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EC number: - | 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 14 September 2015 - 13 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- An OECD 105 GLP study for a similar substance is available and is used within a read-across approach. The composition of source and target substance is described and discussed in detail in the attached supporting information as well as the read-across justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certificate attached to study report
- Other quality assurance:
- ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Target substance:
Amidoamine 2 (UVCB, low nitrogen):
Former chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
CAS No.: 1618093-67-6
New chemical name: Glycerides, C16-18 (even numbered) and their amidation products with diethylenetriamine
Physical state: pale yellowish solid at 20 °C
Batch No.: PU50070067
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions - Key result
- Water solubility:
- < 0.01 mg/L
- Temp.:
- 20 °C
- pH:
- > 11
- Details on results:
- The concentration of test item in the sample solutions was determined by liquid chromatography – mass spectroscopy (LC-MS).
- Conclusions:
- Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility was determined to be less than 1.02 x 10-5 g/L at 20.0 ± 0.5 °C.
It is considered likely, that the target substance Amidoamine 2 (UVCB, low nitrogen) will have a comparable Water solubility (< 1 mg/l) as Amidoamine (UVCB) based on the similar chemical composition. - Executive summary:
In the GLP Klimisch 1 key study, the water solubility of amidoamine test item was determined according to OECD 105 and EU method A.6. The water solubility was determined to be less than 1.02 x 10-5 g/L at 20.0 ± 0.5 °C. It is considered likely, that the target substance Amidoamine 2 (UVCB, low nitrogen) will have a comparable Water solubility (< 1 mg/l) as Amidoamine (UVCB) based on the similar chemical composition. It is expected that the higher concentration of saturated mono- and diglycerides and the presence of saturated triglycerides in Amidoamine 2 (UVCB, low nitrogen) will not significantly influence the water solubility with regard to the risk assessment.
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 September 2015 - 13 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certificate attached to study report
- Other quality assurance:
- ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Test item without emulsifier was investigated.
Source substance:
Amidoamine (UVCB)
Pulcra ID: DE07_2014_012_BEL66 (amidoamine without emulsifier)
Former chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
Former CAS No.: 1618093-67-6
New chemical name: Triglycerides, C16-18 (even-numbered), reaction products with diethylenetriamine
Physical state: pale yellowish solid at 20 °C
Batch No.: K8 4309 L481
Expiry date of batch: 09 March 2018
Purity: 100 % (UVCB)
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light
Target substance:
Amidoamine 2 (UVCB, low nitrogen):
Former chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
CAS No.: 1618093-67-6
New chemical name: Glycerides, C16-18 (even numbered) and their amidation products with diethylenetriamine
Physical state: pale yellowish solid at 20 °C
Batch No.: PU50070067
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions - Key result
- Water solubility:
- < 0.01 mg/L
- Temp.:
- 20 °C
- pH:
- > 11
- Details on results:
- The concentration of test item in the sample solutions was determined by liquid chromatography – mass spectroscopy (LC-MS).
- Conclusions:
- Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility was determined to be less than 1.02 x 10-5 g/L at 20.0 ± 0.5 °C. - Executive summary:
In the GLP Klimisch 1 key study, the water solubility of amidoamine test item was determined according to OECD 105 and EU method A.6. The water solubility was determined to be less than 1.02 x 10-5 g/L at 20.0 ± 0.5 °C.
Referenceopen allclose all
A preliminary test was performed in order to select the appropriate method and to determine the approximate amount of test item to be used in the main test.
An aliquot of ground test item (0.10 g) was added to 500 mL of purified water. After shaking at 30 °C for 24 hours and standing at 20 °C for at least 24 hrs, the mixture was filtered through a 0.45 µm filter to provide a clear supernatant free from excess undissolved test item. An aliquot of the supernatant (100 mL), adjusted to pH > 11 using sodium hydroxide, was passed through a Strata X (100 mg, 6 mL) solid phase extraction (SPE) cartridge, and the test item eluted using 1 mL of methanol/tetrahydrofuran/formic acid (80/20/0.1 v/v/v). The eluate was analysed using the conditions detailed below.
After preparation, the samples were shaken at approximately 30 °C for 24¾, 48 and 72 hours After standing at 20 °C for a period of at least 24 hours, the contents of the flasks were filtered through a 0.45 µm filter to provide a clear supernatant free from excess undissolved test item. The pH of each sample solution was measured.
The concentration of test item in the sample solutions was determined by liquid chromatography – mass spectroscopy (LC-MS).
In duplicate, an aliquot of the supernatant (100 mL), was passed through the SPE cartridge and dried under vacuum for approximately 10 minutes and further dried using nitrogen for approximately 25 minutes. The analyte was eluted using methanol/tetrahydrofuran/formic acid (80/20/0.1 v/v/v, [mobile phase B]) into a 1 mL volumetric flask and vialled for analysis.
Calibration standard solutions of test item were prepared in methanol/tetrahydrofuran/formic acid (80/20/0.1 v/v/v, [mobile phase B]) in the nominal concentration range of 0.1 to 1.5 mg/L.
Matrix Blank was Methanol/tetrahydrofuran/formic acid (80/20/0.1 v/v/v).
The standard, blank and sample solutions were analyzed by LC-MS using the following conditions:
HPLC System : Agilent Technologies 1100 Series
Detector type : Mass selective (MS)
Column : Zorbax Eclipse SB-C3 5µm (250 x 4.6 mm id)
Column temperature : 30 °C
Mobile phase : Mobile phase A: Methanol:water:formic acid 50/50/0.1 v/v/v
Mobile phase B : Methanol:THF:formic acid 80/20/0.1 v/v/v
Flow-rate : 1.0 mL/min
Injection volume : 25 µL
Time (mins) | % A | % B |
0 | 99.9 | 0.1 |
7 | 0.1 | 99.9 |
11 | 0.1 | 99.9 |
11.5 | 99.9 | 0.1 |
15 | 99.9 | 0.1 |
MS detector parameters:
Mode: SIM
Mass (m/z)*: 580 (diamide of diethylenetriamine and palmitic acid), 608 (diamide of diethylenetriamine and palmitic and stearic acid), 636 (diamide of diethylenetriamine and stearic acid) - chosen as key components representing > 50 % of the amidoamine test item.
Fragment voltage: 325 V
Polarity: positive
Nebuliser Pressure: 25 psi
Capillary Voltage: 5000
Drying Gas Flow: 6 L/min
Drying Gas Temperature: 275 °C
Retention time : Approximately 9.3 to 9.6 minutes (3 peaks)
The mean peak area and concentration of each standard were plotted on a calibration curve. The concentration of the sample solutions (mg/L) was interpolated from this curve and was corrected for dilution factor (0.01) and a recovery correction factor (1.74).
Sample number | Time shaken at 30 °C (hours) | Time equilibrated at 20°C (hours) | Mean concentration corrected for recovery (g/L) | Solution pH |
1 | 24.75 | 24.75 | 6.93 x 10-4 | 5.9 |
2 | 48 | 24.75 | 8.62 x 10-4 | 5.9 |
3 | 72 | 24.75 | 7.03 x 10-4 | 6.1 |
The limit of detection for the analysis was defined as the concentration of the lowest acceptable calibration standard, corrected for recovery, 1.83 x 10-3 mg/L (1.83 x 10-6 g/L).
A preliminary test was performed in order to select the appropriate method and to determine the approximate amount of test item to be used in the main test.
An aliquot of ground test item (0.10 g) was added to 500 mL of purified water. After shaking at 30 °C for 24 hours and standing at 20 °C for at least 24 hrs, the mixture was filtered through a 0.45 µm filter to provide a clear supernatant free from excess undissolved test item. An aliquot of the supernatant (100 mL), adjusted to pH > 11 using sodium hydroxide, was passed through a Strata X (100 mg, 6 mL) solid phase extraction (SPE) cartridge, and the test item eluted using 1 mL of methanol/tetrahydrofuran/formic acid (80/20/0.1 v/v/v). The eluate was analysed using the conditions detailed below.
After preparation, the samples were shaken at approximately 30 °C for 24¾, 48 and 72 hours After standing at 20 °C for a period of at least 24 hours, the contents of the flasks were filtered through a 0.45 µm filter to provide a clear supernatant free from excess undissolved test item. The pH of each sample solution was measured.
The concentration of test item in the sample solutions was determined by liquid chromatography – mass spectroscopy (LC-MS).
In duplicate, an aliquot of the supernatant (100 mL), was passed through the SPE cartridge and dried under vacuum for approximately 10 minutes and further dried using nitrogen for approximately 25 minutes. The analyte was eluted using methanol/tetrahydrofuran/formic acid (80/20/0.1 v/v/v, [mobile phase B]) into a 1 mL volumetric flask and vialled for analysis.
Calibration standard solutions of test item were prepared in methanol/tetrahydrofuran/formic acid (80/20/0.1 v/v/v, [mobile phase B]) in the nominal concentration range of 0.1 to 1.5 mg/L.
Matrix Blank was Methanol/tetrahydrofuran/formic acid (80/20/0.1 v/v/v).
The standard, blank and sample solutions were analyzed by LC-MS using the following conditions:
HPLC System : Agilent Technologies 1100 Series
Detector type : Mass selective (MS)
Column : Zorbax Eclipse SB-C3 5µm (250 x 4.6 mm id)
Column temperature : 30 °C
Mobile phase : Mobile phase A: Methanol:water:formic acid 50/50/0.1 v/v/v
Mobile phase B : Methanol:THF:formic acid 80/20/0.1 v/v/v
Flow-rate : 1.0 mL/min
Injection volume : 25 µL
Time (mins) | % A | % B |
0 | 99.9 | 0.1 |
7 | 0.1 | 99.9 |
11 | 0.1 | 99.9 |
11.5 | 99.9 | 0.1 |
15 | 99.9 | 0.1 |
MS detector parameters:
Mode: SIM
Mass (m/z)*: 580 (diamide of diethylenetriamine and palmitic acid), 608 (diamide of diethylenetriamine and palmitic and stearic acid), 636 (diamide of diethylenetriamine and stearic acid) - chosen as key components representing > 50 % of the amidoamine test item.
Fragment voltage: 325 V
Polarity: positive
Nebuliser Pressure: 25 psi
Capillary Voltage: 5000
Drying Gas Flow: 6 L/min
Drying Gas Temperature: 275 °C
Retention time : Approximately 9.3 to 9.6 minutes (3 peaks)
The mean peak area and concentration of each standard were plotted on a calibration curve. The concentration of the sample solutions (mg/L) was interpolated from this curve and was corrected for dilution factor (0.01) and a recovery correction factor (1.74).
Sample number | Time shaken at 30 °C (hours) | Time equilibrated at 20°C (hours) | Mean concentration corrected for recovery (g/L) | Solution pH |
1 | 24.75 | 24.75 | 6.93 x 10-4 | 5.9 |
2 | 48 | 24.75 | 8.62 x 10-4 | 5.9 |
3 | 72 | 24.75 | 7.03 x 10-4 | 6.1 |
The limit of detection for the analysis was defined as the concentration of the lowest acceptable calibration standard, corrected for recovery, 1.83 x 10-3 mg/L (1.83 x 10-6 g/L).
Description of key information
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility was determined to be less than 1.02 x 10-5 g/L at 20.0 ± 0.5 °C.
It is considered likely, that the target substance Amidoamine 2 (UVCB, low nitrogen) will have a comparable Water solubility (< 1 mg/l) as Amidoamine (UVCB) based on the similar chemical composition. It is expected that the higher concentration of saturated mono- and diglycerides and the presence of saturated triglycerides in Amidoamine 2 (UVCB, low nitrogen) will not significantly influence the water solubility with regard to the risk assessment.
Key value for chemical safety assessment
- Water solubility:
- 0 g/L
- at the temperature of:
- 20 °C
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.