Registration Dossier
Registration Dossier
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EC number: 218-235-4 | CAS number: 2090-05-3
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: according to guideline, review article, non GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Benzoic acid
- EC Number:
- 200-618-2
- EC Name:
- Benzoic acid
- Cas Number:
- 65-85-0
- Molecular formula:
- C7H6O2
- IUPAC Name:
- Benzoic acid
- Details on test material:
- No data given.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: cryopreserved human abdominal skin
- Age at study initiation: aged 29–53 years (average 39 ± 7.4)
No information provided
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: The receptor fluid consisted of a physiological salt solution (0.9% NaCl w/v) containing 0.01% sodium azide and 6% polyoxyethylene oleyl ether
- Duration of exposure:
- Finite dose experiments: 8 h
- Doses:
- - Nominal doses: 33 mg/mL(0.19)
- Dose volume: 16 μL aqueous dose solution/cm2
- Rationale for dose selection: The highest test concentrations were selected based on maximum solubility in water. - No. of animals per group:
- 4 of the epidermal membranes per test group
- Control animals:
- no
- Details on study design:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): To ensure also lipophilic test substances would be readily soluble in it.
TEST SITE
- Area of exposure: 0.64 cm2
SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: no
REMOVAL OF TEST SUBSTANCE
- Washing procedures and type of cleansing agent: Washing off the test substance using four cotton swabs humidified with a 3% Teepol solution
- Time after start of exposure: 8 h
ANALYSIS
- Method type(s) for identification: liquid scintillation counting (LSC)
No information provided - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: nine female donors
- Type of skin: cryopreserved human abdominal skin
- Preparative technique: Epidermal membranes were used, which were prepared by incubating skin overnight in 2 M NaBr solution in saline, after which the epidermis was peeled from the dermis using forceps.
- Membrane integrity check: Integrity of the epidermal was assessed by determining the permeability coefficient (Kp) of tritiated water.
PRINCIPLES OF ASSAY
- Diffusion cell: static diffusion cells using cryopreserved human abdominal skin (exposed area 0.64 cm2)
- Receptor fluid: The receptor fluid (total volume 1.2 mL) consisted of a physiological salt solution (0.9% NaCl w/v) containing 0.01% sodium azide and 6% polyoxyethylene (20) oleyl ether.
- Solubility od test substance in receptor fluid: 33 mg/mL
- Static system: in static diffusion cells
No information provided
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- No information provided
- Total recovery:
- - Total recovery: 98 ± 0.8%
No data given.
Percutaneous absorptionopen allclose all
- Dose:
- 10 μL
- Parameter:
- percentage
- Absorption:
- 48 %
- Remarks on result:
- other: 8h
- Remarks:
- Measured
- Parameter:
- percentage
- Absorption:
- 93 %
- Remarks on result:
- other: QSAR prediction
- Conversion factor human vs. animal skin:
- not applicable
Any other information on results incl. tables
Recovery of the label is 98%.
Applicant's summary and conclusion
- Conclusions:
- The measured absorption of test substance in an in vitro test with human skin was 48±7%.
- Executive summary:
The finite dose experiment was made according to OECD Guideline 428.The test substance was exposed to cryopreserved human abdominal skin for 8 hours with concentration of 33 mg/mL. 14C-radioactivity, penetration rate and recovery were calculated.
The measured absorption of test substance is 48±7% with a revovery of radioactivity of 98%.
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