17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Principles of method if other than guideline:

in vitro test

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate

EC Number:

223-768-0

EC Name:

17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate

Cas Number:

4062-46-8

Molecular formula:

C22H34O3

IUPAC Name:

1-methyl-3-oxoandrostan-17-yl acetate

Details on test material:

- Name of test material (as cited in study report): mesterolone acetate (ZK 5894)
- Purity test date: 100.6%
- Lot/batch No.: 94510001
- Expiration date of the lot/batch: Sep 2005

Test animals

Species:

other: SkinEthik-RHE/S/17: epidermis reconstituted by airlifted culture of normal human keratinocytes for 17 days in chemically defined medium on inert polycarbonate filters

Strain:

not specified

Test system

Controls:

other: Negative control: The absorption at 570 nm of the negative control tissues (treated with water) in the MTT-test is an indicator of tissue viability obtained after shipping and storing procedure and under specific conditions of the assay. Tissue viability

Duration of treatment / exposure:

The test substance, negative and positive control were tested on 2 tissues per application time (3 minutes and 1 hour). The test is meeting the acceptance criterion if the difference between two tissues treated identically is < 30 %.

Results and discussion

Any other information on results incl. tables

Mesterolone acetate (ZK 5894) was investigated regarding their potential skin irritating properties using SkinEthic reconstituted epidermis models. After 15 minutes of exposure to the neat substance and an additional incubation period of approximately 42 hours cell viability of the skin models treated with both test substances was comparable to the cell viability of the negative control. Therefore, ZK 5894 can be classified as non-irritating compound (no label required). In addition, the very low concentration of the proinflammatory IL-1¿released into the assay medium after approximately 24 and 42 hours of substance exposure supports this finding. IL-1¿levels were comparable after 24 and 42 hours with the exception of the positive control. Therefore, one time point for determination of the IL-1¿release is sufficient. Positive and negative control fulfilled the acceptance criteria indicating that the SkinEthic models used for testing had an acceptable quality after shipping under the specific assay conditions. Variability between the three tissues treated identically with the test compound, positive and negative control was acceptably low.

Applicant's summary and conclusion

Conclusions:

non-irritating

Executive summary:

Mesterolone acetate (ZK 5894) was investigated regarding their potential skin irritating properties using SkinEthic reconstituted epidermis models. After 15 minutes of exposure to the neat substance and an additional incubation period of approximately 42 hours cell viability of the skin models treated with both test substances was comparable to the cell viability of the negative control. Therefore, ZK 5894 can be classified as non-irritating compound (no label required).