Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-551-0 | CAS number: 533-00-6
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%.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
