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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- other: expert statement
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: expert opinion
- Adequacy of study:
- other information
- Executive summary:
Overall there is proven broad exposure related to the therapeutic topical use of fluocortolone and related substances and there is a very low incidence of positive patch test reactions compared to the very substantial therapeutic use in patients with skin diseases. Therefore based on the available reliable and relevant human data the assessment of the skin sensitization potential (hazard identification) is possible. Based on all available data fluocortolone and structurally related substances are unlikely to be significant skin sensitizers and the criteria for classification are not met.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- 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"). - 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).
- 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 %).
- 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 %).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- 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"). - Type of sensitisation studied:
- skin
- Study type:
- other: study with patients
- Principles of method if other than guideline:
- Patch tests were performed using Finn chambers® on Scanpor® tape, left on the skin of the back for 48 h. The patch tests were read at 2 and 4 days. Patients were asked to return for a further reading if they developed a reaction after 4 days. Reactions were scored as recommended by the International Contact Dermatitis Research Group, and were considered positive when a palpable erythematous (+) reaction or greater was present.
- Executive summary:
The allergic potential of diflucortolone valerate has been investigated extensively in a risk group of 96 patients with allergic contact dermatitis induced by hydrocortisone. While , as expected, there were frequent positive patch test reactions to hydrocortisone-17-butyrate (43.8 %) and budesonide (28.1 %), a cross-reaction with diflucortolone valerate was rare (1.2 %).
A patch test with diflucortolone valerate in patients allergic to hydrocortisone revealed only a few cases with positive skin reactions (1.2 %).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- 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"). - Type of sensitisation studied:
- skin
- Study type:
- case report
- Principles of method if other than guideline:
- not specified
- Results of examinations:
- A patch test with diflucortolone valerate (TemetexR ointment) in a female patient with a budesonide allergy showed no reactions at D2, D3 and D4.
- Executive summary:
A 54-year old female patient with a budesonide allergy was patch tested to diflucortolone valerate (TemetexR ointment). No reactions were observed at D2, D3 and D4.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- May 1992 to Dec 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"). - 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).
- Results of examinations:
- Of 106 patients tested with diflucortolone valerate, only 3 patients (2.83 %) were positive.
- Executive summary:
2123 patients attending a contact dermatitis clinic were patch tested with a series of six glucocorticoids, in parallel with a standard series, and other relevant investigations. 127 patients were allergic to one or more glucocorticoids, mainly to tixocortol pivalate (96), hydrocortisone butyrate (51), budesonide (47) or betamethasone valerate (11). Of 106 patients tested with diflucortolone valerate, only 3 patients (2.83 %) were positive.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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