2-isopropyl-5-methyl-cyclohexanone

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: published study with few data on dermal absorption

Data source

Reference

Reference Type:

publication

Title:

In vitro evaluation of the permeation through reconstructed human epidermis of essentials oils from cosmetic formulations

Author:

Gabbanini S, Lucchi E, Carli M, Berlini E, Minghetti A, Valgimigli L

Year:

2009

Bibliographic source:

PMID:19535210 J Pharm Biomed Anal 50(3):370-6

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Experimental study validation design

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

l-Menthone

IUPAC Name:

l-Menthone

Details on test material:

- Name of test material (as cited in study report): (-)-menthone

Radiolabelling:

no

Administration / exposure

Details on study design:

Essential oil mixture employed for the analytical validation was used (5%. w/w) to prepare the massage oil, which represented the donor medium in our investigation. A diffusion cell designed for this work, whose geometry was optimized to accommodate SkinEthic(R) RHE 4.0 cm2 disks. The receptor medium composition was chosen to mimic physiological extracellular fluids; polysorbate-20 (3%, w/w) and isopropanol (0.25%, w/w) were added to increase the solubility of apolar analytes, in line with other in vitro studies and with OECD recommendations. The concentration of such solubilizers was however kept as low as possible to avoid toxicity in RHE. At the temperature of 34 ± 1 °C the donor compartment was loaded with 1.0 mL oil of oleolite so to operate under "infinite dose" conditions and avoid significant decrease of analytes' concentration in the donor during the diffusion experiment. The percutaneous absorption profile was determined by HS/SPME-GC-MS analysis of the receptor medium, sampling from each diffusion cell at regular intervals. Under the steady-state approximation, which is valid when the concentration gradient through the skin membrane is constant, the diffusion process occurs in accordance with Fick's first law.

Results and discussion

Any other information on results incl. tables

Percutaneous penetration permeability coeficient (Ps) of Menthone from applied essential oil mixture through SkinEthic(R) reconstructed human epidermis (RHE) was 0.40±0.01 x10^-3 cm/h.

Applicant's summary and conclusion

Conclusions:

Investigated menthone in essential oil mixture was found to cross SkinEthic(R) RHE with a permeability coeficient Ps=0.4±0.01 x 10^-3 cm/h.

Executive summary:

The diffusion kinetic for Menthone chosen as analytical marker of a mixture of plant essential oils contained in cosmetic formulation was probed by HS/SPME-GC-MS analysis and elaborated according to Fick's first law to obtain the skin permeability coeficient (Ps=0.40 x10^-3 cm/h).