Registration Dossier
Registration Dossier
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EC number: 203-745-1 | CAS number: 110-19-0
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- year of publication: 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles Read-across hypothesis: for details please see read-across report in IUCLID section 13
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
- Principles of method if other than guideline:
- determination of dermal diffusion in vitro with Franz cell methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-butyl acetate
- EC Number:
- 204-658-1
- EC Name:
- N-butyl acetate
- Cas Number:
- 123-86-4
- Molecular formula:
- C6H12O2
- IUPAC Name:
- butyl acetate
- Details on test material:
- - Name of test material (as cited in study report): n-butyl acetate
- Analytical purity: > 99%
Constituent 1
- Radiolabelling:
- no
Administration / exposure
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Piglets (Duroc) that were either stillborn or died within 2 days of birth from commercial breeder
- Type of skin: skin from back and flank
- Preparative technique: dermatomed
- Thickness of skin (in mm): 0.39 +/- 0.08
- Membrane integrity check: yes: cross-membrane resistance
- Storage conditions: at - 20°C for 12 h
PRINCIPLES OF ASSAY
- Diffusion cell: Franz cell, model (no. 4G-01-00-09-05 Permeagear, Bethlehem, PA)
- Receptor fluid: physiological buffered saline with 6% PEG-20 oleyl ether
- Static system: yes
- Test temperature: 32°C
- Occlusion: yes
Results and discussion
Percutaneous absorption
- Remarks on result:
- other:
Any other information on results incl. tables
means +/- SD from 12 experiments:
lag time of penetration: 23 +/- 12 min
flux: 0.47 +/- 0.07 mg/cm2/h
diffusion coefficient: 24 +/- 14 x 10E8 cm2/s
permeability coefficient: 5.3 +/- 1.2 x 10E4 cm/h
Read-across justification: for details please see read-across report in IUCLID section 13
Applicant's summary and conclusion
- Conclusions:
- In vitro investigations on skin permeability of n-butyl acetate indicate that the test item has only a low tendency to penetrate the skin.
- Executive summary:
Skin permeabilityof n-butyl acetate was investigated in vitro using a Franz-Diffusion cell and viable skin from pigs. The flux was 0.47 +/- 0.07 mg/cm2/h, indicating that the test item has only a low tendency to penetrate the skin (Rauma, 2009).
The study is reliable with restrictions (RL2).
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