Squalene-rich fraction obtained from vegetable oil deodorizer distillate by transesterification, crystallisation and vacuum distillation

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:

secondary literature

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

review article or handbook

Title:

Final report on the safety assessment of tocopherol, tocopheryl acetate, tocopheryl linoleate, tocopheryl linoleate/oleate, tocopheryl nicotinate, tocopheryl succinate, dioleyl tocopheryl methylsilanol, pot. ascorbyl tocopheryl phosphate, & tocophersolan

Author:

Fiume MZ

Year:

2002

Bibliographic source:

Int. J. Toxicol. 21(6):51-116

Materials and methods

Principles of method if other than guideline:

The penetration of the constituent alpha-tocopherol was determined using three human abdominal skin samples and three Skh:HR-1 mouse dorsal skin samples.

Test material

Test material information

Constituent 1

Reference substance name:

α-tocopherol

EC Number:

200-412-2

EC Name:

α-tocopherol

Cas Number:

59-02-9

Molecular formula:

C29H50O2

IUPAC Name:

2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol

Constituent 2

Reference substance name:

alpha-Tocopherol

IUPAC Name:

alpha-Tocopherol

Details on test material:

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

Radiolabelling:

no

Test animals

Species:

other: in vitro

Administration / exposure

Duration of exposure:

24 h

Doses:

5% alpha-tocopherol (0.12 M)

No. of animals per group:

In vitro; human and mice skin sample

Details on in vitro test system (if applicable):

SKIN PREPARATION
- Source of skin: Human abdominal skin and three Skh:HR-1 mouse dorsal skin samples

PRINCIPLES OF ASSAY
- Diffusion cell: Franz-type diffusion cells

Results and discussion

Signs and symptoms of toxicity:

not specified

Dermal irritation:

not specified

Absorption in different matrices:

- The average cumulative penetration through human skin for tocopherol was 14 and 227 µg/cm2 after 2 and 24 h respectively.
- Using mouse skin, the average cumulative penetration of tocopherol was 50 and 628 µg/cm2 after 2 and 24 h, respectively.

Applicant's summary and conclusion

Conclusions:

Under the study conditions, penetration of the constituent through mouse skin was approximately three times greater than that through human skin.

Executive summary:

A study was conducted to determine the dermal penetration potential of the constituent alpha-tocopherol using three human abdominal skin samples and three Skh:HR-1 mouse dorsal skin samples. The skin samples were mounted in Franz-type diffusion cells, with 0.785 cm² skin surface area exposed. The average cumulative penetration through human skin for the substance was 14 and 227 µg/cm2 after 2 and 24 h respectively. Using mouse skin, the average cumulative penetration of the test substance was 50 and 628 µg/cm2 after 2 and 24 h, respectively. Under the study conditions, penetration of the constituent through mouse skin was approximately three times greater than that through human skin (Fiume, 2002).