Registration Dossier
Registration Dossier
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EC number: 273-105-4 | CAS number: 68937-98-4 This substance is identified by SDA Substance Name: C14-C18 and C12-C20 unsaturated alkyl alkene and C14-C18 and C12-C20 unsaturated alkyl hydroxy sulfonic acid sodium salt and SDA Reporting Number: 03-059-04.
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 December 2017 - 25 January 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002).
- Version / remarks:
- European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- cascade impaction
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
- Remarks on result:
- not determinable
- Remarks on result:
- not measured/tested
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- ca. 87.5 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- ca. 6.4 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- ca. 2.31 %
- Conclusions:
- Percentage of test item with an inhalable particle size <100 μm: 87.5%
Percentage of test item with a thoracic particle size <10.0 μm: 6.40%
Percentage of test item with a thoracic particle size <5.5 μm: 2.31%
Reference
Description of key information
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Additional information
A particle size distribution determination was conducted as part of a package of physicochemical testing on Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts (Envigo Research Limited, 2018, Study GT32WD). The study was conducted in compliance with GLP and the particle size distribution determination was performed according to procedure designed to be compatible with European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).
Mean cumulative percentage with a particle size less than 100.0 μm: 87.50
Mean cumulative percentage with a particle size less than 10.0 μm: 6.40
Mean cumulative percentage with a particle size less than 5.5 μm: 2.31
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