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Diss Factsheets
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EC number: 223-768-0 | CAS number: 4062-46-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 006
- 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
- 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
Constituent 1
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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