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EC number: 941-489-9 | CAS number: -
- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Remarks:
- in vitro
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- other: Protocol Draft
- Title:
- Draft Updated ICCVAM Recommended HET-CAM Protocol
- Author:
- ICCVAM
- Year:
- 2 010
- Bibliographic source:
- ICCVAM Test Method Evaluation Report: Current Validation Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard Potential of Chemicals and Products - NIH Publication No. 10-7513
- Report date:
- 2010
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- ANNEX - A Sequential Testing Strategy for Eye Irritation and Corrosion .
- Qualifier:
- according to guideline
- Guideline:
- other: Draft Updated ICCVAM Recommended HET-CAM Protocol.
- Principles of method if other than guideline:
- Results from in vitro or ex vivo tests: Substances that have demonstrated corrosive or severe irritant properties in an in vitro or ex vivo test that has been validated and accepted for the assessment specifically of eye or skin corrosivity/irritation, need not be tested in animals. It can be presumed that such substances will produce similar severe effects in vivo.
Even if HET-CAM assay heve not achieved the OECD validation, it is accepted for the purpose of "TESTING AND EVALUATION STRATEGY FOR EYE IRRITATION/CORROSION" as reported in ANNEX of test method B.5. - 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
- 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
- Physical state: chrystalline white powder
- Analytical purity: 99.8 %
- Lot/batch No.: 1153320/MP36894
- Expiration date of the lot/batch: 21/10/2012
- Storage condition of test material: at room temperature, protected fron light
Constituent 1
Test system
- Vehicle:
- physiological saline
- Remarks:
- B. Braun Melsungen, lot n. 017A122, expiry date: 03/2013.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Prednisolone 100 % applied to an area of 25 % of the chorioallantoic membrane.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 mL of standard solution (0.9 % NaCl)
- Lot/batch no. 017A122 - Duration of treatment / exposure:
- The reaction on the CAM were observed over a period of 5 minuted monitoring the appearance of:
Haemorrhage (bleeding);
Vascular lysis (blood vessel disintegration);
Coagulation (protein denaturation intra- and extravascular). - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: Prednisolone was left in contact with the egg membrane for 5 minutes.
SCORING SYSTEM: the time for each reaction to occur was recorded and an irritation score (IS) was calculated:
IS = [(301-sec H)/300] x 5 x S+ [(301-sec L)/300] x 7 x S + [(301-sec C)/300] x 9 x S
sec = second of first occurence of reaction
H = Haemorrhage
L = Vascular Lysis
C = Coagulation
S = 0.1 if H, C, L is grade 1 (weak reaction)
S = 0.5 if H, C, L is grade 2 (moderate reaction)
S = 1 if H, C, L is grade 3 (strong reaction)
The mean score was calculated from irritation scores for each egg for each test group.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Not relevant
- Score:
- 0
- Max. score:
- 21
- Remarks on result:
- other: Prednisolone was classified as non-irritant.
Any other information on results incl. tables
The eye irritancy potential of the test item was investigated in the chorioallantoic membrane assay.
The test item was tested as provided by the sponsor in order to find any irritancy potential.
The calculated mean irritation score was 0.
The test item was classified as non-irritant.
The positive and negative controls were within the historical control data range demonstrating the validity and sensitivity of the test.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Read-across approach
- Conclusions:
- On the basis of the read-across results, interpreted according to ICCVAM Recommended HET-CAM Protocol, because the test product "PREDNISOLONE" is considered NOT IRRITANT for the eye, also the structurally related compound 9β,11β-epoxy-6α-fluoro-17,21-dihydroxypregna-1,4-diene-3,20-dione 21-acetate should be considered as NOT IRRITANT.
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