Registration Dossier
Registration Dossier
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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
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EC number: 201-476-4 | CAS number: 83-43-2
- 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: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Methylprednisolone, Summary Report
- Author:
- The European Agency for the Evaluation of Medicinal Products, Committee for Veterinary Medicinal Products
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Limit test:
- no
Test material
- Reference substance name:
- 86401-95-8
- Cas Number:
- 86401-95-8
- IUPAC Name:
- 86401-95-8
- Reference substance name:
- Methylprednisolone aceponate
- IUPAC Name:
- Methylprednisolone aceponate
- Reference substance name:
- 11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione, 21-acetate 17-propionate
- IUPAC Name:
- 11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione, 21-acetate 17-propionate
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- subcutaneous
- Duration of treatment / exposure:
- 14-week
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.4, 4, 40 and 400 μg/kg bw/day
- Control animals:
- yes
Results and discussion
Results of examinations
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Details on results:
- Body weight gain and food consumption were reduced in males given 40 μg/kg bw and above and females given 400 μg/kg bw and above. Leucocyte counts were reduced in both sexes given 400 μg/kg bw and bone marrow lymphocytes were reduced in males given 400 μg/kg bw and females given 4 μg/kg bw and above. Changes in serum clinical chemistry values at 400 μg/kg were indicative of effects on the liver and kidney. Atrophy of the thymus and adrenal glands was observed in the 400 μg/kg bw group at necropsy.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 0 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL was 0.4 μg/kg bw/day, and the target organs were blood forming organs and adrenal gland.
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.
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