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EC number: 824-341-7 | CAS number: 357338-13-7
- 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

Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03/01/2019 - 14/02/2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- relative density
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Jan 2019 - 14 Feb 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.3 (Relative Density)
- Version / remarks:
- 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 109 (Density of Liquids and Solids)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7300 (Density / Relative Density / Bulk Density)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- air comparison pycnometer (for solids)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was dried for 44 hours in a desiccator under vacuum using silica gel as the drying agent at 18.7 ± 0.1°C and protected from light. - Key result
- Type:
- relative density
- Density:
- 1.1 other: dimensionless
- Temp.:
- 20 °C
- Remarks on result:
- other: D 20 /4
- Key result
- Type:
- density
- Density:
- 1.1 g/cm³
- Temp.:
- 20 °C
- Conclusions:
- The relative density D20/4 of the substance was determined to be 1.10.
- Executive summary:
The relative density of the substance was determined in a GLP study according to EC A.3, OECD 109 and OPPTS 830.7300 (method: air comparison pycnometer (for solids)).
A gas comparison pycnometer was used with Helium as the gas. The relative density D20/4 was determined in duplicate obtaining a mean value of 1.10.
Relative density:
Experiment 1: 1.102
Experiment 2: 1.104
Mean: 1.10
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 (Particle size analysis by laser diffraction)
- Version / remarks:
- Handbook K, 2007
- 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/FibreLength 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)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- (S)-2-(5-Oxo-3-propyl-1,2-dihydropyrrol-1-yl) butyramide
- Cas Number:
- 357338-13-7
- Molecular formula:
- C11H18N2O2
- IUPAC Name:
- (S)-2-(5-Oxo-3-propyl-1,2-dihydropyrrol-1-yl) butyramide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Off-white powder
- Storage condition of test material: In refrigerator protected from light
Constituent 1
- Specific details on test material used for the study:
- Relative density: 1.10 (see Cross-reference)
Results and discussion
- Mass median aerodynamic diameter:
- 24.1 µm
- Geometric standard deviation:
- >= 2.524 - <= 2.565
- Remarks on result:
- other: MMAD and GSD above are both the average of 5 runs. GSD was calculated from d50/d15.78. The St.dev. in the table below is the population standard deviation [µm].
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 7.92 µm
- St. dev.:
- 0.049
- Key result
- Percentile:
- D50
- Mean:
- 23 µm
- St. dev.:
- 0.136
- Key result
- Percentile:
- D90
- Mean:
- 87.7 µm
- St. dev.:
- 1.12
Particle size distribution at different passages
- No.:
- #1
- Size:
- < 10 µm
- Distribution:
- 16 other: vol%
Any other information on results incl. tables
Coefficient of variation for D50 is < 3%; D10 and D90 are < 5%. These values are within the acceptable limits mentioned in the ISO 13320 standard.
Applicant's summary and conclusion
- Conclusions:
- Particle size distribution of the substance: D10= 7.92 µm, D50= 23.0 µm and D90= 87.7 µm. 16% by volume was determined to be smaller than 10 µm. The MMAD was calculated to be 24.1 µm.
- Executive summary:
Laser diffraction analysis (dry powder module) was performed in a GLP study according to ISO 13320 and CIPAC MT 187. The sample was tested as such. Each result is the average of five runs. Particle size distribution of the substance: D10= 7.92 µm, D50= 23.0 µm and D90= 87.7 µm. 16% by volume was determined to be smaller than 10 µm. The MMAD was calculated to be 24.1 µm.
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