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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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 9. Mar to 7. Apr 1971
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Rats (10/sex/dose) were treated daily subcutaneously with test substance over a period of 4-5 weeks and sacrificed afterwards. Different hematological and biochemical examinations were performed. Macroscopic and histological changes were recorded.
- 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:
- (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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Züchter Mus Rattus AG.
- Weight at study initiation: 150-245 g
- Housing: individually in macrolon type II cages
- Diet (e.g. ad libitum): Altromin ad libitum
- Water (e.g. ad libitum): Tap Water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- not specified
- Details on exposure:
- The application volume was 0.1 mL/100 g, control animals received the vehicle in the same manner.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 7 days/week for 4 to 5 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.002 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 0.02 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 0.2 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Mortality:
- no mortality observed
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- >= 0.002 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: increased lipid concentration in zona fasciculata in adrenal gland (m and f), reduced gamma-globulin fraction in females
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Starting at low dose animals developed increased lipid concentration in zona fasciculata in adrenal gland and reduced gamma-globulin fraction in electrophoresis. At higher dose (0.02 mg/kg) rats developed reduced body weight gain, increased sodium excretion. At 0.2 mg/kg additionally increased chlorid excretion, reduced absolute thymus, lymph node and adrenal gland (also relative) weights, follicle atrophy and reduced lymphocytes in spleen, also involution of thymus with pyknosis of thymocytes and atrophy in adrenal gland and increased erythropoesis were noted. In addition haemorrhages around the location of application were detected.
Applicant's summary and conclusion
- Conclusions:
- LOAEL: 0.002 mg/kg bw; NOAEL could not be identified.
Rats (10/sex/group) were treated subcutaneously with fluocortolone at a dose level of 0, 0.002, 0.02, or 0.2 mg/kg once daily for 4-5 weeks. Findings were mainly reduced body weight gain, effects on thymus, adrenal gland and spleen. In addition
haemorrhages around the location of application were detected. - Executive summary:
In a repeated dose toxicity study (conducted prior to implementation of OECD test guidelines) male and female Wistar rats (10/group) were administered Fluocortolon subcutaneously in concentrations of 0, 0.002, 0.02, and 0.2 mg/kg bw over a period of 4-5 weeks, 7 days a week. Findings were mainly reduced body weight gain, effects on thymus, adrenal gland and spleen. In addition haemorrhages around the location of application were detected. Based on the observed increased lipid concentration in the zona fasciculata (adrenal gland) and a reduced gamma-globulin fraction in female rats starting already at a dose of 0.002 mg/kg bw the LOAEL was set to 0.002 mg/kg bw, a NOAEL could not be identified.
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