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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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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.
Data source
Reference
- Reference Type:
- publication
- Title:
- Disproportionate growth of organs and body weight following glucocorticoid treatment of the rat fetus
- Author:
- Mosier, H.D. Jr; Dearden, L.C.; Jansons, R.A.; Roberts, R.C.; Biggs, C.S.
- Year:
- 1 982
- Bibliographic source:
- Dev. Pharmacol. Ther. 1982, 4, 89-105.
Materials and methods
- Principles of method if other than guideline:
- A mixture of betamethasone sodium phosphate and betamethasone acetate suspension (commercial dosage form) was administerd to Long-Evans rats during the first pregnancy, in a dose of 0.18 or 0.42 mg/injection, by subcutaneous injection on days 12 and 13 of gestation. All rats were weighed on day 12 of gestation prior to injections and again on day 21. Rats were sorted into experimental and control grups on the basis of body weight in order to provide similar means and variances of body weight between groups.
Control rats were injected with physiological saline.
Fetuses were removed on day 21 of gestatiojn under ether anesthesia, bled from the neck, weighed and examined for gross malformations. In fetuses used for organ weight determinations the abdiminal cavities were opened to enhance fixation and the fetuses were placed in 10% phosphate-buffered neutral formalin. Brain, heart, liver, adrenals, and kidneys were removed from the formalin-fixed fetuses, dissected free of surrounding tissues, blotted, and weighed on a semi-micro balance.
Statistical significance was determined by a one-tailed Student's t test or by calculation of the chi square statistic. - GLP compliance:
- not specified
- Type of method:
- in vivo
Test material
- Reference substance name:
- Betamethasone sodium phosphate
- IUPAC Name:
- Betamethasone sodium phosphate
- Reference substance name:
- Betamethasone acetate
- IUPAC Name:
- Betamethasone acetate
- Details on test material:
- - Name of test material (as cited in study report): mixture of betamethasone sodium phosphate and betamethasone acetate suspension
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Labs (Gilroy, California)
- Housing: Except during breeding, all animals were housed individually in stainless steel cages (hanging type) 7x7x10 inches in size
- Diet: ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23.9°C
- Photoperiod (hrs dark / hrs light): 10/14 hrs
- Animal handling was carried out by the same attendant
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- other: water; dibasic sodium phosphate; monobasic sodium phosphate; edetate disodium; and benzalkonium chloride.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 days, on day 12 and 13 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- From the day of appearance of vaginal plug, that was designed as day 1 of gestation, to day 21.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.18 mg/injection
Basis:
nominal conc.
corresponding to ca. 0.38 mg/kg bw at day 12 of pregnancy
- Remarks:
- Doses / Concentrations:
0.42 mg/injection
Basis:
nominal conc.
corresponding to ca. 0.89 mg/kg bw at day 12 of pregnancy
- No. of animals per sex per dose:
- 5 rats for 0.18 mg/injection
5 rats for 0.42 mg/injection - Control animals:
- other: yes, injected with physiological saline
- Statistics:
- Statistical significance was determined by a one-tailed Student's t test or by calculation of the chi square statistic.
Results and discussion
Any other information on results incl. tables
Control | Betamethasone 0.18 mg | Betamethasone 0.42 mg | |
RATS N. | 6 | 5 | 5 |
Weight (g) on day 12 | 283.7 ± 7.2 | 285.8 ± 8.3 | 289.2 ± 12.8 |
Weight (g) on day 21 | 369.2 ± 6.6 | 337.0 ± 10.4 (p<0.025) | 305.6 ± 17.6 (p<0.005) |
Litters, N. | 16 | 14 | 17 |
N. fetuses/litter | 10.19 ± 0.44 | 10.00 ± 0.47 | 9.82 ± 0.71 |
Incidence of cleft palate | 0/154 | n.a. | 3/47 (p<0.0017) |
Incidence of omphalocele | 0/348 | 8/127 (p<0.0001) | 13/140 (p<0.0001) |
Body weight, g (N. of fetuses) | 4.03 ± 0.04 (178) | 3.85 ± 0.05 (54) (p<0.01) | 2.75 ± 0.13 (36) (p<0.005) |
Brain weight, mg (N. of fetuses) | 203.3 ± 1.66 (178) | 216.9 ± 1.79 (53) (p<0.05) | 203.4 ± 0.66 (36) |
Heart weight, mg (N. of fetuses) | 24.73 ± 0.35 (177) | 23.50 ± 0.41 (54) (p<0.05) | 19.44 ± 0.66 (36) (p<0.005) |
Liver weight, mg (N. of fetuses) | 359.5 ± 3.48 (176) | 287.2 ± 5.69 (54) (p<0.005) | 157.6 ± 11.9 (35) (p<0.005) |
Adrenals weight, mg (N. of fetuses) | 2.31 ± 0.03 (172) | 2.09 ± 0.04 (54) (p<0.005) | 1.62 ± 0.07 (35) (p<0.005) |
Kidneys, mg (N. of fetuses) | 32.07 ± 0.42 (175) | 29.72 ± 0.66 (53) (p<0.005) | 19.09 ± 1.02 (36) (p<0.005) |
Applicant's summary and conclusion
- Conclusions:
- The marked differences in organ weight ratio with control, as well as organ weight / body weight ratio, suggest that betamethasone interfere with the proportionate growth controls in the fetus or the response of the organs to these controls. Marked differences that are relevant for this assessment are related not only to the fetal weight, but also to liver and kidneys weight in comparison with the control. Thus, it can be shown specific toxicity for these two organs.
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