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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 601-489-9 | CAS number: 1176-81-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The study was conducted prior to implementation of the OECD test guidelines.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Fluocortolone
- EC Number:
- 205-811-5
- EC Name:
- Fluocortolone
- Cas Number:
- 152-97-6
- Molecular formula:
- C22H29FO4
- IUPAC Name:
- 6-fluoro-11,21-dihydroxy-16-methylpregna-1,4-diene-3,20-dione
- Details on test material:
- - Name of test material (as cited in study report): 6-alpha-fluoro-16-alpha-methyl-delta-1,4-pregnadiene-11ß, 21-diol-3, 20-dione (ZK10445)
- Lot/batch No.: 1008
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Caesarean-derived weanling albino rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Weight at study initiation: males: 93-95 g for the preliminary study and 157 g-208 g for the dose range finder, females: 88-91g for the preliminary study and 151 - 207 g for the dose range finder
- Housing: Individually
- Diet (e.g. ad libitum): Purina Laboratory Chow (meal) ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: 8 d
ENVIRONMENTAL CONDITIONS
The rats were individually housed in temperature-controlled quarters.
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- A basal diet was fed to all animals for the eight-day acclimation period. The drugs were then incorporated into the diet by means of a mechanical mixer to yield concentrations
required to provide the desired daily intake of compound. - Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- A. preliminary study: 10 days exposure plus 18 days post exposure time (resulting in 4 weeks test)
B. range finding study: 15 days - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.3 mg/kg bw/day (nominal)
- Remarks:
- dose range finder
- Dose / conc.:
- 1 mg/kg bw/day (nominal)
- Remarks:
- dose range finder
- Dose / conc.:
- 3 mg/kg bw/day (nominal)
- Remarks:
- dose range finder
- Dose / conc.:
- 3 mg/kg bw/day (nominal)
- Remarks:
- Preliminary study
- Dose / conc.:
- 9 mg/kg bw/day (nominal)
- Remarks:
- Preliminary study
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- Preliminary study
- No. of animals per sex per dose:
- A. preliminary study: 30/sex/dose
B. range finding study: 2/sex/dose - Control animals:
- yes, concurrent vehicle
- other: preliminary study: 9 mg/kg prednisolone as positive control.
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- >= 0.3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: BW gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
A. preliminary study: 15 animals receiving fluocortolone died in second week on treatment (13 rats of high dose group, 2 rats in mid dose group). Despite the cessation of test substance on 11th day further 16 animals (12 rats of high dose group, 3 rats of mid dose group, 1 rat of low dose group) died until end of study after 4 weeks. Decrease of body weight in week 1. Reduced bw gain until end of study. Reduced food consumption.
B. range finding study: All animals survived study period. Reduced bw gain in low dose group. Bw loss in mid and high dose groups.
Applicant's summary and conclusion
- Conclusions:
- In a preliminary 4 weeks study rats (30/sex/dose) were treated orally with 3, 9 or 50 mg/kg fluocortolone for 10 days and suviving animals were observed until end of study. 15 rats died during treatment period, additional 16 animals died in post exposure period. Animals showed decreased body weight and food consumption in week 1 and reduction of bw gain until end of study.
In a second range finding study rats (2/sex/dose) were treated orally with fluocortolone (0.3, 1.0, 3.0 mg/kg). All animals survived study period. Reduced bw gain in low dose group and bw loss in mid and high dose groups was observed.
The low adverse effect level was determined at the lowest dose level of 0.3 mg/kg. - Executive summary:
In a subchronic toxicity study (similar to OECD test guideline 407 but conducted prior to implementation of the test guidelines, Fluocortolon was administered to 30 albino white rats/sex/dose for the preliminary study and 2 albino white rats/sex/dose for the range finder study in diet, at dose levels of 0, 3, 9, and 50 mg/kg bw/day (preliminary study) and 0, 0.3, 1, and 3 mg/kg bw/day (range finder study).
In the preliminary 4 weeks study rats (30/sex/dose) were treated orally with 3, 9 or 50 mg/kg fluocortolone for 10 days and surviving animals were observed until end of study. 15 rats died during treatment period, additional 16 animals died in post exposure period. Animals showed decreased body weight and food consumption in week 1 and reduction of bw gain until end of study. In the range finder study rats were treated with 0.3, 1, and 3 mg/kg bw/day. The animals showed a decreased body weight gain from 1.0 mg/kg bw/day and at 3.0 mg/kg bw/day. An increased body weight gain was only observed at 0.3 mg/kg bw/day. Thus, based on these results the LOAEL is > 0.3 mg/kg bw/day.
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.