Registration Dossier

Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 January - 17 February 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern GLP study conform to CIPAC guidelines. No deviation from the guideline was reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 59 Sieve Analysis
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 170 Dry Sieve Analysis of Water Dispersible Granules
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 169 Tap Density of Water Disperse Granules
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of distribution:
mass based distribution

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch No. RW 2013-10-22
Expiry date 22 October 2018

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Any other information on results incl. tables

The tap density of the Yellow LF 6881 was found to be 0.80 g/ml.

Details are summarized in Table 1.

Table 1. Tap density determination

Sample mass (W):       80.3 g

Sample volume after dropping (V):       100 ml

Tap density (D):       0.80 g/ml

The particle size distribution of Yellow LF 6881 was found to be 45 µm, 1000 µm]. Details are summarized in Table 2.

Table 2. Sieve test

Number of sieves (n): 8

Sample mass (calculated): 128.5 g

Samples mass (m): 128.62 g

Sieve Size (µm) Serial No. Residue mass gx (g) Residue rx% Sum of residues Rx%

< 45 - 3.07 2.4 99.1

45 20111588 12.47 9.7 96.7

63 20111627 28.97 22.5 87.0

100 31121141 32.28 25.1 64.5

250 20111667 33.63 26.1 39.4

500 16111554 16.11 12.5 13.2

1000 20111725 0.87 0.7 0.7

2000 24111027 0.01 0.0 0.0

4000 14111099 0.00 0.0 0.0

Applicant's summary and conclusion

Conclusions:
The particle size distribution of Yellow LF 6881 was found to be: [45 µm, 1000 µm].
Executive summary:

Machine sieving test was carried out using the following test sieves4, 2, 1 mm, 500, 250, 100, 63 and 45 µm.

 

The particlesizedistribution ofYellow LF 6881was found to be:[45 µm, 1000 µm].

Categories Display