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EC number: 812-241-6 | CAS number: -
- 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:
- March 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. 484 g/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 1 158 g/L
- Temp.:
- 30 °C
- pH:
- ca. 5
- Remarks on result:
- other: the water solubility of OF14 AT was determined as 484 g/L at 30 ± 0.5°C (pH=5), for a loading rate of 1158 ± 2 g/L and considering that the test item contains 3.5%w/w of water (dry matter result obtained on the powder).
- Conclusions:
- According to OECD method No. 105, the water solubility of OF14 AT was determined as 484 g/L at 30 ± 0.5°C (pH=5), for a loading rate of 1158 ± 2 g/L and considering that the test item contains 3.5%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 OF14 AT.
The water solubility of OF14 AT was determined as 484 g/L at 30 ± 0.5°C (pH=5), for a loading rate of 1158 ± 2 g/L and considering that the test item contains 3.5%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 |
6.0500 |
6 |
1008.33 |
5 |
/ |
21 |
10 minutes |
/ |
Viscous – undissolved powder |
Dissolution test T1 at 1008.33 g/L of OF14 AT in water revealed very low solubility. The test solution was viscous and the powder was 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) |
|||||||||||
E2 |
6.0500 |
30 |
201.67 |
5 |
5 |
21 |
10 minutes |
5 |
Clear and totally dissolved |
200-1000 |
Dissolution test T2 at 201.67 g/L revealed good solubility because the totality of OF14 AT was dissolved (visual control).
According to this preliminary OECD 105 test, the range of solubility of OF14 AT in water was [200 g/L - 1000 g/L] at room temperature.
2- Flask method
Based on conclusion of the first preliminary test, the solubility of OF14 AT was determined to be between 200 and 1000 g/L. In order to saturate the test solution, a solution should be prepared whose concentration is 5 x 1000 g/L, i.e. 5000 g/L.
But during the preliminary test, it was found undissolved powder at a concentration of 1000 g/l. The maximal saturated concentration should be around 1000 g/l.
It was decided to progressively add mass of test item to a defined volume of water until “maximal saturation was reached according to a visual control. This pre-test was performed at room temperature.
The resultsare listed in the following table:
Volume of water (ml) |
Powder weight (g)) |
Concentration (g/L) |
Visual appearance |
10 |
6,5 |
650 |
Powder fully solubilized |
7,0 |
700 |
||
7,5 |
750 |
Suspension powder then dissolved after a few minutes of stirring |
|
8,0 |
800 |
||
8,5 |
850 |
||
9,0 |
900 |
||
9,5 |
950 |
||
10,0 |
1000 |
||
10,5 |
1050 |
||
11,0 |
1100 |
Powder in suspension |
|
11,5 |
1150 |
Formation of lumps |
The “maximal saturated” concentration obtained by visual control in this pre-test was1100 g/L at room temperature.[BC3] This loading rate will be considered for the main test.
Three flasks were preparedat a loading rate of about 1100g/L for equilibration for 24, 48 and 72 hours at 30 ± 0.5°C.
|
Solution |
Sample weight (g) |
Water (mL) |
“Saturated concentration” (g/L) = loading rate |
Initial pH |
Temperature (± 0.5°C) |
Mixing |
Equilibration (occasional shaking made morning and evening) |
Final pH |
Visual appearance |
Centrifugation |
|
|||||||||||
TEST |
T1 |
11,5668 |
10 |
1156,7 |
5 |
30 |
24h |
24h |
5 |
Clear yellow |
4000 rpm 10 minutes |
T2 |
11,5929 |
10 |
1159,3 |
5 |
30 |
24h |
48h |
5 |
Clear yellow |
4000 rpm 10 minutes |
|
T3 |
11,5653 |
10 |
1156,5 |
5 |
30 |
24h |
72h |
5 |
Clear yellow |
4000 rpm 10 minutes |
The three tests yielded similar results and so the study could be continued.
Determination of the dry matter content (DM)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 in duplicate: 7, 24 and 48 hours.
|
0h |
7h |
24h |
48h |
|||||||
Replicas |
Tare weight (g) |
Full weight (g) |
Sample weight (g) |
DM content (mg/g) |
Mean DM of powder (mg/g) |
Sample weight (g) |
DM content (mg/g) |
Mean DM of powder (mg/g) |
Sample weight (g) |
DM content (mg/g) |
Mean DM of powder (mg/g) |
a |
12,1520 |
15,2566 |
13,6626 |
486,57 |
486,22 |
13,6291 |
475,78 |
475,73 |
13,6058 |
468,27 |
468,06 |
b |
12,1682 |
15,3083 |
13,6939 |
485,88 |
13,6619 |
475,69 |
13,6373 |
467,85 |
The results for the drying times between 7h and 48h were similar (RSD=1.9%) and so it was decided to use the drying time of 24 hours.
Solutions were analyzed in duplicate and the results were listed in the following table:
|
Solution |
Replicas |
Tare weight (g) |
Full weight (g) |
Dry weight 24 h (g) |
DM content 24 h (g/L) |
Mean DMTi (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 |
12.0664 |
15.9321 |
13.8399 |
458.8 |
459.9 |
19.3 |
2.2 |
Y |
467.3 |
23.1 |
12.3 |
Y |
b |
12.8604 |
16.4737 |
14.5260 |
461.0 |
Y |
|||||||||
T2 |
a |
13.0698 |
16.8876 |
14.8682 |
471.1 |
469.7 |
19.7 |
2.7 |
Y |
|||||
b |
12.3710 |
15.6635 |
13.9133 |
468.4 |
Y |
|||||||||
T3 |
a |
11.7756 |
14.7921 |
13.1812 |
466.0 |
472.2 |
19.8 |
12.4 |
Y |
|||||
b |
12.1521 |
15.7050 |
13.8518 |
478.4 |
Y |
The results from vessels 1, 2 and 3 show a tendency of increasing values. However, the three dry matter contents determined (DMT1, DMT2and DMT3) did not differ by more than 15%, (RSD=1.39%) and so the results were validated according to OECD method No. 105.
The dry matter content of saturated solutions of OF14 AT was 467 g/L at 30 ± 0.5 °C (pH 5) for a loading rate of approximately 1158 +/- 2g/L (without correction of water contained in OF14 AT
Determination of the water content of the test product
The dry matter content of the powder was assayed in order to determine the water content of OF14 AT.
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) |
Sample weight (g) |
DM content (mg/g) |
Mean DM of powder (mg/g) |
Sample weight (g) |
DM content (mg/g) |
Mean DM of powder (mg/g) |
Sample weight (g) |
DM content (mg/g) |
Mean DM of powder (mg/g) |
a |
44,9655 |
45,8862 |
45,8445 |
954,71 |
955,20 |
45,8439 |
954,06 |
953,4 |
45,8435 |
953,62 |
952,93 |
b |
44,8850 |
45,9547 |
45,9073 |
955,69 |
45,9042 |
952,79 |
45,9036 |
952,23 |
The results at 24, 40 and 48 hours were similar (RSD = 0.13%) and so it was decided to use the powder of dried for40 hours.
OF14 AT samples were analyzed in duplicate and the results were 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) (%w/w) |
Mean water content (%w/w) Cwater mean (14) |
Sample |
a |
45.1363 |
46.2242 |
46.1846 |
963.6 |
964.9 |
40,5 |
2.7 |
Y |
3.6 |
3.5 |
b |
44.7146 |
45.6547 |
45.623 |
966.3 |
Y |
3.4 |
The water content of OF14 AT powder was 3.5%w/w, in compliance with the result reported in the Certificate of analyses provided in attachment.
Determination of water solubilityof 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=5), for a loading rate of 1158 ± 2 g/L and considering that the test item contains 3.5%w/w of water
|
467 |
3.5 |
483.9 |
Description of key information
The water solubility of OF14 AT was determined as 484 g/L at 30 ± 0.5°C (pH=5).
Key value for chemical safety assessment
- Water solubility:
- 484 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 OF14 AT.
The water solubility of OF14 AT was determined as 484 g/L at 30 ± 0.5°C (pH=5), for a loading rate of 1158 ± 2 g/L and considering that the test item contains 3.5%w/w of water (dry matter result obtained on the powder).
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