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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
A registration of estrone was already submitted earlier and is public available on the ECHA website. Chapter 7, which is still valid from today's perspective, was amended to fulfill the current information requirements. Consequently the migrated data (IUCLID 5 to IUCLID 6) was kept unchanged and only modified if there was a need for further information and/or to pass the technical completeness check (TCC).
No acute toxicity studies were conducted with estrone; read across approach with results of studies with estron-methylether (ZK 5512). Estrone methylether is a steroidal hormone with a weak estrogenic activity. Pharmacological studies have yielded results which show that, despite the weak binding to the estrogen receptor in vitro, a full estrogenic effect can be expected following subcutaneous administration of 1 mg/kg estrone methylether in vivo in rats. It can thus to be assumed that the 3-methylether of the estrone in the mammalian organism is transformed into the estrogenically active natural hormone estrone (analogous to the transformation of mestranol into ethinylestradiol). Therefore, it is possible to use knowledge of estrone methylether for the assessment of estrone:
Acute oral toxicity:
The single oral administration of the test item to male and female Wistar rats at the dose of 2000 mg/kg resulted in transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from Day 2 onwards. No compound-related macroscopic findings were seen. The acute oral toxicity of the test item in rats is above 2000 mg/kg body weight.
Acute dermal toxicity:
The single dermal administration of the test item to male and female Wistar rats at the dose of 2000 mg/kg was tolerated without any clinical or macroscopic pathological findings. The acute dermal toxicity of the test item is above 2000 mg/kg body weight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29. Sep to 02. Nov 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Solubility and stability of the test substance in the solvent/vehicle: The mycrorystalline suspensions were prepared fresh on application day for immediate application and administrations were carried out within approximately 2 hours after preparation. The stability of the test item was verified analytically. In addition all samples are considered prepared correctly with regard to the results of analysis.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: Miglyol 812
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3/sex
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: Transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from day 2 onwards.
- Gross pathology:
- no effects observed
- Interpretation of results:
- other: no substance related mortality observed
- Conclusions:
- The acute oral toxicity of estrone-methylether in rats is above 2000 mg/kg body weight.
- Executive summary:
The single oral administration of estrone-methylether to male and female Wistar rats at the dose of 2000 mg/kg resulted in transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from Day 2 onwards. No compound-related macroscopic findings were seen. The acute oral toxicity of estrone-methylether in rats is above 2000 mg/kg body weight.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- No acute toxicity studies were conducted with estrone; read across approach with results of studies with estron-methylether (ZK 5512). Estrone methylether is a steroidal hormone with a weak estrogenic activity. Pharmacological studies have yielded results which show that, despite the weak binding to the estrogen receptor in vitro, a full estrogenic effect can be expected following subcutaneous administration of 1 mg/kg estrone methylether in vivo in rats. It can thus to be assumed that the 3-methylether of the estrone in the mammalian organism is transformed into the estrogenically active natural hormone estrone. Therefore, it is possible to use knowledge of estrone methylether for the assessment of estrone.
- Reason / purpose for cross-reference:
- read-across source
- Limit test:
- yes
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: Transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from day 2 onwards.
- Gross pathology:
- no effects observed
- Interpretation of results:
- other: no substance related mortality observed
- Conclusions:
- The acute oral toxicity of estrone-methylether in rats is above 2000 mg/kg body weight.
- Executive summary:
The single oral administration of the test item to male and female Wistar rats at the dose of 2000 mg/kg resulted in transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from Day 2 onwards. No compound-related macroscopic findings were seen. The acute oral toxicity of estrone-methylether in rats is above 2000 mg/kg body weight.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13. July to 14. Aug 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- not specified
- Vehicle:
- physiological saline
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3/sex
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occurred
- Clinical signs:
- other: The test substance was tolerated without any clinical findings.
- Gross pathology:
- The test substance was tolerated without any macroscopic pathological findings.
- Interpretation of results:
- other: no substance related mortality observed
- Conclusions:
- The acute dermal toxicity of estrone methylether is above 2000 mg/kg body weight.
- Executive summary:
The single dermal, 24 h-administration of the test item to male and female Wistar rats at the dose of 2000 mg/kg was tolerated without any clinical or macroscopic pathological findings. The acute dermal toxicity of the test item is above 2000 mg/kg body weight.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- No acute toxicity studies were conducted with estrone; read across approach with results of studies with estron-methylether (ZK 5512). Estrone methylether is a steroidal hormone with a weak estrogenic activity. Pharmacological studies have yielded results which show that, despite the weak binding to the estrogen receptor in vitro, a full estrogenic effect can be expected following subcutaneous administration of 1 mg/kg estrone methylether in vivo in rats. It can thus to be assumed that the 3-methylether of the estrone in the mammalien organism is transformed into the estrogenically active natural hormone estrone. Therefore, it is possible to use knowledge of estrone methylether for the assessment of estrone:
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occurred
- Clinical signs:
- other: The test substance was tolerated without any clinical findings.
- Gross pathology:
- The test substance was tolerated without any macroscopic pathological findings.
- Interpretation of results:
- other: no substance related mortality observed
- Conclusions:
- The acute dermal toxicity of estrone methylether is above 2000 mg/kg body weight.
- Executive summary:
The single dermal, 24 h-administration of estrone methylether to male and female Wistar rats at the dose of 2000 mg/kg was tolerated without any clinical or macroscopic pathological findings. The acute dermal toxicity of estrone methylether is above 2000 mg/kg body weight.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
A registration of estrone was already submitted earlier and is public available on the ECHA website. Chapter 7, which is still valid from today's perspective, was amended to fulfill the current information requirements. Consequently the migrated data (IUCLID 5 to IUCLID 6) was kept unchanged and only modified if there was a need for further information and/or to pass the technical completeness check (TCC).
Additionally results of acute toxicity studies with estrone are cited in RTECS database (Aug 2011):
A acute oral toxicity study in rats results in LD50 >5000 mg/kg [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (6), p. 25, 1994 (TOVEFN)]
A acute oral toxicity study in mice results in LD50: >5000 mg/kg [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (6), p. 25, 1994 (TOVEFN)]
Acute inhalation toxicity study in rats results in effects on spermatogenesis (including genetic material, sperm morphology, motility, and count) with a TCLo: 0.005 mg/m3/4H; LD50 is not reported [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (6), p. 25, 1994 (TOVEFN)]
Acute inhalation toxicity study in rats results in effects on testes, epididymis and sperm duct with a TCLo: 0.01 mg/m3/4H; LD50 is not reported [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (6), p. 25, 1994 (TOVEFN)]
Acute dermal toxicity study in rats results in endocrine effect on menstrual cycle with TDLo: 0.1 mg/kg; LD50 is not reported [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (6), p. 25, 1994 (TOVEFN)]
Acute inhalation toxicity data in rats result in endocrine effect on menstrual cycle with TCLo: 0.01 mg/m3; LD50 is not reported [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (6), p. 25, 1994 (TOVEFN)]
Justification for classification or non-classification
Based on the data for surrogate no classification for acute toxicity (oral, dermal) according to Regulation (EC) No. 1272/2008 (CLP) is required for estrone.
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.
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