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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: 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:
other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
OECD Guideline for the testing of chemicals N. 439 - In vitro skin irritation: Reconstructed Human Epidermis test method.
Author:
OECD
Year:
2010
Bibliographic source:
http://www.oecd.org/env/testguidelines
Report Date:
2010
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 439
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
- Physical state: solid
- Analytical purity: 99.8%
- Purity test date: 16/07/2010
- Lot/batch No.: 1153320/MP36894
- Expiration date of the lot/batch: June 2012

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other:
Value:
60.96
Remarks on result:
other:
Remarks:
Basis: mean of the nine experiments.. Max. score: 100.0. (migrated information)

Any other information on results incl. tables

Optic density (OD) at 570 nm

 REPLICA  1  2  3  4  5  6  7  8  9
 Blank 0.090   0.089  0.092  0.093  0.090  0.090  -  -  -
 Negative control  1.273  1.407  1.422  1.451  1.445  1.440  1.412  1.416  1.418
 Positive control  0.130  0.143  0.142  0.140  0.141  0.143  0.139  0.141  0.146
 Prednisolone  0.780  0.910  0.905  0.946  0.915  0.914  0.907  0.901  0.884

   Average OD  Acceptability  Result  SD %  Acceptability (%)  Result
 Negative control  1.32  1.2 ≤ OD ≤ 2.5  Complying  3.762  ≤ 18  Complying
 Positive control  3.74  < 40 %  Complying  2.837  ≤ 18  Complying

 SAMPLE  % VIABILITY  ACCEPTABILITY
 PREDNISOLONE  60.96  > 50 %

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
On the basis of the results, interpreted according to OECD 439 and SKINETHIC SOP (January 2009), the test product "PREDNISOLONE" must be considered NOT IRRITANT for the skin.