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Diss Factsheets
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EC number: 613-915-0 | CAS number: 66233-43-0
- 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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 25. June to 17. July 1969
- 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:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Male mice received a single dose of test substance subcutaneously and were sacrificed after observation period of 23 days.
- 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): fluocortolone (ZK10445)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Spiegel, no further information
- Weight at study initiation: 18-24 g
- Fasting period before study: 19 h
- Housing: conventional in groups of 5 animals in Macrolon cages type II
- Diet (e.g. ad libitum): Altromin R, ad libitum
- Water (e.g. ad libitum): Tap Water, ad libitum
- Acclimation period: 12 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 55-65
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- Preparation of suspension: Microcrystalsuspension made of 0.5 g carboxymethylcellulose in Aqua dest. as vehicle and 4g of test item
Applied volume:
360 mg/kg = 0.18 mL/20 g
500 mg/kg = 0.25 mL/20 g
720 mg/kg = 0.36 mL/20 g
1000 mg/kg = 0.5 mL/20 g
1440 mg/kg = 0.72 mL/20 g
2000 mg/kg = 1.0 mL/20 g - Doses:
- 360, 500, 720 1000, 1440 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 10/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 23 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, other: Gross pathology - Statistics:
- Probit analysis
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 811 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 689 - <= 953
- Remarks on result:
- other: Probit analysis
- Mortality:
- Mortality occurred at animals of the 500 mg/kg dose group (1 animal at day 4) and increased with increasing dosage. 720 mg/kg group: 2 animals after 15 and 18 days; 1000 mg/kg group: 2 animals on day 10, 2 animals on day 11, 3 animals on day 12, 1 animal at day 17.
1440 mg/kg group: 3 animals on day 3; 2 animals on day 4; 1 animals on day 5; 2 animals on day 7; 2 animals on day 12.
2000 mg/kg group: 7 animals on day 3; 2 animals on day 4 and 1 animal on day 11. - Clinical signs:
- The most prominent clinical sign was apathy in different degrees of strengths.
- Body weight:
- not reported
- Gross pathology:
- Prematurely died animals: Substance residues in the subcutis in the application area; thickening of the cutaneous lining of the stomach; bleeding in the lining of the glandular stomach; discoloration, decrease in consistency, bleeding and submilar gray-white foci in the liver.
Sacrificed animals: Substance residues, bleeding and abscess formation in the subcutis at the application area; scabbed areas of skin inside and outside the application area; discoloration, reduced consistency and miliary gray-white foci in the liver.
Any other information on results incl. tables
After application apathy was found in the animals starting in low dose group. At autopsy, a part of the test substance remained in the subcutis at the application side, also bleeding and abscesses in the subcutis were detected. In the gastrointestinal tract, changes such as ulcers and bleeding in the gastric mucous membrane were noted. Furthermore discoloration, bleeding and grey-white foci in the liver were observed. Animals of dose group 500 mg/kg and above died between 3 and 18 days after application.
Number of death animals per dose group:
Dose [mg/kg] | No of death animals/ all animals per group |
360 | 0/10 |
500 | 3/10 |
720 | 5/10 |
1000 | 7/10 |
1440 | 7/10 |
2000 | 9/10 |
Applicant's summary and conclusion
- Conclusions:
- The acute subcutanous toxicity (LD50) of fluocortolone in male mice is 811 mg/kg bw. After single subcutaneous administration of fluocortolone in the doses of 360, 500, 720 1000, 1440 and 2000 mg/kg bw to male mice (10/group) apathy was found as clinical sign. At autopsy, a part of the test substance remained in the subcutis at the application side, also bleeding and abscesses in the subcutis were detected. In the gastrointestinal tract, changes such as ulcers and bleeding in the gastric mucous membrane were noted. Furthermore discoloration, bleeding and grey-white foci in the liver were observed. Animals of dose group 500 mg/kg and above died between 3 and 18 days after application.
- Executive summary:
In an acute oral toxicity study, groups of fasted, NRMI mice (10 males/group) were given a single subcutaneous dose of Fluocortolon in CMC at a doses of 360, 500, 720 1000, 1440 and 2000 mg/kg bw and were observed for 23 days.
The LD50 value was determined by Probit-analysis: 811 mg/kg bw (95% C.I.: 689 – 953 mg/kg bw)
After single subcutaneous administration of fluocortolone in the doses of 360, 500, 720 1000, 1440 and 2000 mg/kg bw to male mice (10/group) apathy was found as clinical sign. At autopsy, a part of the test substance remained in the subcutis at the application side, also bleeding and abscesses in the subcutis were detected. In the gastrointestinal tract, changes such as ulcers and bleeding in the gastric mucous membrane were noted. Furthermore discoloration, bleeding and grey-white foci in the liver were observed. Animals of dose group 500 mg/kg and above died between 3 and 18 days after application.
Fluocortolon cannot be classified based on the results presented here due to the application site chosen. However, the results are useful as supporting information.
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