Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 205-811-5 | CAS number: 152-97-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- other: expert statement
- Adequacy of study:
- other information
- Study period:
- not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well reported expert statement
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Healthy volunteers and psoriasis patients were exposed to fluocortolone cremes (0.25% w/w fluocortolone) for 1 to 24 hours. Skin was stripped 20 times afterwards to determine amount of resorbed substance.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Fluocortolone
- EC Number:
- 205-811-5
- EC Name:
- Fluocortolone
- Cas Number:
- 152-97-6
- Molecular formula:
- C22H29FO4
- IUPAC Name:
- (1S,2R,3aS,3bS,5S,9aR,9bS,10S,11aS)-5-fluoro-10-hydroxy-1-(2-hydroxyacetyl)-2,9a,11a-trimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- Details on test material:
- - Name of test material (as cited in study report): fluocortolone (ZK 10445)
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Strain:
- other: healthy volunteers and psoriasis patients
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- other: open and occlusive dressing
- Vehicle:
- other: mainly water based
- Duration of exposure:
- 1, 2, 4 and 8 hours on healthy volunteers;
25 hours on psoriasis patients - Doses:
- 0.25% w/w fluocortolone creme was used. Amount applied varied.
- No. of animals per group:
- 11 volunteers,
number of psoriasis patients not reported - Control animals:
- no
Results and discussion
Percutaneous absorptionopen allclose all
- Dose:
- no data
- Parameter:
- percentage
- Absorption:
- ca. 44 %
- Remarks on result:
- other: 8 hours exposure
- Remarks:
- healthy volunteers
- Parameter:
- percentage
- Absorption:
- ca. 65 %
- Remarks on result:
- other: 24 hours
- Remarks:
- psoriasis patients
- Conversion factor human vs. animal skin:
- no conversion factor needed
Any other information on results incl. tables
The resorption rate increased with increasing exopsure time.
After 8 hours exposure a dermal penetration rate of 44% in mean was found. After 12 and 20 times skin stripping the penetration rate could be increased to 10 and 20 %, respectively. No relevant differences between occlusiv and open application was found.Psoriasis patients treated 24 hours had dermal resorption rates of 65 % (SD 5%).
Fatty cremes had approximately half of the penetration rates of water based cremes.
Applicant's summary and conclusion
- Conclusions:
- Dermal penetration rate of fluocortolone in humans (healty volunteers) is ca 44%.
- Executive summary:
Dermal absorption of fluocortolone creme as emulsion was tested on eleven healthy volunteers at different time points. It was shown that the resorption rate was increased with increasing exopsure time. After 8 hours exposure a dermal penetration rate of 44% in mean was found. After 12 and 20 times skin stripping the penetration rate could be increased to 10 and 20 %, respectively. Relevant differences between occlusiv and open application of test substance was not seen. When psoriasis patients were treated 24 hours with fluocortolone creme resorption rates of 65 % (5% SD) were found. Testing of water-based and fat-based cremes revealed that fatty cremes have approximately half of the penetration rate compared to water based cremes.
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.