Registration Dossier
Registration Dossier
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EC number: 260-686-4 | CAS number: 57345-19-4
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 08, 2017
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a: Endpoint specific guidance, Version 5.0, December 2016
- Deviations:
- no
- GLP compliance:
- no
- Type of method:
- sieving
Test material
- Reference substance name:
- rel-(3S,5aR,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Molecular formula:
- C18H30O2
- IUPAC Name:
- rel-(3S,5aR,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Reference substance name:
- rel-(3R,5aS,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Cas Number:
- 220432-47-3
- Molecular formula:
- C18H30O2
- IUPAC Name:
- rel-(3R,5aS,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Lot No.:VE00484383
Purity:99.8 % (major peak)
Expiration date:August 23, 2017
Results and discussion
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- 0.8 %
- No.:
- #2
- Size:
- < 100 µm
- Distribution:
- 0.9 %
- No.:
- #3
- Size:
- < 100 µm
- Distribution:
- 0.8 %
Any other information on results incl. tables
The results of the tested samples are represented in the following table:
Sample |
1 |
2 |
3 |
Total sample weight |
10.00 g |
10.00 g |
10.00 g |
Weight of particles < 100µm |
0.08 g |
0.09 g |
0.08 |
Weight-% of particles < 100µm |
0.8% |
0.9% |
0.8% |
Applicant's summary and conclusion
- Conclusions:
- The tested sample of Amberketal contains virtually no particles with a particle size of <100 µm. According to the integrated testing strategy for granulometry, as outlined in Figure R.7.1-6 of the above-mentioned guidance document, further testing is therefore not necessary.
- Executive summary:
As suggested in the integrated testing strategy for granulometry, outlined in Figure R.7.1-6 of the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a: Endpoint specific guidance, Version 5.0, December 2016, the granulometry of Amberketal was assessed by sieving through a sieve with 100µm aperture width.
In three independent trials the weight percentage of particles with a particle size of <100µm was 0.8%, 0.9% and 0.8%, respectively.
It was therefore concluded that the tested sample of Amberketal contains virtually no particles with a particle size of <100µm. According to the integrated testing strategy for granulometry, as outlined in Figure R.7.1-6 of the above-mentioned guidance document, further testing is therefore not necessary.
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