Registration Dossier
Registration Dossier
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EC number: 204-626-7 | CAS number: 123-42-2
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- In vitro dermal absorption rate testing of certain chemicals of interest to the Occupational Safety and Health Administration: summary and evaluation of USEPA's mandated testing
- Author:
- Fasano WJ, McDougal JN.
- Year:
- 2 008
- Bibliographic source:
- Regul Toxicol Pharmacol., 51(2):181-94. doi: 10.1016/j.yrtph.2008.04.005
- Reference Type:
- other:
- Title:
- In Vitro Dermal Absorption Rate Testing of Certain Chemicals of Interest to the Occupational Safety and Health Administration
- Author:
- US Environmental Protection Agency
- Year:
- 2 004
- Bibliographic source:
- Federal Register, 69 FR 22402, 22402 -22441 (https://federalregister.gov/a/04-9409)
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register, 69 FR 22402, 22402 -22441. "Test Rule; In Vitro Dermal Absorption Rate Testing of Certain Chemicals of Interest to the Occupational Safety and Health Administration"
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-hydroxy-4-methylpentan-2-one
- EC Number:
- 204-626-7
- EC Name:
- 4-hydroxy-4-methylpentan-2-one
- Cas Number:
- 123-42-2
- Molecular formula:
- C6H12O2
- IUPAC Name:
- 4-hydroxy-4-methylpentan-2-one
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- human
Administration / exposure
- Vehicle:
- water
- Duration of exposure:
- 10 and 60 min
- Doses:
- 25 mg/cm² (313 µl/cm² of a 80 mg/ml solution)
- No. of animals per group:
- minimum of six replicates represented by at least three donors (for each of the three experimental scenarios)
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: human cadaver
- Ethical approval if human skin: no data
- Type of skin: abdominal region
- Preparative technique: either dermatomed or heat-separated epidermal membranes (HEM)
- Thickness of skin: 200-500 µm
- Membrane integrity check: electrical resistance (impedance)
- Storage conditions: frozen (-20° C) for up to 3 months
- Justification of species, anatomical site and preparative technique:
PRINCIPLES OF ASSAY
- Diffusion cell: standard in vitro diffusion cell modeI, eilher static or flow-through
- Receptor fluid: no data
- Solubility of test substance in receptor fluid: yes
- Static system:
- Flow-through system:
- Test temperature: 32°C
- Humidity:
- Occlusion:
- Reference substance(s):
- Other: Kp = steady-state rate of absorption (in µg/ hr x cm² )/ concentration of the test substance (measured in µg/cm3) applied to the skin.
Results and discussion
- Dermal irritation:
- no effects
- Remarks:
- No change in pre- and post-dose electrical impedance (El) values for Kp, 10 minute and 60 min experiments
- Total recovery:
- Kp study: 89.6%
10 min: 90.8%
60 min: 91.7%
Percutaneous absorptionopen allclose all
- Time point:
- 10 min
- Dose:
- 25 mg/cm²
- Parameter:
- percentage
- Absorption:
- ca. 0.04 %
- Remarks on result:
- other: skin: 0.04%; recepto fluid < 0.001%
- Key result
- Time point:
- 60 min
- Dose:
- 25 mg/cm²
- Parameter:
- percentage
- Absorption:
- ca. 0.15 %
- Remarks on result:
- other: skin: 0.11%; receptor fluid: 0.04%
- Key result
- Time point:
- 24 h
- Dose:
- 25 mg/cm²
- Parameter:
- percentage
- Absorption:
- ca. 5.71 %
- Remarks on result:
- other: skin: 0.7%; receptor fluid: 5.01%
- Key result
- Time point:
- 8 h
- Dose:
- 25 mg/cm²
- Parameter:
- percentage
- Absorption:
- ca. 1 %
- Remarks on result:
- other: Extrapolated from the polynomial % absorption/exposure time curve y = 1E-06x² + 0,0021x + 0,0188 (R² = 1)
- Parameter:
- other: Kp
- Remarks:
- 5.77e-4 cm/h
- Dose:
- 25 mg/cm²
- Parameter:
- rate
- Absorption:
- 56.6 other: µg/cm²/h
- Time point:
- 60 min
- Dose:
- 25 mg/cm²
- Parameter:
- rate
- Absorption:
- 37.3 other: µg/cm²/h
Applicant's summary and conclusion
- Executive summary:
In vitro dermal penetration rate of diacetone alcohol, as permeability coefficient (Kp) and short-term dermal absorption rates at 10 and 60 min, was determined using human cadaver skin mounted in an in vitro diffusion cell model. Total recovery, based on liquid scintillation count data for total radioactivity, was between 89.6 and 91.7% of the applied dose. Skin penetration was 0.04, 0.15 and 5.71 % of the dose after 10 min, 60 min and 24 h, respectively. Kp was 5.77e-4 cm/h. From the polynomial % absorption/exposure time curve (y = 1E-06x² + 0,0021x + 0,0188, R² = 1), a skin penetration of 1% was estimated for a 8-hour exposure.
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