Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the results of studies with structural analogues 16alpha-hydroxyprednisolone and prednisolone, Prediac-Z is not mutagenic in Ames test, both with and without metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 March 2013 to 3 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 5, 15, 50, 150, 500, 1500 and 5000 µg/plate of hydroxyprednisolone he tests on S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: hydroxyprednisolone was insoluble in water but soluble in DMSO - Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- Two independent mutation tests were performed in the presence and absence of liver preparations (S9 mix) from rats treated with phenobarbital and 5,6-benzoflavone. The first test was a standard plate incorporation assay; the second included a pre-incubation stage.
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- It was concluded that 16alpha-hydroxyprednisolone showed no evidence of mutagenic activity in this bacterial system at doses up to 5000 micrograms/plate under the test conditions employed.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study is classified as reliable with restrictions because, although it is not-GLP compliant, it is an acceptable and a well-documented study report, according or similar to a guideline, that meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- Were used only two of the five bacterial strains recommended from the guideline.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Were used only two of the five bacterial strains recommended from the guideline.
- Principles of method if other than guideline:
- The test chemical in 0.1 ml dimethyl sulfoxide or H20 was placed in a tube and mixed with 0.5 ml S-9 mix (150 microliter of the S-9 fraction of rat liver pretreated with polychlorinated biphenyl, 2 micromol NADPH, 2 micromol NADH, 2.5 micromol glucose 6-phosphate, 0.25 unit glucose-6-phosphate dehydrogenase, 4 micromol MgCI2, 16.5 micromol KCI, and 50 micromol sodium phosphate buffer, pH 7.4 and 0.1 ml of culture of the bacterial tester strain (1 to 2 x 10E8 cells). Without metabolic activation 50 micromol sodium phosphate buffer, pH 7.4, in 0.5 ml were used instead of S-9 mix. The mixture was preincubated at 37° for 20 min and then mixed with 2 ml top agar (0.7% agar and 0.6% NaCI) at 45° and spread on a minimal glucose agar plate containing 0.1 micromol each L-histidine and biotin. Plates were incubated at 37° for 2 days, and then his+ revertant colonies were counted.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: This strain carryies R-factor plasmid pKM101.
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: This strain carryies R-factor plasmid pKM101.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- Prednisolone was tested at 8.3, 17, and 33 micrograms/plate. Drug contained some vehicle, and the amount of the drug was expressed as micrograms of active principle.
- Untreated negative controls:
- yes
- Remarks:
- Average of values in 20 experiments.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Vehicle controls.
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Also daunomycin hydrochloride, and adriamycin hydrochloride were reported as positive controls.
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Prednisolone was not lethal at doses of up to 33 micrograms/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Prednisolone was not lethal at doses of up to 33 micrograms/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- Prednisolone was not mutagenic to in S. typhimurium TA98 and TA100 strains with or without S-9 mix, and it was not cytotoxic at doses of up to 33 micrograms/plate.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 20 March 2013 to 3 April 2013
- 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 471 (Bacterial Reverse Mutation Assay)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- In a reliable guideline study concluded with a structural analogue 16alpha-hydroxyprednisolone no evidence of mutagenic activity iat doses up to and including 5000 micrograms/plate were seen in S. typhimurium strains TA98, TA100, TA153 and TA1535 and E. coli strain WP2 uvrA, both with and without metabolic activation. This result can be read across to Prediac-Z.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting 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:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- Were used only two of the five bacterial strains recommended from the guideline.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Were used only two of the five bacterial strains recommended from the guideline.
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Prednisolone was not lethal at doses of up to 33 micrograms/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Prednisolone was not lethal at doses of up to 33 micrograms/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- In a comparable to guideline study with a structural analogue of Prediac-Z, prednisolone, the test substance was not mutagenic to S. typhimurium strains TA98 and TA100 with or without S-9 mix, and was not cytotoxic at doses of up to 33 micrograms/plate. This result can be read across to Prediac-Z.
Referenceopen allclose all
his+revertants/plate | |||||||||
TA100 | TA98 | ||||||||
micrograms/plate | + S-9 mix | - S-9 mix | + S-9 mix | - S-9 mix | his+revertants/nmola | ||||
Prednisoloneb | 8.3 | 135 | 125 | 37 | 34 | 0 | |||
17 | 145 | 145 | 39 | 33 | |||||
33 | 123 | 144 | 35 | 23 | |||||
Controlc | 147 | 132 | 30 | 16 |
aThe number ofhis+revertants per nmol was calculated from the data obtained under the most active conditions in
the linear dose-responsible range and a yield of 100 colonies more than the background yield.
bDrug contained some vehicle, and the amount of the drug was expressed as micrograms of active principle.
cAverage of values in 20 experiments.
his+revertants/plate | |||||||||
TA100 | TA98 | ||||||||
micrograms/plate | + S-9 mix | - S-9 mix | + S-9 mix | - S-9 mix | his+revertants/nmola | ||||
Prednisoloneb | 8.3 | 135 | 125 | 37 | 34 | 0 | |||
17 | 145 | 145 | 39 | 33 | |||||
33 | 123 | 144 | 35 | 23 | |||||
Controlc | 147 | 132 | 30 | 16 |
aThe number ofhis+revertants per nmol was calculated from the data obtained under the most active conditions in
the linear dose-responsible range and a yield of 100 colonies more than the background yield.
bDrug contained some vehicle, and the amount of the drug was expressed as micrograms of active principle.
cAverage of values in 20 experiments.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In a reliable GLP-compliant guideline study a stuctural analogue 16alpha-hydroxyprednisolone was found to be not mutagenic in Ames test in S. typhimurium strains TA98, TA100, TA1535 and TA1537 and E. coli strain WP2 uvrA, when tested up to limit concentrations, both with and without metabolic activation.
In a study with a structural analogue prednisolone, in which only two S. typhimurium strains were tested (TA98 and TA100), prednisolone was not mutagenic when tested up to precipitating concentrations, both with and without metabolic activation.
Based on these results Prediac-Z is considered not mutagenic in the Ames test.
Justification for classification or non-classification
Based on the negative results of the Ames tests conducted with structural analogues 16alpha-hydroxyprednisolone and prednisolone, classification of Prediac-Z for genotoxicity is not warranted under Regulation (EC) 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.