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Diss Factsheets
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EC number: 276-705-4 | CAS number: 72498-89-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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 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 from light.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, 33178 Bochen, Germany
- Strain: CBA/CaOlaHsd mice
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 18-22 g
- Housing: Full barrier in an air-conditioning room. The animals were kept in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding.
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1315)
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH of approx. 2.8
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10 x
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- The preparations were made immediately prior to each use.
- Concentration:
- The maximum technically applicable concentration of prednisolone was found to be 25 % in AOO (Acetone/Olive Oil 4:1). Thus, a preliminary test was assessed for sensitising properties at concentrations of 6.25 %, 12.5%, and 25% (w/v).
- No. of animals per dose:
- 5 mice per test group (6.25 %, 12.5 %, 25 %, and negative control group).
Moreover 5 animals were used for the positive control assay with p-phenilenediamine. - Positive control substance(s):
- other: p-Phenylenediamine (CAS 106-50-3, Sigma, purity > 98%; lot n. 069K0076) 1%, applied on three consecutive days.
Results and discussion
- Positive control results:
- Application of p-Phenilenediamine gave a stimulation index ranging from 6.1 to 11.2 with a median value of 8.6. A substance is regarded as sensitiser in the LLNA with a Stimulation Index equal to or greater than 3.0.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index at a concentration of 6.25 % was 0.03 The stimulation index at a concentration of 12.5 % was 0.08 The stimulation index at a concentration of 25 % was 0.03
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- The DPM median value at a concentration of 6.25 % was 48.0 (± 22.4) The DPM median value at a concentration of 12.5 % was 114.8 (± 38.9) The DPM median value at a concentration of 25 % was 57.6 (± 37.1) The DPM median value of the Negative Control was 1335.4 (± 217.3) The DPM median value of the Positive Control was 10255.0 (± 2101.7)
Any other information on results incl. tables
Test Item | CPM | Conc. % | Animal number | DPM | Stimulation Index |
Prednisolone | 17.0 | 6.25 | 1 | 35.0 | 0.02 |
Prednisolone | 43.0 | 6.25 | 2 | 86.0 | 0.05 |
Prednisolone | 14.0 | 6.25 | 3 | 29.0 | 0.01 |
Prednisolone | 21.0 | 6.25 | 4 | 42.0 | 0.02 |
Prednisolone | 137.0* | 6.25 | 5 | 334.0* | n.d. |
Prednisolone | 67.0 | 12.5 | 6 | 134.0 | 0.09 |
Prednisolone | 45.0 | 12.5 | 7 | 89.0 | 0.06 |
Prednisolone | 60.0 | 12.5 | 8 | 119.0 | 0.08 |
Prednisolone | 86.0 | 12.5 | 9 | 173.0 | 0.12 |
Prednisolone | 30.0 | 12.5 | 10 | 59.0 | 0.03 |
Prednisolone | 51.0 | 25 | 11 | 103.0 | 0.07 |
Prednisolone | 50.0 | 25 | 12 | 100.0 | 0.07 |
Prednisolone | 10.0 | 25 | 13 | 20.0 | 0.00 |
Prednisolone | 23.0 | 25 | 14 | 46.0 | 0.02 |
Prednisolone | 10.0 | 25 | 15 | 19.0 | 0.00 |
Negative Control | 670.0 | 16 | 1345.0 | ||
Negative Control | 852.0 | 17 | 1719.0 | ||
Negative Control | 626.0 | 18 | 1263.0 | ||
Negative Control | 519.0 | 19 | 1048.0 | ||
Negative Control | 647.0 | 20 | 1302.0 | ||
p-Phenylenediamine | 3512.0 | 1 | 21 | 7308.0 | 6.1 |
p-Phenylenediamine | 4258.0 | 1 | 22 | 8937.0 | 7.5 |
p-Phenylenediamine | 4811.0 | 1 | 23 | 9939.0 | 8.4 |
p-Phenylenediamine | 6376.0 | 1 | 24 | 13277.0 | 11.2 |
p-Phenylenediamine | 5650.0 | 1 | 25 | 11814.0 | 9.9 |
CPM: counts per minute; Conc.: Concentration; DPM: disintegration per minute.
* = outlier, failed Grubbs, Nalimov, and Dixon; n.d.: not determined.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Read-across approach
- Conclusions:
- Because of, according to OECD 429 and the criteria given in Annex I of Regulation (EC) 1272/2008, the test item Prednisolone, as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser, the substance 9β,11β-epoxy-6α-fluoro-17,21-dihydroxypregna-1,4-diene-3,20-dione 17,21-di(acetate) should be considered as NOT SENSITISER.
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