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Diss Factsheets
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EC number: 200-370-5 | CAS number: 58-22-0
- 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
Endpoint summary
Administrative data
Description of key information
ZK 5155 (androstenedione) did not show a skin irritating or corrosive potential in rats when administered semi-occlusively to the back for 24 hours. ZK 5155 provoked slight to moderate transient irritations (vessel injection and secreation in 2/4 animals) on the rabbit eye after single interconjunctival application on the day of administration. ZK5155 is not regarded as an eye irritant.
Based on data from the read across substance androstenedione, testosterone is not considered to be a skin or eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 23. Feb to 22. March 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: see principles of method
- Principles of method if other than guideline:
- Combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.3 ml) to male and female rats; occlusive conditions; exposure for 24 hours; values for reddening, scab formation and swelling obtained immediately after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Type of coverage:
- semiocclusive
- Vehicle:
- physiological saline
- Controls:
- no
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 days
- Number of animals:
- 3/sex
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 30-60 min, 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- none
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Testosterone is not classified according to Directive 67/548/EEC and Regulation 1272/2008/EC (CLP) criteria, based on no irritating potential in vivo of the read-across substance, androstenedione
- Executive summary:
There are no available skin irritation studies on testosterone. Results of a study conducted with a structurally similar compound (androstenedione, ZK5155) are reported and used for read-across.
ZK 5155 did not show a skin irritating or corrosive potential in rats when administered semi-occlusively to the back for 24 hours.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline, GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as control
- Duration of treatment / exposure:
- substance was not flushed out, application of 0.1 ml substance only into the right eye
- Observation period (in vivo):
- 0.5, 1, 2, h after application and then every 24 h until day 4 of test
- Number of animals or in vitro replicates:
- 4 animals
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- ZK 5155 provoked slight to moderate transient irritations (vessel injection and secreation in 2/4 animals) on the rabbit eye after single interconjunctival application on the day of administration.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Testosterone is not classified according to Directive 67/548/EEC and Regulation 1272/2008/EC (CLP) criteria, based on no irritating potential in vivo of read-across substance androstenedione.
- Executive summary:
There are no available eye irritation studies on testosterone. Results of a study conducted with a structurally similar compound (androstenedione, ZK5155) are reported and used for read-across.
ZK 5155 provoked slight to moderate transient irritations (vessel injection and secretion in 2/4 animals) on the rabbit eye after single interconjunctival application on the day of administration. ZK5155 is not regarded as an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Read-across justification summary is attached to this endpoint summary.
Justification for classification or non-classification
Based on read across to androstenedione, testosterone is not classifiable as either a skin or an eye irritant according to Directive 67/548 EEC or Regulation (EC) 1272/2008 (CLP).
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