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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP-compliant guideline study, available as unpublished report, fully adequate for assessment.The restriction is due to the use of the read across approach: the test was performed not with hydroxyprednisolone but with prednisolone, a substance which is very similar in structure and physical/chemical properties.

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
Guideline:
other: OECD 439
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: Optic density (OD) at 570 nm.
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.
Executive summary:

This in vitro skin irritation test was performed with prednisolone, a compound which has been demonstrated to be very similar in structure, physicochemical properties and toxicological profile to hydroxyprednisolone in the Analogue Approach - Read across Hydroxyprednisolone document (2013, see section 13). Due to the fact hydroxyprednisolone and prednisolone have nearly the same chemical structure, the same interaction with bio-molecules, living cells and tissue and metabolic pathway is expected. Therefore, a read across from hydroxyprednisolone to data obtained with prednisolone is scientifically justified.