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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 oral acute toxicity studies with two structural analogues prednisolone and 16alpha-hydroxyprednisolone, Prediac-Z is considered not acutely toxic by oral route (LD50 > 2000 mg/kg bw).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study is reported on RTECS database. The use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation. Therefore, although the method is unknown, the values presented here are acceptable as they are from a reliable secondary source of biological data.
- Principles of method if other than guideline:
- No data.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 857 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 879 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The animals died on the 3rd and 7th day.
- Clinical signs:
- other: In a clinical presentation of acute intoxication signs of adrenal insufficiency were observed: lethargy, slovenliness of animals` coat, bloody issues from a nasopharynx.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 reported in male and female rats is higher than 2000 mg/kg bw. Thus, prednisolone was not considered an acute toxicant.
- Endpoint:
- acute toxicity: oral
- 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
- Principles of method if other than guideline:
- No data.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 857 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 879 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The animals died on the 3rd and 7th day.
- Clinical signs:
- other: In a clinical presentation of acute intoxication signs of adrenal insufficiency were observed: lethargy, slovenliness of animals` coat, bloody issues from a nasopharynx.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study conducted with a structural analogue of Prediac-Z, prednisolone, the LD50 reported in male and female rats was higher than 2000 mg/kg bw. Thus, prednisolone was not considered an acute toxicant. This result can be read across to Prediac-Z.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Storage conditions: room temperature in the dark
- Species:
- rat
- Strain:
- other: Hsd (SD) albino rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: well known breeder
- Age at study initiation: approximately eight to twelve weeks of age prior to dosing (Day 1)
- Weight at study initiation: 165 to 175 g
- Fasting period before study: overnight prior to and approximately four hours after dosing
- Housing: in groups of up to three rats, in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved
wood flake bark-free fibre bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours continuous dark
IN-LIFE DATES: From: 8 April 2013 To: 28 May 2013 - Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/v aqueous methyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 1% w/v aqueous methyl cellulose
MAXIMUM DOSE VOLUME APPLIED:10 mL/kg bodyweight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose levels for the study were chosen in compliance with the study guidelines. As no previous toxicological information was available, the initial dose level was 300 mg/kg. - Doses:
- 300 and 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 6 female rats dosed with 300 mg/kg bw
6 female rats dosed with 1000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only).The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Macroscopic pathology: All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study
- Clinical signs:
- other: There were no signs of ill health, behavioural change or reaction to treatment observed throughout the study.
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of 16alpha-hydroxyprednisolone was demonstrated to be greater than 2000 mg/kg bodyweight.
- Endpoint:
- acute toxicity: oral
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Control animals:
- no
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study
- Clinical signs:
- other: There were no signs of ill health, behavioural change or reaction to treatment observed throughout the study.
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study conducted with a structural analogue of Prediac-Z, 16alpha-hydroxyprednisolone, the acute median lethal oral dose (LD50) to rats was > 2000 mg/kg bodyweight. This result can be read across to Prediac-Z.
Referenceopen allclose all
TOXIC EFFECT:
- Behavioral: somnolence (general depressed activity).
- Blood: hemorrhage.
- Nutritional and Gross Metabolic: weight loss or decreased weight gain.
TOXIC EFFECT:
- Behavioral: somnolence (general depressed activity).
- Blood: hemorrhage.
- Nutritional and Gross Metabolic: weight loss or decreased weight gain.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 2 (read-across from a structural analogue)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a reliable GLP-compliant OECD guideline 423 study with a structural analogue 16alpha-hydroxyprednisolone, an oral LD50 in rats was > 2000 mg/kg bw. This result is consistent with the results of the study with another structural analogue prednisolone, in which the LD50 > 3000 mg/kg bw was reported. Based on the read-across from two structural analogues, Prediac-Z is considered to be not acutely toxic by oral route (LD50 > 2000 mg/kg bw).
Justification for classification or non-classification
Based on the acute oral LD50 > 2000 mg/kg bw, obtained in the studies with structural analogues prednisolone and 16alpha-hydroxyprednisolone, Prediac-Z does not need to be classify for acute toxicity in accordance with Regulation (EC) 1272/2008.
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