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EC number: 200-554-5 | CAS number: 63-05-8
- 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
Endpoint summary
Administrative data
Description of key information
in vitro skin irritation: not irritating (Wingenroth, 2021)
in vivo skin irritation: not irritating (Kurth, 1996)
in vivo eye irritation: not irritating (Treher, 1995)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Oct 2020 - 22 Oct 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2020
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: no data available
- Justification for test system used:
- accordign to guideline
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: reconstructed human epidermis model epiCS® (Cat.-No.CS-1001, CellSystems, Troisdorf, Germany)
- Tissue batch number(s): 100·AJ0414-1
- Date of initiation of testing: 19-10-2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: RT (room temperature)
- Temperature of post-treatment incubation (if applicable): Incubator temperature: 37 ± 2° C (CO2 gas concentration: 5 %; Humidity: 95%)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 hours
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed control and Color control were not required.
NUMBER OF TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: the optical density of the isopropanol-extracts of 3 insert was determined by duplicate per insert = 6 OD values.
PREDICTION MODEL / DECISION CRITERIA:
- The mean optical density (OD) values obtained with the test item were used to calculate the percentage of viability relative to the negative control, which is set at 100 %.
- according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after exposure and post treatment incubation is less than or equal (≤ ) to 50 %.
Acceptance criteria:
The following acceptance criteria determined the validity of an assay:
- mean OD negative control >/=0.8 and = 2.8
- mean relative viability of the positive control is = 20 %
- If the mean viability of the 3 replicates > 20% the coefficient of variation (CV) should not exceed 0.3. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg (plus 30 µl 0.9% NaCl to moisten and ensure good contact with the epidermis surface)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl
- Concentration (if solution): 0.9% NaCl in water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl
- Concentration (if solution): 5% SDS in physiological saline - Duration of treatment / exposure:
- 20 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 114.89
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: no
- Colour interference with MTT: no
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
Reliability of the test was previously confirmed by interlaboratory validation
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes - Conclusions:
- A study was performed for the assessment of the skin irritancy of the test item Androstendione with reconstructed human epidermis (RhE) in accordance with OECD TG 439 and EU Test Method B.46.
The mean value of cell viability was recorded to be 114.89%. The test item was thus shown to be not irritating to reconstructed human skin in vitro. - Executive summary:
A study was performed for the assessment of the skin irritancy of the test item Androstendione with reconstructed human epidermis (RhE). The experiment was carried out in vitro using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 439 and EU Test Method B.46.
The test item was applied undiluted topically to the RhE tissue construct in triplicates and incubated for 20 minutes, followed by a 42 hours post-treatment incubation period.
Cell viability was measured in a photometer by the amount of MTT (methylthiazole tetrazolium) reduction. The optical density value obtained for the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100%.
The results of the concurrent negative control (NC, 0.9 % NaCl) and positive control (PC, 5 % SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.
The following value of cell viability was recorded for the test item: 114.89%.
In conclusion the results of the assay used show no skin irritant properties of the test item Androstendion.
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 Feb. 87
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: females
- Source: Schriever
- Age at study initiation: not reported
- Weight at study initiation: 3.4-4.4 kg
- Housing: singly in conventional housing conditions (metal cage)
- Diet and water: ad libitum
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 48-56
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye remained untreated and served as control
- Amount / concentration applied:
- 0.1 mL, corresponding to 54.0-64.3 mg substance
- Duration of treatment / exposure:
- 0.1 mL substance was applied into the conjunctival sac of the right eye; no rinsing of the eyes reported.
- Observation period (in vivo):
- Examinations were terminated after 4 days, since no changes at all were observed during this period.
- Number of animals or in vitro replicates:
- 4 (females)
- Details on study design:
- One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed. Conjunctivae, eyelids, cornea and iris were evaluated before application, 0.5, 1 and 2 hours thereafter and then once daily until termination of the study on day 4.
SCORING SYSTEM:
According to "Illustrated Guide for Grading Eye Irritation by Hazardous Substances", US Department of Health, Education and Welfare, Food and Drug Administration, Washington DC 20204, USA. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The single application of the substance into the conjunctival sac of the rabbit eye led to slight to moderate transient irritation (vessel injection and secreation in 2/4 animals) solely on the day of application. From day 2 onwards all animals were without findings.
- Other effects:
- not reported
- Conclusions:
- The test item was tolerated without any local findings in 2 of 4 animals. Only one animal each showed slight injection of blood vessels in the conjunctiva palpebrae and moderate secretion, respectively, on application day. From day 2 onwards, both animals were without findings as well. In this study, Androstendion was not irritating to the eye.
- Executive summary:
In a primary eye irritation study according to OECD TG 405 0.1 ml Androstendione (corresponding to 54.0 to 64.3 mg) was instilled into the conjunctival sac of the right eye of New Zealand White rabbits (4 females). The untreated left eye served as control. Animals were observed for 4 d. Conjunctivae, eyelids, cornea and iris were evaluated before application, 0.5, 1 and 2 hours thereafter, and then once daily until termination of the study on day 4.
The test item was tolerated without any local findings in 2 of 4 animals. Only one animal each showed slight injection of blood vessels in the conjunctiva palpebrae and moderate secretion, respectively, on application day. From day 2 onwards, both animals were without findings as well. The control eyes were without findings. In this study, Androstendion was not irritating to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A study was performed for the assessment of the skin irritancy of the test item Androstendion with reconstructed human epidermis (RhE). The experiment was carried out in vitro using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 439 and EU Test Method B.46.
The test item was applied undiluted topically to the RhE tissue construct in triplicates and incubated for 20 minutes, followed by a 42 hours post-treatment incubation period.
Cell viability was measured in a photometer by the amount of MTT (methylthiazole tetrazolium) reduction. The optical density value obtained for the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100%.
The results of the concurrent negative control (NC, 0.9 % NaCl) and positive control (PC, 5 % SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.
The following value of cell viability was recorded for the test item: 114.89%.
In conclusion the results of the assay used show no skin irritant properties of the test item Androstendion (Wingenroth, 2021).
In a combined study on acute toxicity and on local tolerance similar to OECD TG 402 Wistar rats (3/sex) were dermally exposed to Androstendion in physiological saline for 24 hours at a limit dose of 2000 mg/kg bw under semiocclusive conditions. Animals then were observed for 14 days.
The administration of the test substance was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings.
No local intolerance reactions at the application sites were observed (Kurth, 1996).
Eye irritation
In a primary eye irritation study according to OECD TG 405 0.1 ml Androstendion (corresponding to 54.0 to 64.3 mg) was instilled into the conjunctival sac of the right eye of New Zealand White rabbits (4 females). The untreated left eye served as control. Animals were observed for 4 d. Conjunctivae, eyelids, cornea and iris were evaluated before application, 0.5, 1 and 2 hours thereafter, and then once daily until termination of the study on day 4.
The test item was tolerated without any local findings in 2 of 4 animals. Only one animal each showed slight injection of blood vessels in the conjunctiva palpebrae and moderate secretion, respectively, on application day. From day 2 onwards, both animals were without findings as well. The control eyes were without findings. In this study, Androstendion was not irritating to the eye (Treher, 1995).
No study investigating a respiratory irritant potential of the substance is available. But as no irritant potential was seen in the above specified in vivo irritation/corrosion studies on skin and eye (all scores zero at 24, 48, and 72 h), it is unlikely that the substance would show a respiratory irritant property.
Justification for classification or non-classification
No classification required for skin, eye or respiratory irritation/corrosion according to Regulation (EC) 1272/2008.
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