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EC number: 700-361-0 | CAS number: 361442-00-4
- 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:
- Experimental Starting Date: 08 August 2012 Experimental Completion Date: 23 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The method used is based on a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 EN 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' of 2002.
- Deviations:
- no
- Principles of method if other than guideline:
- See above
- GLP compliance:
- yes
Test material
- Reference substance name:
- BMS-528233-01
- IUPAC Name:
- BMS-528233-01
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: BMS-528233-01
Description: White powder
BMS Batch Number: 2C80150N
Vendor Batch Number LTBB2S1005
Structure: Please see Attachment 1 of this Summary
Molecular Formula: C17H27NO5
Molecular Weight: 325.41
Purity: >100 %
Expiry Date: 31 January 2015
Storage Conditions: Room temperature, in the dark
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Mean:
- other: Not applicable
Any other information on results incl. tables
Results
Screening test (sieve method)
The results of the sieving procedure are shown in the following table:
Table 3.9
Measurement |
Result |
Mass of test item transferred to sieve |
10.03 g |
Mass of test item passed through sieve |
1.57 g |
Proportion of test item <100 µm |
15.7 % |
Definitive test (cascade impactor method)
The results of the cascade impactor method determinations are shown as follows:
Determination 1
Table 3.10
Collection Stage |
Particle Size Range Collected (µm) |
Mass (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.1204 |
88.5795 |
2.4591 |
Cup 2 |
5.5 to 10.0 |
85.5629 |
85.6593 |
0.0964 |
Cup 3 |
2.4 to 5.5 |
85.9144 |
85.9201 |
0.0057 |
Cup 4 |
1.61 to 2.4 |
85.6927 |
85.6928 |
0.0001 |
Cup 5 |
0.307 to 1.61 |
85.8629 |
85.8624 |
-0.0005* |
Filter |
<0.307 |
75.5211 |
75.5233 |
0.0022 |
Mass of test item found in artificial
throat: 0.48 g.
Total mass of test item recovered from artificial throat, sample cups
and filter: 3.0435 g.
* Value of 0.0000 g used in further calculations. Negative value withinuncertainty of the balance accuracy.
Determination 2
Table 3.11
Collection Stage |
Particle Size Range Collected (µm) |
Mass (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.1220 |
88.9364 |
2.8144 |
Cup 2 |
5.5 to 10.0 |
85.5660 |
85.6088 |
0.0428 |
Cup 3 |
2.4 to 5.5 |
85.9239 |
85.9295 |
0.0056 |
Cup 4 |
1.61 to 2.4 |
85.6936 |
85.6945 |
0.0009 |
Cup 5 |
0.307 to 1.61 |
85.8657 |
85.8668 |
0.0011 |
Filter |
<0.307 |
75.5212 |
75.5244 |
0.0032 |
Mass of test item found in artificial
throat: 0.24 g.
Total mass of test item recovered from artificial throat, sample cups
and filter: 3.1080 g
Determination 3
Table 3.12
Collection Stage |
Particle Size Range Collected (µm) |
Mass (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.1251 |
88.6162 |
2.4911 |
Cup 2 |
5.5 to 10.0 |
85.5631 |
85.5890 |
0.0259 |
Cup 3 |
2.4 to 5.5 |
85.9242 |
85.9282 |
0.0040 |
Cup 4 |
1.61 to 2.4 |
85.6928 |
85.6944 |
0.0016 |
Cup 5 |
0.307 to 1.61 |
85.8666 |
85.8673 |
0.0007 |
Filter |
<0.307 |
75.5235 |
75.5237 |
0.0002 |
Mass of test item found in artificial
throat: 0.57 g.
Total mass of test item recovered from artificial throat, sample cups
and filter: 3.0935 g.
Cumulative amounts
The cumulative amounts of test item found in the three determinations for the individual particle size cut-points are shown in the following table:
Table 3.13
Particle Size Cut-point (µm) |
Cumulative Mass (g) |
Cumulative Percentage (%) |
||||
Determination 1 |
Determination 2 |
Determination 3 |
Determination 1 |
Determination 2 |
Determination 3 |
|
10.0 |
0.1044 |
0.0536 |
0.0324 |
3.43 |
1.73 |
1.05 |
5.5 |
0.0080 |
0.0108 |
0.0065 |
0.263 |
0.347 |
0.210 |
2.4 |
0.0023 |
0.0052 |
0.0025 |
7.56x 10-2 |
0.167 |
8.08 x 10-2 |
1.61 |
0.0022 |
0.0043 |
0.0009 |
7.23x 10-2 |
0.138 |
2.91 x 10-2 |
0.307 |
0.0022 |
0.0032 |
0.0002 |
7.23x 10-2 |
0.103 |
6.47 x 10-3 |
The overall cumulative percentage (%) of test item with a particle size less than 10.0 µm and 5.5 µm are shown in the following table:
Table 3.14
Particle size |
Cumulative Percentage (%) |
|||
Determination 1 |
Determination 2 |
Determination 3 |
Mean |
|
<10.0 µm |
3.43 |
1.73 |
1.05 |
2.07 |
<5.5 µm |
0.263 |
0.347 |
0.210 |
0.273 |
Applicant's summary and conclusion
- Conclusions:
- Please see the Executive Summary for the Conclusion Section of the report.
- Executive summary:
The method used is based on a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 EN 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' of 2002.
Conclusion
Particle size data acquired for the test item is shown in the following table:
Table 3.15
Measurement
Method
Result
Proportion of test item having an inhalable particle size <100 µm
Sieve
15.7 %
Proportion of test item having a thoracic particle size <10.0 µm
Cascade Impactor
2.07 %
Proportion of test item having a respirable particle size <5.5 µm
Cascade Impactor
0.273 %
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