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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
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).
Skin corrosion/irritation
Estrone was investigated regarding its potential skin irritating properties using a SkinEthic reconstituted epidermis model (EPISKIN Standard Model). After 15 minutes of exposure to the neat substance and an additional incubation period of 42 hours cell viability of the tissues treated with the test substance was comparable to the cell viability of the negative control tissues. Therefore, estrone can be classified as non-irritating compound .
Eye Irritation
Estrone was investigated regarding its potential eye irritating properties using the BCOP Test. It did not induce ocular irritation through the endpoints opacity and permeability, resulting in a mean in vitro irritancy score of -0.8 after 240 minutes of treatment. Therefore, estrone can be classified as non-irritating compound.
The test item was tested in the in vitro assay applying the Hen´s Egg Test on the Chorio-Allantoic Membrane (HET-CAM) test method. This is a method that makes use of the chorioallantoic mambrane (CAM) of fertilized chicken eggs. For determination of acut effects on haemorrhage, lysis of blood vessels and coagulation the undiluted test item was directly applied onto the CAM. for 5 minutes. The Irritation Score (IS) value was calculated to be 0 for the test item which was interpreted as being non irritant. The results of the positive ( SDS 1% in physiologic saline) and negative (physiologic saline solution) controls confirmed the validity of the test system.
The reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic™ HCE) was conducted with the test item. The undiluted test item was applied topically to the reconstructed HCE tissue. After an exposure period of 60 minutes followed by a 16 hours post-treatment incubation period the cell viability was measured to be about 95% by the MTT conversion assay. Thus the test item is predicted as non-irritant under the conditions of this test method.
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:
- Dec 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In Vitro Skin Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 (In Vitro Skin Irritation)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: three-dimensional human epidermis model (EPISKIN Standard Model of Skin Ethic Laboratories)
- Vehicle:
- water
- Controls:
- other: Negative control: phosphate buffered saline (PBS); Positive control: 5% (aq) Sodium dodecyl sulphate (SDS) in PBS
- Duration of treatment / exposure:
- 15 minutes exposure to the substance with an following incubation period of 42 hours at 37°C
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 99
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: negative
- Conclusions:
- non-irritating
- Executive summary:
Estrone was investigated regarding its potential skin irritating properties using a SkinEthic reconstituted epidermis model (EPISKIN Standard Model). After 15 minutes of exposure to the neat substance and an additional incubation period of 42 hours cell viability of the tissues treated with the test substance was comparable to the cell viability of the negative control tissues. Therefore, estrone can be classified as non-irritating compound .
Reference
Estrone did not interact with MTT.
After 15 minutes of exposure to the neat substance and an additional incubation period of 42 hours the mean tissue viability of tissues treated with the test substance was 99% (negative control tissues 100%, positive control tissues 12%).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Dec 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437 (BCOP test method)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: bovine eyes from young cattle; used as soon as possible after slaughter on the same day
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control: physiological saline; Positive control: 20% (w/v) Imidazole solution prepared in physiological saline
- Duration of treatment / exposure:
- 240 minutes
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- -0.8
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: negative
- Conclusions:
- not-irritating
- Executive summary:
Estrone was investigated regarding its potential eye irritating properties using the BCOP Test. It did not induce ocular irritation through the endpoints opacity and permeability, resulting in a mean in vitro irritancy score of -0.8 after 240 minutes of treatment. Therefore, estrone can be classified as non-irritating compound.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Principles of method if other than guideline:
- - Principle of test:
Assessment of ocular irritation potential of the test substance by determination of cytotoxic effects on a human corneal epithelium (HCE) cell model (similar to EpiOcular).
The HCE model is currently involved in the eye irritation validation conducted by COLIPA following ECVAM guidelines. Furthermore, it is routinely used by the major Cosmetic and Pharmaceutical companies, and has already been prevalidated in 2004 (van Goethem et. al., Tox in Vitro 20, 2006, 1-17). This model is recognized as the model of choice and scientifically relevant as documented by several publications (e.g. Alepee et. al., Toxicology in Vitro 34 (2016) 55–70). - GLP compliance:
- yes (incl. QA statement)
- Species:
- other: human corneal epithelial cells
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- The experiment was carried out on a Human Corneal Epithelial (HCE) Model, which is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE), SkinEthic, France). Inserts were of 0.5 cm² size. When cultivated at the air-liquid interface in a chemically defined medium, the immortalized human cornea epithelial cells reconstruct a corneal epithelial tissue (mucosa), without a stratum corneum, ultra-structurally (tissue morphology and thickness) similar to the corneal mucosa of the human eye.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg per insert, plus 30 µl PBS to moisten and ensure good contact to the tissue
- Duration of treatment / exposure:
- 60 min at room temperature
- Duration of post- treatment incubation (in vitro):
- 16 hours in the incubator (37°C, 5% CO2, maximum humidity)
- Number of animals or in vitro replicates:
- three
- Details on study design:
- The irritation potential of the test item is assessed by determination of its cytotoxic effect on an reconstructed human ocular epithelium. The test principle is based on the MTT assay reflecting the cell viability after exposure of the cornea equivalent to topically applied test item. The test item is applied pure. Since the test item is a solution (ca. 40% in ethyl acetate) the solvent is tested in parallel to distinguish potential toxic effects of the test item from the effects of the solvent. After the post-exposure incubation of 16 hours in the incubator (37 +/- 2 °C, 5 % CO2, maximum humidity) MTT reduction is performed. Cell viability is measured by the amount of MTT reduction, i.e. an OD value following exposure to the negative or positive control substances or the test item. A test substance is predicted to be an ocular irritant if the mean relative tissue viability (%) exposed to the test substance is ≤ 50 %.
- Irritation parameter:
- other: cell viability (%)
- Value:
- ca. 98
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: negative
- Executive summary:
The reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic™ HCE) was conducted with the test item. The undiluted test item was applied topically to the reconstructed HCE tissue. After an exposure period of 60 minutes followed by a 16 hours post-treatment incubation period the cell viability was measured to be about 95% by the MTT conversion assay. Thus the test item is predicted as non-irritant under the conditions of this test method.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix B3 of "ICCVAM Test Method Evaluation Report: Current Validation Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard Potential of Chemicals and Products", NIH Publication No. 10-7553, September 2010.
- Principles of method if other than guideline:
- - Principle of test: The Hen´s Egg Test on the Chorio-Allantoic Membrane (HET-CAM) is a test method which implies the use of a complete tissue constituted of blood vessels and proteins that is capable of responding to chemical injury with an inflammatory process similar to the one occuring in the conjunctival tissue of the eye.
- Short description of test conditions: The test substance is applied directly to the chorioallantoic membrane (CAM) of fertilized chicken eggs
- Parameters analysed / observed: acute effects on haemorrhage, lysis of blood vessels and coagulation - GLP compliance:
- yes (incl. QA statement)
- Details on test animals or tissues and environmental conditions:
- SOURCE OF FERTILIZED CHICKEN EGGS
- Source: Brinkschulte Josef GmbH & Co.KG, 48308 Senden
- Number of eggs: 4
- Characteristics of donor animals fertile Lohmann Brown hens
- Treatment conditions of eggs prior initiating testing: day 1-7: an incubator with an automatic rotating device (e.g. Ehret GmbH), optimum temperature : 37.5 °C, relative humidity 63%. day 8: with the large end
upward and not rotated for ensuring accessibility to the Chorioallantoic membrane (CAM) region
- Time interval prior to initiating testing: 8 days
- indication of any existing defects or lesions in eggs: After 7 days of incubation, all eggs were candled in order to discard those that were defect and to mark the air bubble. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 μl/egg which corresponded to an amount from an average of 190 mg
- Duration of treatment / exposure:
- 300 sec
- Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 4 eggs
- Details on study design:
- At day 8 of incubation the sections marked for the air bubble were sawed out of the shell. The inner membrane was moistened with NaCl 0.9 % and carefully removed with forceps. Only eggs with normally developed embryos and blood vessel systems were used for testing. Undilutet test item was applied directly onto the Chorioallantoic membrane (CAM) of each egg in a volume of 300 µL undiluted test item. 4 eggs each were used for the test item, negative and positive controls.
Observations of effects to the blood vessels, albumen or embryo over a period of 300 seconds after substance application are determined for each single egg. The time to the appearance of each of the observations mentioned above has been monitored and recorded. If no effect appeared during the observation period of 300 seconds (observation = 0) the result was assigned as negative for the related endpoint, and the factor set to 0 for this endpoint when calculating the Irritation Score (IS).
Scoring criteria for the acute effects and calculation of Irritancy Score (IS):
0 = no effect
1 = vasodilatation, slight haemorrhage (H)
2 = vessel lysis, strong haemorrhage (L)
3 = blood-coagulation, albumen-coagulation (C)
IS = 5 x (301-sec H)/300 + 7 x (301- sec L)/300 + 9 x (301- sec C)/ 300
H= observed start in seconds of haemorrhage reactions; L= observed start in seconds of vessel lysis, strong haemorrhage; C= observed start in seconds of blood - coagulation, albumen - coagulation
Data Interpretation:
Irritation Score (IS)
0-0.9 -> Non irritant
1-4.9 -> Slight irritant
5-8.9 -> Moderate irritant
9-21 -> Strong irritant
A test substance is considered to cause severe irritation when the IC value is greater than nine. - Irritation parameter:
- other: irritation score (IS)
- Run / experiment:
- mean
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: A test substance is considered to cause severe irritation when the IC value is greater than nine.
- Interpretation of results:
- other: negative
- Executive summary:
- The test item was tested in the in vitro assay applying the Hen´s Egg Test on the Chorio-Allantoic Membrane (HET-CAM) test method. This is a method that makes use of the chorioallantoic mambrane (CAM) of fertilized chicken eggs. For determination of acut effects on haemorrhage, lysis of blood vessels and coagulation the undiluted test item was directly applied onto the CAM. for 5 minutes. The Irritation Score (IS) value was calculated to be 0 for the test item which was interpreted as being non irritant. The results of the positive ( SDS 1% in physiologic saline) and negative (physiologic saline solution) controls confirmed the validity of the test system.
Referenceopen allclose all
The corneas treated with estrone showed opacity values ranging from -1 to 0 and permeability values ranging from 0.010 to 0.020. The corneas were clear after the 240 minutes of treatment with estrone. No pH effect of the test substance was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -0.9 to 0.2 after 240 minutes of treatment with estrone (for the negative controls it ranged from 0.0 to 0.9 and for the positive controls it ranged from 102 to 114).
Summary of opacity, permeability and in vitro scores:
Treatment | Mean Opacity | Mean Permeability | Mean in vitro Irritation Score |
Negative control | 0 | 0.000 | 0.0 |
Positive control | 81 | 1.672 | 106.1 |
Estrone | -1 | 0.015 | -0.8 |
Table 1: Tabular Summary of the results
Sample No. | Test item | OD mean* | StdDev | % Viability |
1 -3 | Negative control PBS | 0.80 | 0.03 | 100.00 |
4 -6 | Positive control SDS 0.3% | 0.09 | 0.08 | 11.34 |
7 -9 | Estrone | 0.79 | 0.03 | 98.37 |
*6 values
Table 1: Summary of results, test item
Egg | Effect | Effect detected after [sec] | Irritation Score (IS) |
9 | 1 | > 300 | |
2 | > 300 | ||
3 | > 300 | 0 | |
10 | 1 | > 300 | |
2 | > 300 | ||
3 | > 300 | 0 | |
11 | 1 | > 300 | |
2 | > 300 | ||
3 | > 300 | 0 | |
12 | 1 | > 300 | |
2 | > 300 | ||
3 | > 300 | 0 |
effect: 1 = vasodilatation, slight haemorrhage 2 = vessel lysis, strong haemorrhage 3 = blood-coagulation, albumen-coagulation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Due to the results with estrone no classification is required according to Regulation (EC) 1272/2008/EC (CLP), Annex I.
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.
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