Registration Dossier
Registration Dossier
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EC number: 202-259-7 | CAS number: 93-58-3
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- An experimentally based approach for predicting skin permeability of chemicals and drugs using a membrane-coated fiber array
- Author:
- Xia X-R, Baynes RE, Monteiro-Riviere NA, Riviere JE
- Year:
- 2 007
- Bibliographic source:
- Toxicology and Applied Pharmacology 221: 320-8
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- With a membrane-coated fiber (MCF) technique relative strengths of the molecular interactions (the partition coefficients) were investigated. A multiple MCF polymer membranes consisted of polydimethylsiloxane (PDMS) for lipophilic, CarboWax (Wax) for hydrogen bonding and polyacrylate (PA) for π*-electron interactions. With porcine skin, experimental skin permeability log (kp) was determined, which were compared with estimated skin permeability from an empirical approach.
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl benzoate
- EC Number:
- 202-259-7
- EC Name:
- Methyl benzoate
- Cas Number:
- 93-58-3
- Molecular formula:
- C8H8O2
- IUPAC Name:
- methyl benzoate
- Details on test material:
- - Name of test material (as cited in study report): Methyl benzoate
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- pig
- Strain:
- other: Yorkshire
- Sex:
- female
Administration / exposure
- Control animals:
- no
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: porcine skin of weaning
- Type of skin: dorsal area
- Preparative technique: dermatomed
- Thickness of skin (in mm): 0.35
- Membrane integrity check: no data
- Storage conditions: no data
- Justification of species, anatomical site and preparative technique: no data
PRINCIPLES OF ASSAY
- Diffusion cell: two-compartment Teflon flow-through diffusion cell
- Receptor fluid: Krebs-Ringer bicarbonate buffer spiked with dextrose and bovine serum albumin (4.5 %)
- Solubility of test substance in receptor fluid: no data
- Static system: Brinkman circulator
- Flow-through system: 4.0 mL/h
- Test temperature: 37 °C
- Humidity: no data
- Occlusion: no data
- Reference substance(s): no data
- Other: pH was maintained between 7.3 and 7.5
Results and discussion
Percutaneous absorption
- Remarks on result:
- other: Under experimental conditions in vitro with porcine skin, methyl benzoate was metabolised. The skin permeability log(kp) was estimated from refined Potts and Guy models in USEPA Supplemental Guidance for Dermal Risk Assessment and was -2.16 cm/h.
Any other information on results incl. tables
Three sets of partition coefficients (logK) were measured with three MCFs (PDMS, PA and Wax) for Methyl benzoate and were 1.882, 2.015 and 1.561, respectively.
In the in vitro experiment with porcine skin, the receptor solution was formulated to mimic the microvascular circulation of the skin, composed of 4.5 % bovine serum albumin in a Krebs-Ringer bicarbonate buffer with dextrose (0.12 %). Since Methyl benzoate was metabolized under the experimental conditions, the skin permeability value log(kp) was not obtained. However, skin permeability log(kp) was estimated from refined Potts and Guy models in USEPA Supplemental Guidance for Dermal Risk Assessment and was -2.16 cm/h.
Applicant's summary and conclusion
- Conclusions:
- Methyl benzoate was metabolized under the experimental conditions in vitro, therefore the skin permeability value log(kp) was not obtained. The skin permeability log(kp) was estimated by empirical approach from refined Potts and Guy models in USEPA Supplemental Guidance for Dermal Risk Assessment and was -2.16 cm/h.
- Executive summary:
The MCF array approach is used to stimulate the biological processes, where passive diffusion is the rate limiting transport mechanism. The partition coefficients were determined for Methyl benzoate by multiple MCF membranes. For example, logK through polydimethylsiloxane (PDMS), where lypophilic interactions were measured was 1.882, logK through polyacrylate (PA), where π*-electron interactions were measured was 2.015 and logK through CarboWax (Wax), where hydrogen bonding were measured was 1.561.
Under experimental conditions in vitro with porcine skin, methyl benzoate was metabolised, therefore the skin permeability coefficient log (kp) was not determined. Using the empirical approach from refined Potts and Guy models in USEPA Supplemental Guidance for Dermal Risk Assessment, the log(kp) was calculated to be -2.16 cm/h.
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