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EC number: 200-001-8 | CAS number: 50-00-0
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- validity restricted due to the use of high concentration inducing local toxic effects (corrosion at the high dose level) and exclusion of radioactivity in deeper skin layers for calculation of absorption (underestimation of absorption rate at low dose).
Data source
Reference
- Reference Type:
- publication
- Title:
- The in vitro permeability of human skin to benzene, ethylene glycol, formaldehyde, and n-Hexane
- Author:
- Loden M
- Year:
- 1 986
- Bibliographic source:
- Acta Pharmacol Toxicol 58: 382-389
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Formaldehyde
- EC Number:
- 200-001-8
- EC Name:
- Formaldehyde
- Cas Number:
- 50-00-0
- Molecular formula:
- C H2 O
- IUPAC Name:
- formaldehyde
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C-formaldehyde
Test animals
- Species:
- human
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Duration of exposure:
- 15 h
- Doses:
- no data
concentration: 3.7% or 37% - No. of animals per group:
- 5 trials with skin samples for each concentration
- Details on in vitro test system (if applicable):
- Permeability of human skin to 14C-formaldehyde studied using excised full skin in a flow-through (5 mL/h) diffusion cell at 30°C. Radioactivity measured by scintillation counting. Resorption related to radioactivity in receptor fluid (radioactivity in skin not included) although radioactivity in tangential cryo-slices of the skin (thickness: 2 mm) was measured after 0.5 or 15 hours of exposure.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- The dermal absorption was 16.7 µg/cm²/h using 3.7% formalin and 319 µg/cm²/h using 37% formalin (local corrosive effects assumed). Exclusion of radioactivity in deeper skin layers for calculation of absorption.
- Total recovery:
- no data
Applicant's summary and conclusion
- Executive summary:
Comparable to Guideline study; validity restricted due to the use of high concentration inducing local toxic effects (corrosion at the high dose level) and exclusion of radioactivity in deeper skin layers for calculation of absorption (underestimation of absorption rate at low dose).
Permeability of human skin to 14C-formaldehyde studied using excised full skin in a flow-through (5 mL/h) diffusion cell at 30°C. The dermal absorption was 16.7 µg/cm²/h using 3.7% formalin and 319 µg/cm²/h using 37% formalin.
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