Croydon, England). Corrosivity to human skin was considered when the TER is reduced to below 11.0 kΩ.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

transcutaneous electrical resistance (in kΩ)

Remarks:

mean of at least 3 skin discs

Run / experiment:

24 h

Value:

29.9

Remarks on result:

other: tissue stored frozen before use; standard deviation: ± 5.4 kΩ/disc

Other effects / acceptance of results:

No decrease below 11 kΩ in the transcutaneous electrical resistance was observed in the human tissue preparation after 24 h exposure to decanoic acid. Thus decanoic acid is considered to be non-corrosive.

Applicant's summary and conclusion

Interpretation of results:

other: non-corrosive

Conclusions:

Decanoic acid showed no corrosive potential in the in vitro transcutaneous electrical resistance test in human tissue samples.