Registration Dossier
Registration Dossier
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EC number: 607-277-2 | CAS number: 23825-05-0
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2010
Materials and methods
Test guideline
- 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 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
- Substance type: organic
- Physical state: solid
Constituent 1
In vitro test system
- Test system:
- artificial membrane barrier model
- Vehicle:
- unchanged (no vehicle)
- Amount/concentration applied:
- 500 mg
Results and discussion
In vitro
Resultsopen allclose all
- 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
Any other information on results incl. tables
| 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.
Applicant's summary and conclusion
- 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.
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