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Toxicological information

Dermal absorption

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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

Constituent 1
Chemical structure
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).

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