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EC number: 217-968-7 | CAS number: 2022-85-7
- 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:
- 2004-06-07 - 2004-07-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
- Version / remarks:
- June 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- cascade impaction
- Remarks:
- Screening test: sieve method; Definitive test: cascade impactor method
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- Flucytosine
- EC Number:
- 217-968-7
- EC Name:
- Flucytosine
- Cas Number:
- 2022-85-7
- Molecular formula:
- C4H4FN3O
- IUPAC Name:
- flucytosine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- please refer to Test material information
Results and discussion
- Remarks on result:
- other: Too few particles were of a size less than 10 µm to allow accurate assessment of mass median aerodynamic diameter.
Particle size
- Key result
- Remarks on result:
- other: Too few particles were of a size less than 10 µm to allow accurate assessment of mass median aerodynamic diameter.
Particle size distribution at different passagesopen allclose all
- No.:
- #2
- Size:
- 10.2 µm
- Distribution:
- 10.9 %
- Remarks on result:
- other: Number given for No. specifies Cup Number
- No.:
- #3
- Size:
- 5.4 µm
- Distribution:
- 1.69 %
- Remarks on result:
- other: Number given for No. specifies Cup Number
- No.:
- #4
- Size:
- 2.5 µm
- Distribution:
- 0.928 %
- Remarks on result:
- other: Number given for No. specifies Cup Number
- No.:
- #5
- Size:
- 1.67 µm
- Distribution:
- 0.787 %
- Remarks on result:
- other: Number given for No. specifies Cup Number
- Size:
- 0.393 µm
- Distribution:
- 0.614 %
- Remarks on result:
- other: results for Filter
Any other information on results incl. tables
Screening test (sieve method)
The results of the sieving procedure are shown in the following table:
Sieve Aperture Size (µm) |
100 |
Mass of test material transferred to sieve (g) |
10.5 |
Mass of test material passed through sieve (g) |
4.0 |
Test material less than sieve aperture size (%) |
38.1 |
Definitive test (cascade impactor method)
The results of the cascade impactor method are shown in the attached study report (pg 35 -37).
The cumulative amounts found for the individual particle size cut-points (µm) are shown in the
following table:
Cup Number | Particle Size Cut-points (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10.2 |
0.3098 |
10.9 |
3 |
5.4 |
0.0479 |
1.69 |
4 |
2.5 |
0.0263 |
0.928 |
5 |
1.67 |
0.0223 |
0.787 |
Filter |
0.393 |
0.0174 |
0.614 |
The overall cumulative amounts of test material with a particle size less than 10 µm (%) from Determinations 1 to 3 are shown in the following table:
Determination | Cumulative Amount of Test Material Less Than 10 µm (%) |
Mean Cumulative Amount of Test Material Less Than 10 µm (%) |
1 |
11.8 |
see below |
2 |
15.3 |
12.7 |
3 |
10.9 |
see above |
Discussion
Too few particles were of a size less than 10 µm to allow accurate assessment of mass median aerodynamic diameter.
Representative sampling was ensured by rolling the sample container for approximately 10 minutes and sampling from the top, middle and bottom prior to definitive testing.
Applicant's summary and conclusion
- Conclusions:
- Particle size data acquired for the test material showed:
The proportion of test material having a particle size less than 100 µm , as determined by the sieve method, is 38.1%.
The proportion of test material having a particle size less than 10 µm, as determined by the Cascade Impactor method, is 12.7%.
The results indicate that the proportion by mass of particles which, if inhaled, can be expected to achieve pulmonary deposition in man is 12.7%.
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