Registration Dossier
Registration Dossier
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: 200-164-5 | CAS number: 53-16-7
- 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

Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Estradiol
- EC Number:
- 200-023-8
- EC Name:
- Estradiol
- Cas Number:
- 50-28-2
- Molecular formula:
- C18H24O2
- IUPAC Name:
- estra-1,3,5(10)-triene-3,17-diol
- Details on test material:
- - Name of test material (as cited in study report): estradiol
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- female
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- castor oil
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 52 or 66 weeks
- Frequency of treatment:
- every 3rd daily (day 1, 4, 7, 10, ...) or weekly
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.28 mg/kg every third day or once weekly
- No. of animals per sex per dose:
- 6/group
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Effect level:
- < 1.28 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: ovarian carcinoma
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Alopecia, alteration of mammary gland, vaginal discharge, anemia, transient leucocytosis, thrombocytopenia, decrease of reticulocytes, enhanced erytrocyte sedimetation rate, increased fibrinogen and coagulation time, increase in glucose and cholesterol..
Parenchymal and follicular atrophy of ovaries, papillary hyperplasia in ovaries, intestinal fibrosis of endometrium, atrophy and cystic dilatation of endometrial gland, hypertrophy and fibrosis of myometrium, increase in thickness of vaginal epithelium, edema and thickening of vulva propria and parenchymal proliferation of mammary gland, cortical nodular hyperplasia and marked depetion of lipid content of adrenal gland.
Applicant's summary and conclusion
- Conclusions:
- Classification is not required.
- Executive summary:
The administration of 1.28 mg/kg twice or once a week in female dogs over a period of 52 to 66 weeks did not produce any morphological features that indicate any neoplastic or anaplastic processes. Benign proliferative leasions of mesothelium lining of genital organs together with clinical, biochemical and haematological changes known to be related to estrogen effects were observed.
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.
