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EC number: 282-001-8 | CAS number: 84082-55-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lupinus albus, Leguminosae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 7 April 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to an internationally recognised method, and under GLP. The test substance is adequately characterised. Therefore, full validation applies.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 13320-1:1999
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: NFX11-507 (1989)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP certificate (inspected on 22 and 23 December 2014/signed on 28 July 2015)
- Type of method:
- sieving
- Type of distribution:
- mass based distribution
- Key result
- Percentile:
- D50
- Mean:
- ca. 130 µm
- Remarks on result:
- other: 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Conclusions:
- After the preliminary test, it was shown that the majority of the particles (77.4%) was between a size of 1 mm and 100 µm. 22.5% of the particles has a size lower than 100 µm.
After the main test, it was shown that the particle size distribution of the test item was found to range approximately between 25 µm to 500 µm and only 11.5% are lower than 90 µm. 76.7% of the test item has got a size between 100 µm and 500 µm. The median diameter was calculated at 130 µm. - Executive summary:
The particle size distribution of the test substance was determined under GLP according to the Guideline OECD No. 110 (1981), ISO 13320-1:2009 and NFX11-507 (1989).
After the preliminary test, it was shown that the majority of the particles (77.4%) was between a size of 1 mm and 100 μm. 22.5% of the particles has a size lower than 100 μm.
After the main test, it was shown that the particle size distribution of the test item was found to range approximately between 25 μm to 500 μm and only 11.5% are lower than 90 μm. 76.7% of the test item has got a size between 100 μm and 500 μm. The median diameter was calculated at 130 μm.
Reference
Results
Preliminary sieving
Ambient humidity About 34%
Temperature About 22 °C
Mass of test item used 50.07 g
Table 4.5.2
Test sieve |
25 mm |
4 mm |
1 mm |
0.1 mm |
Collecting pan (<0.1 mm) |
Total mass after sieving (g) |
Mass of residue(g) |
/ |
/ |
0.00 |
38.75* |
11.27 |
50.02 |
Percentage of residue (%) |
/ |
/ |
0.0 |
77.4 |
22.5 |
|
Time of mechanical sieving (min) |
/ |
/ |
30 |
30 |
30 |
|
Time of manual sieving (min) |
/ |
/ |
1 |
6 |
/ |
|
The loss of test item was 0.1%.
Remark: The particles size was visibly lower than 1 mm. So, the sieves of 25 mm and 4 mm were not used.
*The distribution of the test item has shown that the major part of the test item was retained by the 100-μm sieve. In this case, the maximal volume of the test item which can be retained by the sieve (46 cm3) was reached, knowing that the density of the test item was determined at 0.689 g/cm3 during the study No. 16-919076-002.
So as to have a representative particle size distribution, a minimum quantity of about 50 g of the test item was necessary even if this quantity is higher than the quantity prescribed by the guideline.
The maximal volumes of the material which can be retained of sieves indicated in the Table No. 4.5.1 is given to have an optimal sieving. With a higher charge of product retained on the sieve, the complete surface is occupied and some particles with a lower size can be blocked by particles retained on the sieve with a higher size. As a mechanical and a manual sieving is done, this situation does not exist. It may exist when the sieve is static. The quantity of the particles between the collecting pan (<0.1 mm) and the sieve of 1 mm is higher than 20% of the charge. So, the principal sieving was made with sieves with mesh sizes lower than 1 mm.
Principal sieving
From 710 μm to 125 μm
Ambient humidity About 33%
Temperature About 22 °C
Mass of test item used 38.45 g (from the preliminary sieving) corresponding
to 76.8% of the initial mass of the test item
Table No. 4.5.3
Test sieve |
710 µm |
500 µm |
355 µm |
250 µm |
180 µm |
125 µm |
Collecting pan |
Total mass after sieving (g) |
Particles size (µm) |
>710 |
500-710 |
355-500 |
250-355 |
180-250 |
125-180 |
100-125 |
/ |
Mass of residue (g) |
0.00 |
0.02 |
0.11 |
1.09 |
7.78 |
17.74 |
11.71 |
38.45 |
Percentage of residue (% w/w) related to the initial mass used (50.07 g) |
0.0 |
0.0 |
0.2 |
2.2 |
15.5 |
35.4 |
23.4 |
|
Cumulated undersized particles (% w/w of the substance < Test sieve) |
100.0 |
100.0 |
99.7 |
97.6 |
82.0 |
46.6 |
23.2 |
|
Time of mechanical sieving (min) |
30 |
30 |
30 |
30 |
30 |
30 |
/ |
|
Time of manual sieving (min) |
1 |
1 |
2 |
2 |
7 |
13 |
/ |
|
No loss of mass was recorded.After sieving, the maximal volume of the test item which can be retained by each sieve was not reached.
From 90 μm to 20 μm
Ambient humidity About 30%
Temperature About 22 °C
Mass of test item used 11.23 g (from the preliminary sieving) corresponding
to 22.4% of the initial mass of the test item
Table No. 4.5.4
Test sieve |
90 µm |
63 µm |
45 µm |
32 µm |
25 µm |
20 µm |
Collecting pan |
Total mass after sieving(g) |
Particles size (µm) |
90-100 |
63-90 |
45-63 |
32-45 |
25-32 |
20-25 |
<20 |
/ |
Mass of residue (g) |
5.32 |
4.77 |
0.76 |
0.20 |
0.05 |
0.00 |
0.00 |
11.10 |
Percentage of residue (% w/w) related to the initial mass used (50.07 g) |
10.6 |
9.5 |
1.5 |
0.4 |
0.1 |
0.0 |
0.0 |
|
Cumulated undersized particles (% w/w of the substance < Test sieve) |
11.5 |
2.0 |
0.5 |
0.1 |
0.0 |
0.0 |
0.0 |
|
Time of mechanical sieving (min) |
30 |
30 |
30 |
30 |
30 |
30 |
/ |
|
Time of manual sieving (min) |
7 |
5 |
3 |
2 |
1 |
/ |
/ |
|
A loss of mass of about 1.2%was observed, which may be due to the loss of material during the handling of the substance and the thickness of the particles. After sieving, the maximal volume of the test item which can be retained by each sieve was not reached.
Summary of the particle size distribution
Particles size (µm) |
>710 |
500-710 |
355-500 |
250-355 |
180-250 |
125-180 |
100-125 |
90-100 |
63-90 |
45-63 |
32-45 |
25-32 |
20-25 |
<20 |
Mass of residue(g) |
0.00 |
0.02 |
0.11 |
1.09 |
7.78 |
17.74 |
11.71 |
5.32 |
4.77 |
0.76 |
0.20 |
0.05 |
0.00 |
0.00 |
Percentage of residue(%w/w) |
0.0 |
0.0 |
0.2 |
2.2 |
15.5 |
35.4 |
23.4 |
10.6 |
9.5 |
1.5 |
0.4 |
0.1 |
0.0 |
0.0 |
Conclusion
After the preliminary test, it was shown that the majority of the particles (77.4%) was between a size of 1 mm and 100 µm. 22.5% of the particles has a size lower than 100 µm.
After the main test, it was shown thatthe particle size distribution of the test item was found to range approximately between 25 µm to 500 µm and only 11.5% are lower than 90 µm. 76.7% of the test item has got a size between 100 µm and 500 µm.
The median diameter was calculated at 130 µm.
Description of key information
The median diameter was calculated at 130 μm.
Additional information
After the preliminary test, it was shown that the majority of the particles (77.4%) was between a size of 1 mm and 100 μm. 22.5% of the particles has a size lower than 100 μm. After the main test, it was shown that the particle size distribution of the test item was found to range approximately between 25 μm to 500 μm and only 11.5% are lower than 90 μm. 76.7% of the test item has got a size between 100 μm and 500 μm. The median diameter was calculated at 130 μm.
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