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EC number: 611-173-2 | CAS number: 54605-02-6
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1992 to 1993
- Justification for type of information:
- JUSTIFICATION FOR READ-ACROSS FROM SUPPORTING SUBSTANCE (STRUCTURAL ANALOGUE OR SURROGATE)
For bromhydrin-valerate (CAS No. 54605-02-6) no skin sensitisation data in animals or humans are available. Therefore, human skin sensitisation data of diflucortolone-21-valerate (CAS No. 59198-70-8) were used since these data are regarded as representative. In diflucortolone-21-valerate the bromine atom in position 9 of the target molecule (bromhydrin-valerate) is replaced by a fluorine atom. No other changes in the molecule occured. No relevant toxicological effects are expected by the change of a halogen atom (Br) versus another (F). A search for structure-analogue substances using the QSAR OECD Toolbox 3.4 recommended diflucortolone-21-valerate as one out of 8 category substances for a read-across approach (for additional information see QSAR OECD Toolbox Report on Bromhydrin-valerat in "Attached justification").
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- other: study with patients
- Principles of method if other than guideline:
- Tests were performed using Finn chambers on Scanpor tape left on the skin of the back for 2 days. The patch tests were read at 2 and 4 days, and reactions were scored in accordance with the International Contact Dermatitis Research Group guidelines (Wilkinson DS et al. (1970): Terminology of contact dermatitis. Acta Dermato-venereologica 50, 287-292).
Test material
- Reference substance name:
- 6α,9-difluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-valerate
- EC Number:
- 261-655-8
- EC Name:
- 6α,9-difluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-valerate
- Cas Number:
- 59198-70-8
- Molecular formula:
- C27 H36 F2 O5
- IUPAC Name:
- 6 α,9-Difluoro-11 β-hydroxy-16 α-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione
Constituent 1
Results and discussion
- Results of examinations:
- For diflucortolone valerate the relative number of allergic reactions was 1.15 %, compared to hydrocortisone (30.76 %), hydrocortisone-17-butyrate (16.34 %), budesonide (15.06 %) or betamethasone valerate (3.52 %).
Applicant's summary and conclusion
- Executive summary:
The authors demonstrated that the number of glucocorticoids allergic reactions is dependent on usage and the intrinsic ability of the glucocorticoid to degrade and bind to arginine. For diflucortolone valerate the relative number of allergic reactions was 1.15 %, compared to hydrocortisone (30.76 %), hydrocortisone-17-butyrate (16.34 %), budesonide (15.06 %) or betamethasone valerate (3.52 %).
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