Registration Dossier
Registration Dossier
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EC number: 270-700-0 | CAS number: 68476-80-2 Complex combination obtained by steam distillation of mixed vegetable oils followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
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:
- 2 002
- 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
- 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
- Reference substance name:
- alpha-Tocopherol
- IUPAC Name:
- alpha-Tocopherol
- Details on test material:
- - Name of test material (as cited in study report): alpha-tocopherol
Constituent 1
Constituent 2
- 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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