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Diss Factsheets
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EC number: 237-731-1 | CAS number: 13951-70-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-compliant guideline study, available as unpublished report, fully adequate for assessment.The restriction is due to the use of the read across approach: the test was performed not with hydroxyprednisolone but with prednisolone, a substance which is very similar in structure and physical/chemical properties.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- OECD Guideline for the testing of chemicals N. 439 - In vitro skin irritation: Reconstructed Human Epidermis test method.
- Author:
- OECD
- Year:
- 2 010
- Bibliographic source:
- http://www.oecd.org/env/testguidelines
- Report date:
- 2010
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 439
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Prednisolone
- EC Number:
- 200-021-7
- EC Name:
- Prednisolone
- Cas Number:
- 50-24-8
- Molecular formula:
- C21H28O5
- IUPAC Name:
- 11,17,21-trihydroxypregna-1,4-diene-3,20-dione
- Details on test material:
- - Name of test material (as cited in study report): Prednisolone
- Substance type: organic
- Physical state: solid
Constituent 1
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Optic density (OD) at 570 nm.
- Value:
- 60.96
- Remarks on result:
- other:
- Remarks:
- Basis: mean of the nine experiments.. Max. score: 100.0. (migrated information)
Any other information on results incl. tables
Optic density (OD) at 570 nm
REPLICA | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Blank | 0.090 | 0.089 | 0.092 | 0.093 | 0.090 | 0.090 | - | - | - |
Negative control | 1.273 | 1.407 | 1.422 | 1.451 | 1.445 | 1.440 | 1.412 | 1.416 | 1.418 |
Positive control | 0.130 | 0.143 | 0.142 | 0.140 | 0.141 | 0.143 | 0.139 | 0.141 | 0.146 |
Prednisolone | 0.780 | 0.910 | 0.905 | 0.946 | 0.915 | 0.914 | 0.907 | 0.901 | 0.884 |
Average OD | Acceptability | Result | SD % | Acceptability (%) | Result | |
Negative control | 1.32 | 1.2 ≤ OD ≤ 2.5 | Complying | 3.762 | ≤ 18 | Complying |
Positive control | 3.74 | < 40 % | Complying | 2.837 | ≤ 18 | Complying |
SAMPLE | % VIABILITY | ACCEPTABILITY |
PREDNISOLONE | 60.96 | > 50 % |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- On the basis of the results, interpreted according to OECD 439 and SKINETHIC SOP (January 2009), the test product "PREDNISOLONE" must be considered NOT IRRITANT for the skin.
- Executive summary:
This in vitro skin irritation test was performed with prednisolone, a compound which has been demonstrated to be very similar in structure, physicochemical properties and toxicological profile to hydroxyprednisolone in the Analogue Approach - Read across Hydroxyprednisolone document (2013, see section 13). Due to the fact hydroxyprednisolone and prednisolone have nearly the same chemical structure, the same interaction with bio-molecules, living cells and tissue and metabolic pathway is expected. Therefore, a read across from hydroxyprednisolone to data obtained with prednisolone is scientifically justified.
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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