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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 218-370-9 | CAS number: 2135-17-3
- 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:
- key study
- Study period:
- From 3 Feb to 17 June 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted to an OECD guideline or to GLP. However, the study is well described and documented.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of corticoid administration on bovine pregnancy
- Author:
- James W. Lauderdale, Ph.D.
- Year:
- 1 972
- Bibliographic source:
- Journal of American Veterinary Medical Association V.160,No. 6
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The substance is administered intramuscularly to pregnant cows for 3 consecutive days. The dosing time is set at predetermined stages of gestation. The study looks into effect of administration on the pregnant cow and the timing/viability of pregnancy and offspring.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Flumetasone
- EC Number:
- 218-370-9
- EC Name:
- Flumetasone
- Cas Number:
- 2135-17-3
- Molecular formula:
- C22H28F2O5
- IUPAC Name:
- (1R,2R,3aS,3bS,5S,9aS,9bR,10S,11aS)-5,9b-difluoro-1,10-dihydroxy-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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch No.: Not specified
Purity: Not specified
Constituent 1
Test animals
- Species:
- other: bovine
- Strain:
- other: Hereford, Aberdeen Angus and Hereford-Aberdeen Angus
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3 to 7 years of age
No additional data
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- water
- Details on exposure:
- None stated
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Proof of pregnancy: confirmation of pregnancy by rectal palpation
No additional data - Duration of treatment / exposure:
- Once per day 3 days starting on Days 185, 215, 245 and 268 of gestation
- Frequency of treatment:
- Once per day
- Duration of test:
- None stated
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5 mg/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 16 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- None stated
Examinations
- Maternal examinations:
- The uterus of each cow was palpated per rectum prior to initiation of each series of injections and on day 7 after the start of each series of injections. Observations of cows for calving were made at least once a day and usually 2 to 3 times each day.
- Ovaries and uterine content:
- None stated
- Fetal examinations:
- After calving, cows were observed for signs of retained placenta and metritis.
- Statistics:
- Squares analysis in combination with a Dunnett's t test.
- Indices:
- None stated
- Historical control data:
- None stated
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Gestation length was shortened significantly by the test substance when injections were started on day 268 of gestation. Variation in interval between injection and calving was reduced by the test substance. Maximum gestation length for cows treated with the test substance (273 days) was less than minimum gestation length (275 days) for cows treated with water.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Retained placenta was observed in all cows treated with the test substance. Use of the corticoid at day 268 of gestation did not affect calf viability, also did not affect the mean intervals between calving to pregnancy and percentage of cows pregnant. All calves aborted by cows treated with the test substance at Day 215 of gestation died.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The data support the hypothesis that administration of the test substance (via intramuscular route of administration) induces abortion and parturition in cows. The data do not indicate an effect on fertility.
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.