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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 609-203-4 | CAS number: 36130-02-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- Deviations:
- not applicable
- 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:
- dog
- Strain:
- Beagle
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- other: cornstarch
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: capsules
DIET PREPARATION
The dosage was administered in gelatin capsules, six days per week, with the high level animals receiving half their dosage in the morning and half in the afternoon about four and one-half hours apart. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 54 weeks
- Frequency of treatment:
- daily, 6 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 3 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 9 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 4/sex/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- All of the dogs on
the 50 mg/kg dosage level of SH 742 died or were sacrificed in moribund condition within 16 weeks. Except for dog No. 4448 M in the partial sacrifice at 15 weeks, all of the dogs on the 9.0 mg/kg dosage level died or were sacrificed in moribund condition within 43 weeks. Dogs 4451 M and 4499 F on the 3.0 mg/kg dosage level were in the partial sacrifice at 15 weeks. Dogs 4395 M and 4555 M on this low level died during weeks 32 and 54, respectively. The other four dogs on the 3.0 mg/kg level survived until termination of the experiment. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- All of the animals on the 50 mg/kg dosage level ofthe test compound lost from 1.2 to 6.1 kilograms of bodyweight be fore being autopsied. Two of the males and three of the females on the 9.0 mg/kg level lost from 0.9 to 4.0 kilograms of body weight before being autopsied. Dog No. 4395 M on the 3.0,mg/kg level lost 1.4 kilograms and dog NO. 4555 M lost 0.6 kilogram prior to death. Each of the four 3.0 mg/kg animals that survived gained at least 1.0 kilogram of body weight more than any of the controls.
Effect levels
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- >= 3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
All dogs of the highest and of the medium dose level died or were sacrificed in moribund condition within 43 weeks (medium dose group) respectively 16 weeks (highest dose group). Two dogs of the low dose group died in weeks 32 and 54.
Toxic effects were seen after 3 weeks (high dose) or later (17-29 weeks for the low dose) with a distinct dose dependency. Increased mortality, decreased body weight and food consumption, slight to moderate polyuria and polydipsia, swollen neck lymph nodes, fat deposition in the subcutis, alopecia, (bloody) diarrhoea, vomiting, neurological effects, lowering of the body temperature, dehydration, head muscle degeneration and disturbance of the electrolyte balance occurred.
Atrophy of the lymphoreticular tissue was predominant with a concurrent decrease in blood leukocyte count and haemoglobin concentration and bone marrow hypocellularity. Serum alkaline phosphatase values were elevated proportional to dose.
Increased liver weight was correlated with an increased deposition of glycogen and pigment. The kidney, the adrenal glands, and the cartilages were likewise affected by degenerative and atrophic changes.
Applicant's summary and conclusion
- Conclusions:
- Dogs (4 males and 4 females per group) received fluocortolone orally at dose levels of 0, 3.0, 9.0 or 50 mg/kg body weight once daily for 54 weeks. All dogs of the highest and of the medium dose level died or were sacrificed in moribund condition within 43 weeks (medium dose group) respectively 16 weeks (highest dose group). Two dogs of the low dose group died in weeks 32 and 54.
Toxic effects were seen after 3 weeks (high dose) or later (17-29 weeks for the low dose) with a distinct dose dependency.
The LOAEL was determined at 3.0 mg/kg body weight, a NOAEL was not determined. - Executive summary:
In a study conducted comparable to OECD test guideline 452 (study performed prior to implementation of OECD guidelines) female and male Beagle dogs (4 males and 4 females per group) received fluocortolone orally at dose levels of 0, 3.0, 9.0 or 50 mg/kg body weight once daily for 54 weeks; 6 days/week. All dogs of the highest and of the medium dose level died or were sacrificed in moribund condition within 43 weeks (medium dose group) respectively 16 weeks (highest dose group). Two dogs of the low dose group died in weeks 32 and 54.
Toxic effects were seen after 3 weeks (high dose) or later (17-29 weeks for the low dose) with a distinct dose dependency. Increased mortality, decreased body weight and food consumption, slight to moderate polyuria and polydipsia, swollen neck lymph nodes, fat deposition in the subcutis, alopecia, (bloody) diarrhoea, vomiting, neurological effects, lowering of the body temperature, dehydration, head muscle degeneration and disturbance of the electrolyte balance occurred.
Atrophy of the lymphoreticular tissue was predominant with a concurrent decrease in blood leukocyte count and haemoglobin concentration and bone marrow hypocellularity. Serum alkaline phosphatase values were elevated proportional to dose.
Increased liver weight was correlated with an increased deposition of glycogen and pigment. The kidney, the adrenal glands, and the cartilages were likewise affected by degenerative and atrophic changes.
The LOAEL was determined at 3.0 mg/kg body weight, a NOAEL could not be determined.
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.