Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 200-021-7 | CAS number: 50-24-8
Acute Toxicity: oral
Administrative data
- 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.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
- Reference Type:
- secondary source
- Title:
- TU4152000
- Author:
- Canadian Center for Occupational Health and Safety.
- Year:
- 2 010
- Bibliographic source:
- RTECS - Registry of toxic Effects of Chemical Substances.
Materials and methods
- Principles of method if other than guideline:
- No data.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Prednisolone
- EC Number:
- 200-021-7
- EC Name:
- Prednisolone
- Cas Number:
- 50-24-8
- Molecular formula:
- C21H28O5
- 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: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Control animals:
- not specified
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 857 mg/kg bw
- Based on:
- test mat.
- 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.
Any other information on results incl. tables
TOXIC EFFECT:
- Behavioral: somnolence (general depressed activity).
- Blood: hemorrhage.
- Nutritional and Gross Metabolic: weight loss or decreased weight gain.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 reported in male and female rats is higher than 2000 mg/kg bw. Thus, prednisolone was not considered an acute toxicant.
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.
