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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
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The study was conducted according to an internationally recognised method. No deviation was reported. Test substance is adequately specified. Therefore full validation applies.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of method:
- flask method
- Key result
- Water solubility:
- ca. 581 g/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 1 500 g/L
- Temp.:
- 30 °C
- pH:
- ca. 7
- Remarks on result:
- other: The water solubility of the substance was determined as 581 g/L at 30 ± 0.5°C (pH = 7). The conditions of the test were: a loading rate of 1500 ± 30 g/L and a water content of 4.2% w/w (dry matter result obtained on the powder).
- Conclusions:
- According to OECD method No. 105, the water solubility of the test item was determined as 581 g/L at 30 ± 0.5°C (pH=7), for a loading rate of 1500 ± 2 g/L and considering that the test item contains 4.2%w/w of water (dry matter result obtained on the powder).
- Executive summary:
A non-GLP study using flask method according to OECD method 105 and EU. A6 was conducted to determine the water solubility of the test item.
The water solubility ofthe test item was determined as 581 g/L at 30 ± 0.5°C (pH=7), for a loading rate of 1500 ± 2 g/L and considering that the test item contains 4.2% w/w of water (dry matter result obtained on the powder).
Reference
Results and discussion
1-Preliminary test
Solution |
Sample weight (g) |
Volume of water (mL) |
Concentration (g/L) |
Kathon®(drops) |
Initial pH |
Test temperature (°C) |
Mixing |
Final pH |
Visual appearance |
||||||||||
T1 |
6.4578 |
6 |
1076.3 |
5 |
7 |
21 |
10 minutes |
7 |
Small amount of undissolved powder |
Dissolution test T1 at 1076.3 g/L of test item in water revealed a low solubility. The powder is not fully solubilized.
Solution |
Sample weight (g) |
Volume of water (mL) |
Concentration (g/L) |
Kathon®(drops) |
Initial pH |
Test temperature (°C) |
Mixing |
Final pH |
Visual appearance |
Range of solubility (g/L) |
|||||||||||
T2 |
6.4578 |
30 |
215.3 |
5 |
7 |
21 |
10 minutes |
7 |
Clear and totally dissolved |
200-1000 |
Dissolution test T2 at 215.3 g/L revealed a very good solubility because the totality of test item was dissolved (visual control).
According to this preliminary OECD 105 test, the range of solubility of the test item in water is [200 g/L - 1000 g/L]at room temperature.
2-Flask method
a. Preparation of solutions
Based on conclusion of the first preliminary test, the solubility of the test item was determined to be between 200 and 1000 g/L. In order to saturate the test solution, OECD 105 recommends to prepare a solution whose concentration is 5 x 1000 g/L, i.e. 5000 g/L.
But at such concentration, the solution of test item is very viscous and has many lumps preventing any agitation. Therefore, for technical reasons, it was decided to progressively add mass of test item to a defined volume of water until the maximal saturation was reached according to a visual control.
The results are listed in the following table:
Volume of water (mL) |
Powder weight (g) |
Concentration (g/L) |
Visual appearance |
3 |
2.7309 |
900 |
Totally dissolved |
2.8852 |
950 |
||
3.0291 |
1000 |
Thickened solution |
|
3.1823 |
1050 |
||
3.3537 |
1100 |
||
3.5111 |
1150 |
||
3.6481 |
1200 |
||
3.7917 |
1250 |
Viscous solution - Mixing slow but regular Undissolved powder observed |
|
3.9401 |
1300 |
||
4.0929 |
1350 |
||
4.2652 |
1400 |
||
4.4237 |
1450 |
||
4.5889 |
1500 |
The maximal saturated concentration obtained by visual control was 1500 g/L at room temperature. This loading rate will be considered for the main test.
Three flasks were prepared at a loading rate close to 1500 g/L for equilibration for 24, 48 and 72 hours at 30 ± 0.5°C.
|
Solution |
Sample weight (g) |
Water (mL) |
Saturated concentration (g/L) |
Initial pH |
Temperature (°C) |
Mixing |
Equilibration |
Final pH |
Visual appearance |
Centrifugation |
|
|||||||||||
TEST |
T1 |
4.5885 |
3 |
1529.5 |
7 |
30 |
24h |
24h |
7 |
Brown orange |
4000 rpm 10 minutes |
T2 |
4.4306 |
3 |
1476.9 |
7 |
30 |
24h |
48h |
7 |
Brown orange |
4000 rpm 10 minutes |
|
T3 |
4.5117 |
3 |
1503.9 |
7 |
30 |
24h |
72h |
7 |
Brown orange |
4000 rpm 10 minutes |
The observations made during for the three equilibration times were similar.
b. Determination of the dry matter content of saturated solutions
The concentration of the test item dissolved in water was determined using dry matter assay method RD-ANA-MSG-I-047.
Three drying times in a 105°C oven were tested on test item at 1010.15 g/L in duplicate: 7, 24 and 48 hours.
|
0h |
7h |
24h |
48h |
|||||||
Replicas |
Tare weight (g) |
Full weight (g) |
Dry weight (g) |
DM content (g/L) |
Mean DM of powder (mg/g) |
Dry weight (g) |
DM content (g/L) |
Mean DM of powder (mg/g) |
Dry weight (g) |
DM content (g/L) |
Mean DM of powder(mg/g) |
a |
12,5631 |
15,6959 |
14,0921 |
488,06 |
488,46 |
14,0739 |
482,25 |
482,23 |
14,0675 |
480,21 |
480,13 |
b |
12,7285 |
16,0538 |
14,3541 |
488,86 |
14,3320 |
482,21 |
14,3248 |
480,05 |
The results for the drying times between 7h and 48h were similar (RSD = 1.8 %) and so it was decided to use the drying time of 7 hours.
Solutions were analyzed in duplicate and the results are listed in the following table:
|
Solution |
Replicas |
Tare weight (g) |
Full weight (g) |
Dry weight 7 h (g) |
DM content 7 h (g/L) |
Mean DMTSi (1) (g/L) |
Uncertainty (g/L) (2) |
Amplitude (g/L) (3) |
Compliant (Y/N) (4) |
Mean (DMmean) (5) (g/L) |
Uncertainty (g/L) (6) |
Amplitude (g/L) (7) |
Compliant (Y/N) (8) |
TEST |
T1 |
a |
11.3229 |
13.8714 |
12.7440 |
557.6 |
557.2 |
23.4 |
0.8 |
O |
556.8 |
27.6 |
3.3 |
Y |
b |
11.9698 |
15.1246 |
13.7263 |
556.8 |
O |
|||||||||
T2 |
a |
13.0471 |
16.2521 |
14.8993 |
559.2 |
558.3 |
23.4 |
1.8 |
O |
|||||
b |
12.6081 |
15.4279 |
14.1799 |
557.4 |
O |
|||||||||
T3 |
a |
11.7086 |
14.5683 |
13.2941 |
554.4 |
555.0 |
23.3 |
1.1 |
O |
|||||
b |
13.1147 |
15.9040 |
14.6641 |
555.5 |
O |
The three dry matter contents determined (DMT1, DMT2and DMT3) did not differ by more than 15%, (RSD = 0.3 %) and so the results are validated according to OECD method No. 105.
The dry matter content of saturated solutions of test item was 557 g/L at 30 ± 0.5 °C (pH = 7) for a loading rate of approximately 1500 +/- 30 g/L (without correction of water contained in the test item).
a. Determination of the water contentof the test product
The dry matter content of the powder was assayed in order to determine the water content .
Three drying times in a 105°C oven were tested: 24, 40 and 48 hours.
|
0h |
24h |
40h |
48h |
|||||||
Replicas |
Tare weight (g) |
Full weight (g) |
Dry weight (g) |
DM content (g/L) |
Mean DM of powder (mg/g) |
Dry weight (g) |
DM content (g/L) |
Mean DM of powder (mg/g) |
Dry weight (g) |
DM content (g/L) |
Mean DM of powder(mg/g) |
a |
50,0290 |
51,0543 |
51,0135 |
960,21 |
960,03 |
51,0124 |
959,13 |
958,34 |
51,0122 |
958,94 |
957,84 |
b |
44,9651 |
45,9591 |
45,9192 |
959,86 |
45,9169 |
957,55 |
45,9161 |
956,74 |
The results between 24 and 48 hours were similar (RSD = 0.1%) and so it was decided to use the powder of dried for40 hours.
Samples were analyzed in duplicate and the results are listed in the following table:
|
Replicas |
Tare weight (g) |
Full weight (g) |
Sample weight at 40 h (g) |
DM content at 40 h (mg/g) |
Mean DM of powder (9) (mg/g) |
Uncertainty (mg/g) (10) |
Amplitude (mg/g) (11) |
Compliant (Y/N) (12) |
Water content (13) (%) |
Mean water content (%) Cwater mean (14) |
Sample |
a |
50.0290 |
51.0543 |
51.0124 |
959.1 |
958.3 |
40.2 |
1.6 |
Y |
4.1 |
4.2 |
b |
44.9651 |
45.9591 |
45.9169 |
957.5 |
Y |
4.3 |
The water content of the test item powder was 4.2% w/w, in compliance with the result reported in the Certificate of analyses provided in attachment.
Determination of water solubility of the test product
With:
Mean dry matter: DMmean(g/L) |
Mean water content: Cwater mean (%) |
Water solubility (g/L) at 30 ± 0.5°C (pH = 7), for a loading rate of 1500 ± 30 g/L and considering that the test item contains 4.2% w/w of water |
557 |
4.2 |
581 |
Description of key information
The water solubility of test item was determined as 581 g/L at 30 ± 0.5°C (pH = 7).
Key value for chemical safety assessment
- Water solubility:
- 581 g/L
- at the temperature of:
- 30 °C
Additional information
A non-GLP study using flask method according to OECD method 105 and EU. A6 was conducted to determine the water solubility of the test item.
The water solubility of the test item was determined as 581 g/L at 30 ± 0.5°C (pH=7), for a loading rate of 1500 ± 2 g/L and considering that the test item contains 4.2%w/w of water (dry matter result obtained on the powder).
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