Registration Dossier
Registration Dossier
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EC number: 435-990-7 | CAS number: 371921-34-5
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 16 to March 20, 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Principles of method if other than guideline:
- EUROPEAN COMMISSION, Directorate General Xll-JRC, Science Research and DevelopmenþJoint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document, ECB/TM/February 1996
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- Yellow 981
- IUPAC Name:
- Yellow 981
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Percentile:
- D50
- Mean:
- < 1.67 µm
- St. dev.:
- 0.019
- Percentile:
- D10
- Mean:
- < 0.65 µm
- St. dev.:
- 0
- Percentile:
- D90
- Mean:
- < 3.76 µm
- St. dev.:
- 0.083
Any other information on results incl. tables
Under the microscope (with a magnification of 400) small, rod-shaped, partially agglomerated crystalline structures were observed.
A solubility test showed, that the test item is both sparingly soluble and well dispersed in water. Two dispersions were measured each in duplicate.
The results obtained during four measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.
ln conclusion using a laser diffraction apparatus to study the particle size in the range between 0.3 pm and 300 µm the mass median diameter (MMD) was determined to be 1.67 pm. The particle size distribution was found to range from approximately 0.5 to 8.0 µm.
Applicant's summary and conclusion
- Conclusions:
- MMD = 1.67 µm; range = 0.5 - 8.0 µm
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