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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
2006
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Prednisolone
- Substance type: organic
- Physical state: solid

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.