Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-180-7 | CAS number: 80875-98-5
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August to october 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- cascade impaction
- Type of particle tested:
- agglomerate
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- (2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid
- EC Number:
- 617-180-7
- Cas Number:
- 80875-98-5
- Molecular formula:
- C9 H15 N O2
- IUPAC Name:
- (2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- Cream to white powder
Constituent 1
Results and discussion
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- ca. 13.3 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- <= 2.25 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- <= 0.14 %
Applicant's summary and conclusion
- Conclusions:
- Particle size data acquired for the test item is shown in the following table:
Measurement Method Result
Percentage of test item with an inhalable particle size <100 μm Sieve 13.3%
Percentage of test item with a thoracic particle size <10.0 μm Cascade Impactor ≤ 2.25%
Percentage of test item with a respirable particle size <5.5 μm Cascade Impactor ≤0.14% - Executive summary:
Particle size data was acquired using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002). The results are as follows:
Measurement Method Result
Proportion of test item having an inhalable particle size <100 μm Sieve 13.3%
Proportion of test item having a thoracic particle size <10.0 μm Cascade Impactor ≤ 2.25%
Proportion of test item having a respirable particle size <5.5 μm Cascade Impactor ≤0.14%
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
