11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione

Skin irritation / corrosion

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GLP-compliant guideline study, available as unpublished report, fully adequate for assessment.The restriction is due to the use of the read across approach: the test was performed not with hydroxyprednisolone but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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

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.