Registration Dossier
Registration Dossier
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EC number: 232-468-9 | CAS number: 8049-47-6
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-02-06 to 2017-02-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 (Particle Size Analysis by Laser Diffraction)
- Deviations:
- no
- 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:
- Pancreatin
- EC Number:
- 232-468-9
- EC Name:
- Pancreatin
- Cas Number:
- 8049-47-6
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Pancreatin
- Reference substance name:
- Lipids as a constituent of Pancreatin derived from porcine pancreas
- IUPAC Name:
- Lipids as a constituent of Pancreatin derived from porcine pancreas
- Reference substance name:
- Inorganic Salts as a constituent of Pancreatin derived from porcine pancreas
- IUPAC Name:
- Inorganic Salts as a constituent of Pancreatin derived from porcine pancreas
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Unidentified impurities
- IUPAC Name:
- Unknown impurities
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and Not available
- Expiration date of the lot/batch: 2017-12-22
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature, dry
Results and discussion
- Mass median aerodynamic diameter:
- ca. 603.1 µm
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- ca. 110.6 µm
- St. dev.:
- 0.8
- Key result
- Percentile:
- D50
- Mean:
- ca. 603.1 µm
- St. dev.:
- 2.4
- Key result
- Percentile:
- D90
- Mean:
- ca. 1 183.9 µm
- St. dev.:
- 0.2
Applicant's summary and conclusion
- Conclusions:
- The test item's particle size distribution was determined by laser diffraction measurement according to OECD Test Guideline 110 (1981), ISO 13320 (2009) and EPA OCSPP Guideline 830.7520 (1996).
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.
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