Registration Dossier
Registration Dossier
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EC number: 939-648-2 | CAS number: 75081-73-1
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline compliant study with good documentation
- Qualifier:
- according to guideline
- Guideline:
- other: DIN 66165
- GLP compliance:
- no
- Type of method:
- sieving
- Type of distribution:
- other: diameter
- Percentile:
- D50
- Mean:
- 3 710 µm
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- No.:
- #1
- Size:
- < 125 µm
- Distribution:
- 2.9 %
- No.:
- #2
- Size:
- > 125 - <= 500 µm
- Distribution:
- 1 %
- No.:
- #3
- Size:
- > 500 - <= 1 000 µm
- Distribution:
- 1.1 %
- No.:
- #4
- Size:
- > 1 000 - 1 400 µm
- Distribution:
- 2.1 %
- No.:
- #5
- Size:
- > 1 400 - <= 2 000 µm
- Distribution:
- 6.9 %
- No.:
- #6
- Size:
- > 2 000 - <= 3 150 µm
- Distribution:
- 22.8 %
- No.:
- #7
- Size:
- > 3 150 - <= 4 000 µm
- Distribution:
- 20 %
- No.:
- #8
- Size:
- > 4 000 - <= 5 000 µm
- Distribution:
- 16.8 %
- No.:
- #9
- Size:
- > 5 000 µm
- Distribution:
- 26.3 %
- Executive summary:
In the non-GLP Klimisch 1 study from Bütfering (2012) the particle size distribution of the test item Butanedioic Acid, 2(or 3)-Sulfo-, 4-[2-[(1-Oxododecyl) amino] ethyl]ester, Disodium Salt was determined using the sieving method according to DIN 66165 with sieve sizes ranging from 125 to 5000 µm. The mass median diameter (MMD) of the test item was calculated to be 3710 µm.
This result is considered relevant and reliable for the risk assessment.
Reference
X10: 1649 µm
X50: 3710 µm
X90: > 5000 µm
Description of key information
mass median diameter (MMD): 3710 µm
Additional information
In the non-GLP Klimisch 1 study from Bütfering (2012) the particle size distribution of the test item Butanedioic Acid, 2(or 3)-Sulfo-, 4-[2-[(1-Oxododecyl) amino] ethyl]ester, Disodium Salt was determined using the sieving method according to DIN 66165 with sieve sizes ranging from 125 to 5000 µm. The mass median diameter (MMD) of the test item was calculated to be 3710 µm.
This result is considered relevant and reliable for the risk assessment.
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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