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EC number: 607-277-2 | CAS number: 23825-05-0
- 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
Endpoint summary
Administrative data
Description of key information
Based on the results of two reliable in vitro studies conducted with a structural analogue prednisolone, Prediac-Z is considered not irritating and not corrosive to skin.
Based on the results of a reliable chorioallantoic membrane assay conducted with a structural analogue prednisolone, Prediac-Z is considered not irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- 2006
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- artificial membrane barrier model
- Vehicle:
- unchanged (no vehicle)
- Amount/concentration applied:
- 500 mg
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 1
- Value:
- > 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 2
- Value:
- > 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 3
- Value:
- > 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 4
- Value:
- > 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance "PREDNISOLONE", assigned to Category 2 (weak acids and bases), did not cause corrosion of the biobarrier in time to the classification according to UN Packing Trasportation Group. On the basis of the results, interpreted according to OECD N° 435 of July 19, 2006, the test substance "PREDNISOLONE" is classified as NOT CORROSIVE.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Skinethic RHE is a 3D system of reconstructed epidermis of normal human keratinocytes.
Cells are grown on inert polycarbonate filter on chemically defined medium, airlifted for 17 days. The model exhibits normal barrier functions (presence of a differentiated stratum corneum).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
NUMBER OF REPLICATE TISSUES: triplicate
PREDICTION MODEL / DECISION CRITERIA:
The test substance is considered to be irritant to skin, if the mean relative viability after 42 minutes exposure and 42 hours post incubation is less or equal to 50 % of the negative control.
ACCEPTABILITY CRITERIA
The negative control data meet the acceptance criteria if the mean OD value of the 3 tissues at 570 nm is: 1.2 ≤ OD ≤ 2.5 The positive control data meet the acceptance criteria if the mean viability, expressed as % of the NC, is ≤ 40 %. In both cases, the standard deviation value will be considered valid if it is ≤ 18 % according to the performance standard (ECVAM SIVS, 2007). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 42 minutes
- Number of replicates:
- Triplicate
- Irritation / corrosion parameter:
- other: other: Optic density (OD) at 570 nm.
- Run / experiment:
- 1-9 (mean of 9 experiments)
- Value:
- 60.96
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- not irritating
- Remarks:
- 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.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read-across from a structural analogue
- Justification for type of information:
- The read-across rationale is attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- 2006
- Deviations:
- no
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 1
- Value:
- > 60
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 2
- Value:
- > 60
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 3
- Value:
- > 60
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 4
- Value:
- > 60
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a reliable study with a structural analogue of Prediac-Z, prednisolone, the test substance prednisolone did not cause corrosion of the biobarrier within 60 minutes. On the basis of the results, interpreted according to OECD N° 435 of July 19, 2006, the test substance prednisolone is considered not corrosive. This result can be read across to Prediac-Z.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read-across from a structural analogue
- Justification for type of information:
- The read-across rationale is attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2010
- Deviations:
- no
- Irritation / corrosion parameter:
- other: other: Optic density (OD) at 570 nm.
- Run / experiment:
- 1-9 (mean of 9 experiments)
- Value:
- 60.96
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- On the basis of the results of a reliable guideline study conducted with a structural analogue of Prediac-Z, prednisolone, the test substance must be considered not irritating to skin. This result can be read across to Prediac-Z.
Referenceopen allclose all
Replicate | Started at ti (hh:mm:ss) | Ended at tf (hh:mm:ss) | Corrosion time (hh:mm:ss) | Mean corrosion time (hh:mm:ss) | RESULT | |
Prednisolone | 1 | 11:23:26 | End test* | > 60 minutes | > 60 minutes | Not Corrosive |
2 | 11:25:01 | End test* | > 60 minutes | |||
3 | 11:26:13 | End test* | > 60 minutes | |||
4 | 11:27:36 | End test* | > 60 minutes | |||
Negative Control | 1 | 11:29:33 | 12:36:24 | 1:06:51 | > 60 minutes | Not Corrosive |
Positive Control | 1 | 11:33:27 | 11:34:42 | 0:01:51 | 0:01:51 | Corrosive |
* The End time of testing is equivalent to that of negative control.
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 % |
Replicate | Started at ti (hh:mm:ss) | Ended at tf (hh:mm:ss) | Corrosion time (hh:mm:ss) | Mean corrosion time (hh:mm:ss) | RESULT | |
Prednisolone | 1 | 11:23:26 | End test* | > 60 minutes | > 60 minutes | Not Corrosive |
2 | 11:25:01 | End test* | > 60 minutes | |||
3 | 11:26:13 | End test* | > 60 minutes | |||
4 | 11:27:36 | End test* | > 60 minutes | |||
Negative Control | 1 | 11:29:33 | 12:36:24 | 1:06:51 | > 60 minutes | Not Corrosive |
Positive Control | 1 | 11:33:27 | 11:34:42 | 0:01:51 | 0:01:51 | Corrosive |
* The End time of testing is equivalent to that of negative control.
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 % |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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 have 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)
- Vehicle:
- physiological saline
- Remarks:
- B. Braun Melsungen, lot n. 017A122, expiry date: 03/2013.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- 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 - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 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. - Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read-across from a structural analogue
- Justification for type of information:
- The read-across rationale is attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- 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. - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a reliable in vitro study conducted with a structural analogue of Prediac-Z, prednisolone, the test substance caused an average in vitro irritancy score of 0. Based on this, prednisolone is considered not an eye irritant. This result can be read across to Prediac-Z.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a reliable study performed according to OECD guideline 435 (July 19, 2006) with a structural analogue of Prediac-Z, prednisolone, the test substance prednisolone did not cause corrosion of the biobarrier within 60 minutes. On the basis of the results the test substance prednisolone is considered not corrosive. This result can be read across to Prediac-Z.
On the basis of the results of a reliable guideline study conducted according to OECD guideline 439 with a structural analogue of Prediac-Z, prednisolone, the substance is considered not irritating to skin.
In a reliable in vitro chorioallantoic membrane assay conducted with a structural analogue prednisolone, the test substance was not irritating to eye. The calculated mean in vitro irritancy score was 0. The positive and negative controls were within the historical control data range demonstrating the validity and sensitivity of the test.
Based on this, Prediac-Z is considered not irritating to eyes.
Justification for classification or non-classification
Based on the results of reliable in vitro studies conducted with a structural analogue prednisolone, classification of Prediac-Z for skin and eye irritation is not warranted according to Regulation (EC) 1272/2008.
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