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EC number: 293-214-0 | CAS number: 91052-53-8
- 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:
- 5 oct. 2017 to 15 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- column elution method
- Specific details on test material used for the study:
- Name (or product trading name) * Glycerides, C12-18, Mono-, Di- and Tri-
FCBA reference 17/1162F/1
Batch number * 170519013326
Manufacturing date * May 15, 2017
Composition* Certificate of analysis: see Annex 1 (non GLP data)
Active substance [CAS number] * Glycerides, C12-18 Mono-, Di- and Tri- [61789-05-7]
Purity * 100 % commercial product
Manufacturer * SEPPIC
Test item state Wax
Test item quantity received at test facility 50 g
Packaging 1 plastic flask
Storage conditions * 20 ± 5°C
Stability : deadline to use* Expiry date: May 15, 2019 - Key result
- Water solubility:
- ca. 17.2 mg/L
- Conc. based on:
- test mat. (dissolved fraction)
- Incubation duration:
- ca. 10 min
- Temp.:
- 20 °C
- pH:
- >= 6 - <= 7
- Details on results:
- Preliminary estimation:
A weight of 0.1 g of test item was shaken at room temperature with increasing volumes of water in a stepwise manner. After each addition of an amount of water, the mixture was shaken for 10 minutes and the dissolution was assessed visually In order to estimate the solubility of the test item. At the request of the sponsor, additional evaluations were performed. A weight of 0.01 g and 0.005 g of the test item were shaken with 1000 mL and 5000 mL of water respectively.
Test temperature: 19.8 °C
Taking the visual observations into account, the preliminary test shows that the solubility of the test item was comprised between 10 g/L and 50 g/L.
The solubility estimated of test item “Glycerides, C12-18, Mono-, Di- and Tri-” in water at ambient temperature was comprised between 10 g/L and 50 g/L, thus flask method was selected for the main test.
Further to the preliminary testing and on the composition of the test item, the expected solubility in water is of the order a few mg/L and no g/L. Microscopic observations allowed to show the presence of fine colloid structures and insoluble structure. Based on these considerations, the sponsor requested to perform the elution column method in order to determine the water solubility of the test item “Glycerides, C12-18, Mono-, Di- and Tri-”.
Results definitive test:
During the first experiment (25 mL/h), the water solubility was determined using the mean of the five last sample, the water solubility has been determined to be 13.1 ± 2.6 mg/L.
The maximum of difference observed on the five last sample is: 14.74 -10.76 = 3.98 mg/L.
The mean of the two maximum value is (14.74+10.76)/2 = 12.75 mg/L. The relative difference, corresponding to the ratio of the maximum difference and the mean of the two maximum values is: (3.98/12.75)* 100 =31.2%.
During the experiment at 25 mL/h, the relative difference was slightly higher than the criteria more than ± 30 %: 31.2 % Considering the fact that the preparation to analyse the test item is a complex preparation of analytic samples (i.e. methylation) and that the quantification is performed on the sum areas of five peaks, this result can be considered as valid and which equilibrium was established.
During the second experiment (12.5 mL/h), the water solubility was determined using the mean of the six last sample, the water solubility has been determined to be 21.3 ± 2.9 mg/L.
The maximum of difference observed on the six last sample is: 24.52 -18.29 = 6.23 mg/L.
The mean of the two maximum value is (18.29+24.52)/2 = 21.41 mg/L. The relative difference, corresponding to the ratio of the maximum difference and the mean of the two maximum values is: (6.23/21.41)* 100 = 29.1%.
The six last sample concentration do not differ more than ± 30 % which means that equilibrium was established.
Deviation between the averages obtained for both experiments:
The difference observed on the two means calculated for both experiments is: 21.3 – 13.1 = 8.2 mg/L.
The mean of the two means is (21.3+13.1)/2 = 17.2 mg/L. The relative difference, corresponding to the ratio of the difference and the mean of the two means calculated for both experiments is: (8.2/17.2)* 100 = 47.7%.
The mean value obtained from two experiments differed by more than 30% (47.7%). At view of the complexity to analyse the test item due to a complex preparation analytic samples (i.e. methylation), a mixture of compounds and the behavior of each compounds in water which quantified on the sum areas, this deviation of 47.7% seems to be high in view of criteria of 30 % but nevertheless, the means obtained at 25 mL/h and 12.5 mL/h are relatively close (21.3 mg/L and 13.1 mg/L). In that case, these results can be considered as acceptable and valid. In conclusion, the water solubility of the test item “Glycerides, C12-18, Mono-, Di- and Tri-” was determined to be 17.2 mg/L. This value is the mean of two independent measurements at 25 mL/h and 12.5 mL/h. - Conclusions:
- The water solubility of the test item “Glycerides, C12-18, Mono-, Di- and Tri-” was determined to be 17.2 mg/L. This value is the mean of two independent measurements at 25 mL/h and 12.5 mL/h.
- Executive summary:
The aim of this study wasto determine experimentally the water solubilityon the test item“Glycerides C12-18, Mono-, Di- and Tri-”according to the OECD 105 guideline.
The study was carried out in accordance with the study plan No.17/1162F/b-e dated October 04, 2017.
There was three deviations and no amendment during this study.
The results of this study are summarized below:
Two independent experiments were carried out. Concentration of the test item was regularly measured by GC/FID (Gas chromatography with Flame Ionization Detector).
The water solubility of the test item“Glycerides C12-18, Mono-, Di- and Tri-”was determined to be 17.2 mg/L.
Reference
Validation criteria
Results obtained for the Quality Control (QC) were compared to the acceptance criteria:
Date of analysis |
Sample ID |
Nominal value |
Measured value (mg/L) |
Deviation (%) |
Conformity +/- 15 % / nominal value |
March 07, 2018 |
QC 25 mg/L 8/230218/9 QC01 to QC02 |
25 mg/L |
23.39 |
- 6.4 |
Yes |
23.57 |
- 5.7 |
Date of analysis |
Sample ID |
Nominal value |
Measured value (mg/L) |
Deviation (%) |
Conformity +/- 15 % / nominal value |
March 08, 2018 |
QC 25 mg/L 8/230218/9 QC01 to QC02 |
25 mg/L |
23.99 |
- 4.0 |
Yes |
23.98 |
- 4.1 |
Results obtained for the Unknown Standards were compared to the acceptance criteria:
Date of analysis |
Sample ID |
Nominal value |
Measured value (mg/L) |
Deviation (%) |
Conformity +/- 15 % / nominal value |
March 07, 2018 |
VF 25 mg/L 8/230218/4 VF01 to VF02 |
25 mg/L |
24.29 |
- 2.8 |
Yes |
24.21 |
- 3.2 |
Date of analysis |
Sample ID |
Nominal value |
Measured value (mg/L) |
Deviation (%) |
Conformity +/- 15 % / nominal value |
March 08, 2018 |
VF 25 mg/L 8/230218/4 VF01 to VF02 |
25 mg/L |
25.16 |
+ 0.6 |
Yes |
24.61 |
- 1.6 |
The unknown standards and the Quality controls (QCs) are well within 21.25 mg/L and 28.75 mg/L
Conclusion
The water solubility of the test item “Glycerides, C12-18, Mono-, Di- and Tri-” was determined to be 17.2 mg/L. This value is the mean of two independent measurements at 25 mL/h and 12.5 mL/h.
Description of key information
The water solubility of the test item “Glycerides C12-18, Mono-, Di- and Tri-”was determined to be 17.2 mg/L.
Key value for chemical safety assessment
- Water solubility:
- 17.2 mg/L
- at the temperature of:
- 20 °C
Additional information
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