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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-825-4 | CAS number: 378-44-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- other: in vitro hapten-specific sensitization method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Experimental study for the development of an in vitro test for contact allergens. 1. Primary activation of hapten-specific T cells by hapten-conjugated epidermal cells.
- Author:
- Yokozeki, H.; Katayama, I.; Nishioka, K.
- Year:
- 1 995
- Bibliographic source:
- Int Arch Allergy Immunol 1995, 106, 394-400.
- Reference Type:
- secondary source
- Title:
- Experimental study for the development of an in vitro test for contact allergens. 2. Comparison of the in vitro sensitization test with the guinea pig maximization test for contact allergens.
- Author:
- Arimura, M.; Yokozeki, H.; Katayama, I.; Nakamura, T.; Masuda, M.; Nishioka, K.
- Year:
- 1 998
- Bibliographic source:
- Int Arch Allergy Immunol 1998, 115, 228-234.
Materials and methods
- Principles of method if other than guideline:
- Mono-layer cultures of Pam 212 cells were incubated with test chemicals (15 min @ 37 °C), washed, then fixed with 3% paraformaldehyde. T cells from non-sensitized mice which had been depleted of autoreactive cells, along with spleen derived macrophages, were cultured with the chemically-modified Pam 212 cells for 5 days. The T cells were then harvested and re-stimulated with mitomycin c treated, hapten-conjugated spleen cells at an R:S of 5:1 for 3 days. A stimulation index (SI) was calculated by dividing the DPM obtained in the presence of hapten modified spleen cells by that obtained in the presence of unmodified spleen cells. A number of chemicals were tested in this culture system including two strong sensitizers (10 mM TNBS, 10 μg/ml DNFB, 0.005% oxazolone, and fluorescein isothiocyanate), two potent sensitizers (2.5 mg/ml p-PD, 2.5% nickel chloride, and 2.5% potassium dichromate), two corticosteroids (0.1% betamethasone and 0.1% budesonide) and one irritant (2.5% methyl salicylate). The SIs produced by the strong sensitizers were approximately 4.0 while the potent sensitizers SIs were around 2.0-2.5.
Betamethasone was able to achieve a SI of 0.98±0.11, lower of many nonsensitizers or irritant compounds. - GLP compliance:
- not specified
- Type of study:
- other: in vitro hapten-specific sensitization method
Test material
- Reference substance name:
- Betamethasone
- EC Number:
- 206-825-4
- EC Name:
- Betamethasone
- Cas Number:
- 378-44-9
- Molecular formula:
- C22H29FO5
- IUPAC Name:
- 9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Positive control substance(s):
- other: Oxazolone
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: In vitro study
- Hours after challenge:
- 72
- Group:
- other: In vitro study
- Dose level:
- solution at 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Negative result
- Remarks on result:
- other: Reading: other: In vitro study. . Hours after challenge: 72.0. Group: other: In vitro study. Dose level: solution at 0.1%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: Negative result.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Because of the SI obtained for betamethasone (0.98) is lower than 3, with this assay can be excluded the sensitisation potential of betamethasone.
Although this study does not follow the OECD guidelines, the results were considered reliable. Furthermore, the method has been further confirmed by an additional study with more chemicals investigated.
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.