Registration Dossier
Registration Dossier
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EC number: 220-006-9 | CAS number: 2601-33-4
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:
- Testing was conducted between 31 August 2005 and 18 October 2005.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- sieving
- Specific details on test material used for the study:
- Sponsor's identification: FSM-005W
Description: white solid
Batch number: 2005-01
Date received: 23 August 2005
Storage conditions: room temperature in the dark under nitrogen over silica gel
The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor. - Key result
- Percentile:
- other: 0.359%
- Mean:
- < 100 nm
- St. dev.:
- 0
- Remarks on result:
- other: Proportion of test material having an inhalable particle size less than 100 nm was 0.359% of the test material.
- No.:
- #1
- Size:
- < 100 nm
- Distribution:
- 0.359 %
- Conclusions:
- The result indicated that the test material was essentially non-inhalable.
- Executive summary:
Particle size data has been acquired using a procedure designed to comply with the European Commission technical guidance document 'Particle Size Distribution, Fibre Length and Diameter Distribution' (June 1996), which satisfies the requirements of OECD guideline 110. The results are as follows:
Measurement Method Result Proportion of test material having an inhalable particle size less than 100 gm Sieve 0.359% The result indicated that the test material was essentially non-inhalable.
Reference
Description of key information
Proportion of test material having an inhalable particle size less than 100 nm was 0.359%.
The result indicated that the test material was essentially non-inhalable.
Additional information
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