Registration Dossier
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EC number: 204-479-9 | CAS number: 121-54-0
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:
- January - February 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: BS3406, Part A, 1993
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- sieving
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
- Specific details on test material used for the study:
- TEST MATERIAL
- Identity: LZ1442.3, Benzethonium chloride
- Chemical name: Benzethonium chloride
- Appearance: White powder
- Storage conditions: Room temperature
- Stability under test conditions: stable for min. 3 years from manufacturing date
- Batch No.: OC0509
- Expiry date: 7 June2002
- Purity: Responsibility of sponsor
- Date received: 20 August 2001
- Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety. - Remarks on result:
- not determinable because of methodological limitations
- Percentile:
- D10
- Remarks on result:
- not measured/tested
- No.:
- #1
- Size:
- > 125 µm
- Distribution:
- 7.4 %
- No.:
- #2
- Size:
- > 105 µm
- Distribution:
- 0 %
- No.:
- #3
- Size:
- 60 - 105 µm
- Distribution:
- 18.3 %
- No.:
- #4
- Size:
- 30 - 60 µm
- Distribution:
- 41.7 %
- No.:
- #5
- Size:
- 10.4 - 30 µm
- Distribution:
- 30 %
- No.:
- #6
- Size:
- 0.5 - 10.4 µm
- Distribution:
- 2.7 %
- Conclusions:
- The results indicate that 2.7% by mass of Benzethonium chloride is smaller than 10 um.
- Executive summary:
The particle size distribution was initially examined using sieve analysis. As greater than 10% by weight of the test substance was found to pass a 75 micron sieve, it was further examined by image analysis based upon the procedure described in BS3406, Part A, 1993. The results indicate that 2.7% by mass of Benzethonium chloride is smaller than 10 um. The test item was observed to consist of irregular and semi transparent particles.
Reference
Description of key information
The particle size distribution was initially examined using sieve analysis. The results indicate that 2.7% by mass of Benzethonium chloride is smaller than 10 um. The test item was observed to consist of irregular and semi transparent particles.
Additional information
Source: GLP-report
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