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EC number: 212-714-1 | CAS number: 853-23-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test material
- Reference substance name:
- Prasterone
- EC Number:
- 200-175-5
- EC Name:
- Prasterone
- Cas Number:
- 53-43-0
- Molecular formula:
- C19H28O2
- IUPAC Name:
- (3S,8R,9S,10R,13S,14S)-3-hydroxy-10,13-dimethyl-1,2,3,4,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-one
- Test material form:
- solid
- Details on test material:
- white solid
Constituent 1
Test animals
- Species:
- other: rat & rabbit
- Strain:
- other: CD rat & New Zealand White rabbit
Administration / exposure
- Route of administration:
- other: oral (no further specifications)
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Rabbits received DHEA during GD7-20 (GD0 - day of observed mating).
Rats received DHEA during GD6-17 (GD0 = day of vaginal plug) - Frequency of treatment:
- Daily
- Duration of test:
- 10 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- rat, Control, group 1
- Dose / conc.:
- 5 mg/kg bw/day
- Remarks:
- rat, group 2
- Dose / conc.:
- 15 mg/kg bw/day
- Remarks:
- rat, group 3
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- rat, group 4
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- rabbit, group 1
- Dose / conc.:
- 20 mg/kg bw/day
- Remarks:
- rabbit, group 2
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- rabbit, group 3
- Dose / conc.:
- 125 mg/kg bw/day
- Remarks:
- rabbit, group 4
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Rabbits: fetuses were obtained by cesariian section on gestation day 29
- Rats: fetuses were obtained by cesarean section on GD20
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- no mortality observed
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- effects observed, treatment-related
- Description (incidence and severity):
- in rats, embryolethality and increased early resorptions occurred at all dose levels including complete litter loss in 2 litters at 5 mg/kg/day and 3 litters each at 15 and 50 mg/kg/day.
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- in rats, embryolethality and increased early resorptions occurred at all dose levels including complete litter loss in 2 litters at 5 mg/kg/day and 3 litters each at 15 and 50 mg/kg/day. Litter loss was confirmed after immersion of uteri in ammonium sulfide solution.
- Early or late resorptions:
- effects observed, treatment-related
- Description (incidence and severity):
- in rats, embryolethality and increased early resorptions occurred at all dose levels including complete litter loss in 2 litters at 5 mg/kg/day and 3 litters each at 15 and 50 mg/kg/day.
- Details on maternal toxic effects:
- rabbits: There were no effects on embryonic and fetal development
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- rabbit
- Effect level:
- 125 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no effects on embryonic and fetal development
- Dose descriptor:
- LOAEL
- Remarks:
- rat
- Effect level:
- 5 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- early or late resorptions
- total litter losses by resorption
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- in rats: Increased numbers of litters with bent ribs occurred at all concentrations. Increased numbers of litters with reduced ossification of cervical arches was seen at 50 mg/kg/day
- Description (incidence and severity):
- in rabbits, there were no effects on embryonic or fetal development
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- rabbit
- Effect level:
- 125 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no effects on embryonic and fetal development
- Dose descriptor:
- LOAEL
- Remarks:
- rat
- Effect level:
- 5 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- reduction in number of live offspring
- changes in postnatal survival
- skeletal malformations
Fetal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- skeletal: rib
- skeletal: vertebra
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 5 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No effects on embryonic or fetal development were observed in New Zealand White rabbits , dosed orally during GD7-20 with DHEA at dose levels of 0, 20, 50 or 125 mg/kg/day.
In the same study, CD rats were dosed orally with DHEA during GD6-17 at dose levels 0, 5, 15 or 50 mg/kg/day. Embryolethality and increased early resorptions occurred at all dose levels in rats, including complete litter loss. Skeletal malformations were also observed. DHEA may may interfere with the energy requirements of the developing embryo or perturb to hormonal balance necessary to maintain implantation.
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