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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1965
- 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:
- 1 965
- Report date:
- 1965
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- Remarks:
- pre-guideline study
- Principles of method if other than guideline:
- - Principle of test: The test item was once orally applied to male and female Wistar rats in doses of 45 mg/kg, 125 mg/kg, 180 mg/kg, 250 mg/kg, 360 mg/kg, 500 mg/kg, 720 mg/kg, and 2000 mg/kg. The animals were observed for further 8 days. At the end of the observation period the animals were sacrificed if no premature death occurred and the exterior and interior appearance was recorded regardless wheter the animals died before the end of the observaqtion period or not.
- GLP compliance:
- no
- Remarks:
- study conducted prior to implementation of the respective OECD test guideline
- Test type:
- standard acute method
- 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: Tierzüchter Wulf (not further specified)
- Weight at study initiation: 80-110 g
- Fasting period before study: 16- 18 hours
- Housing: conventional (1 animal per cage) in macrolon cages
- Diet (ad libitum): Altromin R, ad libitum
- Water (ad libitum): tap water, ad libitum
- Acclimation period: 4-5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 55-65
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: gummi arabicum ad aqua dest.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 620mg, 2.5g and 10g in 100 mL
- Amount of vehicle (if gavage): dependent on concentration, for 45 mg/kg : 0.72 mL/100g bw; for 125 mg/kg: 0.5 mL/100 g bw; for 180 mg/kg: 0.72 mL/100 g bw; for 250 mg/kg: 1.0 mL/100g bw; for 360 mg/kg: 1.4 mL/100 g bw; for 500 mg/kg: 2.0 mL/100 g bw; for 720 mg/kg: 2.8 mL/100 g bw; for 2.0 g/kg: 2.0 mL/100 g bw.
DOSAGE PREPARATION (if unusual): suspension
- Doses:
- 45, 125, 180, 250, 360, 500, 720 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8 days
- kind of observations: clinical signs, mortality
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology - Statistics:
- The LD50 was determined by the method of Litchfied and Wilcoxon.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 245 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 173 - <= 347
- Mortality:
- Animals of the dose level of 125 mg/kg bw and above died between 2 and 8 days after application (details see table 1).
- Clinical signs:
- other: After single oral administration animals developed apathy from 125 mg/kg upwards.
- Gross pathology:
- At autopsy, hydrops ascites and fibrinous peritonitis, changes in the gastrointestinal tract such as ulcers, erosions and thickening of the gastric mucous membrane were observed. Also haemorrhagic mesenteric lymph nodes, necrobiosis of the liver, abscesses and subacute pneumonia in the lungs were noted. Adhesions of organs contained in the abdominal cavity were found.
Any other information on results incl. tables
Table 1: Number of dead animals per dose group after single oral application of fluocortolone (ZK 10445) to rats (males and females combined):
Dose [mg/kg] | No of dead animals/ No of treated animals |
50 | 0/10 |
125 | 3/10 |
180 | 5/10 |
250 | 7/10 |
360 | 7/10 |
500 | 8/10 |
720 | 8/10 |
2000 | 9/10 |
Calculation of LD50 (Litchfield and Wilcoxon) | ||||||
Dose (mg/kg) | T/E | %W | %E | D | Chi² | t |
45 | 0/10 | 0 | 3 | 2.0 | 0.013 | ----- |
125 | 3/10 | 30 | 23 | 7.0 | 0.025 | 5-7d |
180 | 5/10 | 50 | 37 | 13.0 | 0.072 | 3-7d |
250 | 7/10 | 70 | 51 | 19.0 | 0.140 | 4-8d |
360 | 7/10 | 70 | 67 | 3.0 | 0.004 | 4-8d |
500 | 8/10 | 80 | 79 | 1.0 | ----- | 3-7d |
720 | 8/10 | 80 | 88 | 8.0 | 0.060 | 4-7d |
2000 | 10/10 | 100 | 99.1 | 0.6 | 0.004 | 2-5d |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral toxicity (LD50) of fluocortolone in male and female rats was determined to be 245 mg/kg.
From 125 mg / kg onwards sporadically, and in higher doses more accumulated, partly considerable apathy observed. The death occurred between 2 and 8 days after application. In those animals that prematurely died or were killed at 125 mg / kg miliary gray-white foci found in the liver at autopsy.
In higher doses severe gastrointestinal alterations (ulcers, bleeding, hyperemia, bloody infiltration of the mesenterial lymph nodes) and liver dystrophies) (color and consistency changes, multiple gray-white foci) were observed. As consequences hydrops ascites and fibrinous peritonitis was observed. The pathological anatomical findings primarily point to the damaging effects of the substance in the gastrointestinal tract and suggest that secondary diseases and autointoxications are a major contributor to the cause of death. This considerably limits the informative value of the LD50 p.o. as indicator for the actual lethal effect of the substance. However, based on the calculation according to Litchfield and Wilcoxon the oral LD50 for rats is 245 mg/kg bw (173 – 347 mg/kg bw). - Executive summary:
In an acute oral toxicity study similar to OECD test guideline 401 (the study was conducted prior to implementation of this guideline), groups of fasted, Wistar rats (5/sex) were given a single oral dose of Fluocortolon in 5% gummi arabicum at doses of 45, 125, 180, 250, 360, 500, 720 and 2000 mg/kg bw and observed for 8 days.
Oral LD50 Females/Males = 245 mg/kg bw (95% C.I. 173 – 347 mg/kg)
After single oral administration of fluocortolone in doses of 45, 125, 180, 250, 360, 500, 720 and 2000 mg/kg bw to male and female rats (5/sex/group) apathy was found as clinical sign. At autopsy, hydrops ascites and fibrinous peritonitis were observed. Furthermore, changes in the gastrointestinal tract such as ulcers, erosions and thickening of the gastric mucous membrane were detected. Haemorrhagic mesenteric lymph nodes, necrobiosis of the liver, abscesses and subacute pneumonia in the lungs were noted. Adhesions of organs contained in the abdominal cavity were found. Animals of the dose level of 125 mg/kg bw and above died between 2 and 8 days after application.
Fluocortolon is of MODERATE Toxicity based on the LD50 in female and male Wistar rats, thus, Fluocortolon is classified in Category 3 for acute oral toxicity according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
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