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EC number: 206-825-4 | CAS number: 378-44-9
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979/1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline study, some restrictions in design and/or reporting but otherwise adequate for assessment of the betamethasone mother/fetus transfer.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
- Type of study / information:
- The plasma concentrations of betamethasone in a maternal peripheral vein (mv) and in the umbilical vein (uv) were measured at delivery in eleven patients after the administration of betamethasone phosphate equivalent to 8 mg betamethasone. Betamethasone concentrations were measured in plasma using a specific and sensitive HPLC assay.
After equilibration across the placenta has occurred, the plasma concentration of betamethasone in the umbilical vein will be approximately 25 to 30% of the concomitant maternal level.
- Principles of method if other than guideline:
- Examination of the betamethasone concentration on blood of eleven women, aged 27 to 37 years with estimated gestational ages ranging from 31 to 38 weeks, were carried out, after obtaining informed consent from the mother, on samples drawn from a maternal peripheral vein at delivery, and from the umbilical vein of the clamped cord after delivery of the placenta. To all of the women, betamethasone had been prescribed for antenatal administration. Betamethasone was administered as its phosphate ester, equivalent to 8 mg of betamethasone free alcholol, in one or two doses.
The interval from the time of the last dose to the time of delivery varied from 56 to 800 min.
HPLC determination was perrormed with prednisolone as internal standard. The retention time of betamethasone was 6.1 min while prednisolone retention time was 10.3 min. Betamethasone phosphate is not extracted from the biological matrix during the assay procedure and therefore does not interfere with the chromatography of betamethasone.
The specificity of the HPLC assay was also examined by detection at 240 nm and 254 nm, using two ultraviolet detectors connected in series.
The ratio of the absorbance of the chromatographic peak with a retention time of 6.1 rain at 240 nm to that at 254 nm was calculated and compared to the ratio observed when an authentic standard of betamethasone was injected directly into the chromatograph. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Betamethasone phosphate
- IUPAC Name:
- Betamethasone phosphate
- Reference substance name:
- Betamethasone
- EC Number:
- 206-825-4
- EC Name:
- Betamethasone
- Cas Number:
- 378-44-9
- Molecular formula:
- C22H29FO5
- IUPAC Name:
- 9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
- Details on test material:
- - Name of test material (as cited in study report): Betamethasone phosphate
- Molecular formula (if other than submission substance): C22H28FNa2O8P
- Molecular weight (if other than submission substance): 516.404624 [g/mol]
- Smiles notation (if other than submission substance): CC1CC2C3CCC4=CC(=O)C=CC4(C3(C(CC2(C1(C(=O)COP(=O)([O-])[O-])O)C)O)F)C.[Na+].[Na+]
- InChl (if other than submission substance): InChI=1S/C22H30FO8P.2Na/c1-12-8-16-15-5-4-13-9-14(24)6-7-19(13,2)21(15,23)17(25)10-20(16,3)22(12,27)18(26)11-31-32(28,29)30;;/h6-7,9,12,15-17,25,27H,4-5,8,10-11H2,1-3H3,(H2,28,29,30);;/q;2*+1/p-2/t12-,15-,16-,17-,19-,20-,21-,22-;;/m0../s1
- Structural formula attached as image file (if other than submission substance): see Fig.
Constituent 1
Constituent 2
Results and discussion
Any other information on results incl. tables
Placental transfer characteristics of betamethasone
Patient | Route of administration | D-Da min | Cmv ng/ml | Cuv ng/ml | Cuv/Cmv |
1 | IV | 56 | 83.9 | 22.9 | 0.27 |
2 | IV | 61 | 65.0 | 16.8 | 0.26 |
3 | IM | 116 | 29.8 | 7.7 | 0.26 |
4 | IM | 121 | 36.0 | 9.8 | 0.27 |
5 | IM | 137 | 67.2 | 19.8 | 0.29 |
6 | IM | 259 | 37.8 | 8.6 | 0.23 |
7 | IM | 321 | 34.7 | 12.7 | 0.37 |
8 | IM | 331 | 31.6 | 9.4 | 0.30 |
9 | IM | 377 | 43.4 | 13.8 | 0.32 |
10 | IM | 381 | 33.3 | 9.6 | 0.29 |
11 | IV | 800 | 15.2 | 3.6 | 0.24 |
a Interval between the last dose and delivery
Cmv: Concentration on maternal vein
Cuv: Concentration umbilical vein
Applicant's summary and conclusion
- Conclusions:
- Betamethasone crosses placenta and it was detectable as unmetabolized free alcohol in approximately 25 to 30% of the concomitant maternal level.
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