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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 601-419-7 | CAS number: 1162-60-3
- 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_physical-and-chemical-properties.png)
Appearance / physical state / colour
Administrative data
- Endpoint:
- appearance / physical state / colour
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 September 2017 - 14 February 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 September 2017 - 14 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 (Particle size analysis by laser diffraction)
- Version / remarks:
- Handbook K, 2007
- Deviations:
- no
- Principles of method if other than guideline:
- According to REACH Article 13(3) tests on substances shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. No particle size distribution test method is laid down in regulation (EC) No 440/2008. OECD 110 TG ‘Particle Size Distribution/Fibre Length and Diameter Distributions’ dates from 1981 and describes two methods in detail; both methods have restrictions and are not applicable to the entire size range. ECHA’s Guidance on information requirements and Chemical Safety Assessment-Chapter R.7a stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. The guidance mentions Laser scattering/diffraction as a method for particles of all kind and makes reference to ISO 13320:2009.
According to Guidance document EUR 20268 (2002), the laser diffraction technique is applicable to particles of respirable and inhalable size. The MMAD can be calculated when density is known. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dd 13 January 2016
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
- Specific details on test material used for the study:
- Relative density: 1.18
Test item was tested as received. - Mass median aerodynamic diameter:
- 374.313 µm
- Geometric standard deviation:
- >= 3.271 - <= 3.409
- Remarks on result:
- other: The MMAD above is the average of 5 runs. GSD was calculated from d50/d15.78. The min. and max. GSD values of 5 runs are provided above. The St.dev. in the table below is the population standard deviation [µm].
- Key result
- Percentile:
- D10
- Mean:
- 53.528 µm
- St. dev.:
- 1.032
- Remarks on result:
- other:
- Remarks:
- std. dev. of the population
- Key result
- Percentile:
- D50
- Mean:
- 344.583 µm
- St. dev.:
- 5.142
- Remarks on result:
- other:
- Remarks:
- std. dev. of the population
- Key result
- Percentile:
- D90
- Mean:
- 786.632 µm
- St. dev.:
- 15.699
- Remarks on result:
- other:
- Remarks:
- std. dev. of the population
- No.:
- #1
- Size:
- < 10 µm
- Distribution:
- 0.76 %
- Remarks on result:
- other:
- Remarks:
- volume of sample
- Conclusions:
- Particle size distribution of the substance was determined as follows: D10 = 53.528 µm, D50 = 344.583 µm and D90 = 786.632 µm.
0.76% by volume was determined to be smaller than 10 µm.
The MMAD was calculated to be 374.313 µm. - Executive summary:
The particle size distribution of the substance was determined using laser diffraction analysis (dry powder module) in a GLP study according to ISO 13320 and CIPAC MT 187. Each result is the average of five runs. D10 = 53.528 µm, D50 = 344.583 µm and D90 = 786.632 µm. 0.76% by volume was determined to be smaller than 10 µm. The MMAD was calculated to be 374.313 µm.
Conclusion of visual and microscopic evaluation:
- visual observation: fine off-white powder with some fines and clusters
- observation using 3.2 objective lens: irregular shaped crystals (range of individual particle size was approximately 10 μm - approximately 560 μm).
- observation using 40 objective lens: single crystalline particles.
Laser Diffraction Particle Size Analysis:
Coefficient of variation for D50 is < 3%; D10 and D90 are < 5%.
Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320 standard.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The appearance was determined by visual observation (direct and under a microscope). No guideline was followed for the appearance determination but sufficient details were given in the study report.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dd 13 January 2016
Test material
- Reference substance name:
- 19-norpregn-4-en-20-yn-3-one, 17-hydroxy-7-methyl, (7alpha, 17alpha-)
- EC Number:
- 601-419-7
- Cas Number:
- 1162-60-3
- Molecular formula:
- C21H28O2
- IUPAC Name:
- 19-norpregn-4-en-20-yn-3-one, 17-hydroxy-7-methyl, (7alpha, 17alpha-)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical appearance: off-white to beige powder
- Test item storage: at room temperature
Constituent 1
Results and discussion
- Physical state at 20°C and 1013 hPa:
- solid
Form / colour / odour
- Key result
- Form:
- solid: particulate/powder
- Colour:
- Off-white to beige
- Odour:
- other: not determined
- Substance type:
- organic
Any other information on results incl. tables
A test substance sample was observed to be a medium to coarse, off-white to beige powder with some fines and clusters.
From observations using a 3.2 objective lens, the particles appeared to be irregular shaped crystals.
From observations using a 40 objective lens, the sample was observed to be made up of single crystalline particles.
Applicant's summary and conclusion
- Conclusions:
- The substance is an off-white to beige powder at room temperature.
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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