Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- 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:
- The Effects of DHEA on Reproductive Toxicity in Rats
- Author:
- Lin J, He L, Lin S, Liu S
- Year:
- 2 006
- Bibliographic source:
- Carcinogenesis, Teratorgenesis & Mutagenesis 18(6) 479-481
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Limit test:
- no
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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- From day 7 to day 16 of pregnancy
- Frequency of treatment:
- continuous administration (no further specifications)
- Details on study schedule:
- Rats were given test item from day 7 to day 16 of pregnancy, and sacrificed on day 20 of pregnancy.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Distilled water-negative control
- Dose / conc.:
- 10.4 mg/kg bw/day
- Dose / conc.:
- 20.8 mg/kg bw/day
- Dose / conc.:
- 41.7 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Remarks:
- Aspirin-positive control
- No. of animals per sex per dose:
- 16 pregnant females per dose group
- Control animals:
- yes
- Positive control:
- Aspirin, 300 mg/kg
Examinations
- Postmortem examinations (parental animals):
- SACRIFICE
- Maternal animals: All surviving animals sacrified on day 20 of pregnancy
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 20.8 and 41.7 mg/kg slowed down the weight increase of mother and fetuses and slowed sternum growth.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- DHEA at 10.4 mg/kg caused miscarriages in pregnant rats.
Effect levels (P0)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 10.4 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 10.4 mg/kg bw/day (nominal)
- System:
- female reproductive system
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: P1 (second parental generation)
Reproductive function / performance (P1)
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- All three concentrations of DHEA decreased the number of living fetuses
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- Miscarrriages increased at 10.4 mg/kg. All three concentrations of DHEA decreased the number of living fetuses.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 20.8 and 41.7 mg/kg slowed down the weight increase of mother and fetuses and slowed sternum growth.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- At 41.7 mg/kg, visceral abnormality in fetuses increased.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 10.4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- body weight and weight gain
Target system / organ toxicity (F1)
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 10.4 mg/kg bw/day (nominal)
- System:
- other: viability, body weight
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Results: F2 generation
General toxicity (F2)
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
Overall reproductive toxicity
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 10.4 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Maternal and fetal toxicity of DHEA is investigated. SD pregnant female rats were divided randomly into 5 gorups, 16 rats per group. The rats in the positive control group received aspirin 300 mg/kg and distilled water was given to rats as the negative control group. Three DHEA groups were treated with 10.4, 20.8 and 41.7 mg/kg. The rats were given DHEA from 7d to 16d pregnant continuously for 10 days, and were sacrificed on 20th day of pregnancy. Adverse effects on pregnant rats and fetuses were assessed. DHEA at 10.4 mg/kg caused miscarriages in pregnant rats. 20.8 and 41.8 mg/kg slowed down the weight increase of mothher and fetuses, and slowed sternum growth. At 41.7 mg/kg visceral abnormality in fetuses increased. All three concentrations of DHEA decreased the number of living fetuses. In conclusion, DHEA had adverse effects in both pregnant rats and fetuses.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.