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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 16. Jan 1975 to 09. Apr 1975
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- 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): Fluocortolon (ZK 10445)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder Scheele, Büderich
- Weight at study initiation: 2.4 - 4.4 kg
- Housing: The animals were kept for the whole period of the study in cages with perforated bottoms
- Diet (e.g. ad libitum): ad libitum, Ssniff
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light):12/12
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: ointment
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: no data
- Length of cohabitation: no data
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Any other deviations from standard protocol: no - Duration of treatment / exposure:
- on the gestation days 6 -18 (13 days)
- Frequency of treatment:
- once daily
- Duration of test:
- until day 28 of pregnancy. Termination by caesarean section.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 500 mg/kg bw/day
- Remarks:
- as ointment with a concentration of 0.5%, corresponding to 12.5 mg/kg bw of the test item
- Dose / conc.:
- 500 mg/kg bw/day
- Remarks:
- as ointment with a concentration of 0.5%, corresponding to 2.5 mg/kg bw of the test item
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- as ointment with a concentration of 0.5%, corresponding to 0.25 mg/kg bw of the test item
- No. of animals per sex per dose:
- 13 to 15 females/group
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 0.25 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects. Remark: Embryolethality
Effect levels (fetuses)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- >= 0.25 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Reduced body weight gain in dams at the two higher dose levels. Marked treatment-related embryotoxicity at all dose levels. Embryolethality of 50% at 0.25 mg/kg bw, increasing up to 100% at high dose. no teratogenic effects.
Applicant's summary and conclusion
- Conclusions:
- no teratogenicity effects on fetuses were observed.
Dermal application of an ointment containing 0.5 % fluocortolone was done at doses of 0.25, 2.5 or 12.5 mg/kg bw fluocortolone to the clipped and scarified skin of rabbits (13 to 15 females/group) once daily on the gestation days 6 -18. Maternal toxicity was observed as reduced body weight gain at the two higher dose levels. The NOAEL for maternal toxicity was determined at 0.25 mg/kg bw. A marked treatment-related embryotoxicity was seen at all dose levels. Even the lowest dose level led to an embryolethality of 50% which increased with increasing dose up to 100%. Teratogenic effects were not observed. - Executive summary:
In a developmental toxicity study conducted similar to OECD test guideline 414 but prior to implementation of OECD guidelines Fluocortolone (0.5% a.i. in ointment) was administered dermally to 13 to 15 female New Zealand White rabbits/dose at dose levels of 0, 50, 500, or 2500 mg ointment/kg bw/day corresponding to 0, 0.25, 2.5 and 12.5 mg test item/kg bw/day from days 6 through 18 of gestation.
In does a reduced body weight gain was observed at the two higher dose levels. A marked treatment-related embryotoxicity was noted at all dose levels. Embryolethality of 50% occurred at 0.25 mg/kg bw, increasing up to 100% at high dose. Teratogenic effects were not observed. The maternal NOAEL is> 0.25 mg/kg bw/day, based on reduced body weight gain in does. The developmental LOAEL is> 0.25 mg/kg bw/day, based on embryolethality.
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