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Diss Factsheets
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EC number: 203-055-0 | CAS number: 102-79-4
- 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:
- 30 AUG 2021 to 13 JAN 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 27. Jul. 1995
- Deviations:
- yes
- Remarks:
- As the test item is very well soluble in water, it was not possible to weigh the fivefold saturation concentration of the test item in water in order to perform a main test as described in the guidelines.
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 24. Jan. 2014
- Deviations:
- yes
- Remarks:
- As the test item is very well soluble in water, it was not possible to weigh the fivefold saturation concentration of the test item in water in order to perform a main test as described in the guidelines.
- Qualifier:
- according to guideline
- Guideline:
- other: SANTE/2020/12830
- Version / remarks:
- 24. Feb. 2021
for the method validation - Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009 Rev.1 Corr. 2, Committee for Medicinal Products for Human Use (CHMP)
- Version / remarks:
- 21. Jul. 2011
for method validation - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Remarks on result:
- completely miscible
- Conclusions:
- The substance is completely miscible with water.
- Executive summary:
The water solubility of the test item was assessed during a GLP study according to OECD Guideline 105 and EU Method A.6.
The unlimited miscibility / solubility of N-Butyldiethanolamine in demineralised water was determined with the simplified flask method of the concentration range: 90.9 – 909.1 g test item / kg solution.
The solutions were shaken at room temperature for 10 minutes. Neither 2 phases nor a Tyndall effect were observed in the solutions.
The test item is therefore miscible with water without any restrictions, which is also shown by the HPLC measurement with a recovery of 99.5 - 104.6 % of the test item used.For the HPLC measurement a method was validated according to GLP, Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) and the Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009 Rev.1 Corr. 2, Committee for Medicinal Products for Human Use (CHMP).
All acceptance criteria defined in the study plan are fulfilled for the calibration range of 50 - 400 mg/L.
After the injection of the highest calibration level, a solvent blank was injected. The peak area of the detected signal in the blank fulfilled the condition “≤ 20 % of the measured value of the lowest calibration level”. The relative standard deviation of fivefold determination of 200 mg/L calibration level showed an RSD = 0.3 %.
All accuracy values lay in the demanded range of 70 – 120 %. As the mean value lay inside the range 100 ± 5 %, the mean recovery rate was not taken into account in the calculation of the test item concentrations during the determination of the water solubility.
The condition for precision “RSD ≤ 20 % per level” was fulfilled for both levels.
Reference
All acceptance criteria defined in the study plan are fulfilled for the calibration range of 50 - 400 mg/L.
After the injection of the highest calibration level, a solvent blank was injected. The peak area of the detected signal in the blank fulfilled the condition “≤ 20 % of the measured value of the lowest calibration level”. The relative standard deviation of fivefold determination of 200 mg/L calibration level showed an RSD = 0.3 %.
All accuracy values lay in the demanded range of 70 – 120 %. As the mean value lay inside the range 100 ± 5 %, the mean recovery rate was not taken into account in the calculation of the test item concentrations during the determination of the water solubility.
The condition for precision “RSD ≤ 20 % per level” was fulfilled for both levels.
The unlimited miscibility solubility of N-Butyldiethanolamine in demineralised water was determined with the simplified flask method of the concentration range: 90.9 – 909.1 g test item / kg solution.
The solutions were shaken at room temperature for 10 minutes. Neither 2 phases nor a Tyndall effect were observed in the solutions.
The test item is therefore miscible with water without any restrictions, which is also shown by the HPLC measurement with a recovery of 99.5 - 104.6 % of the test item used.
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.
Description of key information
OECD 105: unlimited miscibility solubility was determined with the simplified flask method of the concentration range: 90.9 – 909.1 g test item / kg solution; the substance was found to be completely miscible in water.
Key value for chemical safety assessment
- Water solubility:
- 10 000 mg/L
Additional information
The water solubility of the test item was assessed during a GLP study according to OECD Guideline 105 and EU Method A.6.
The unlimited miscibility / solubility of N-Butyldiethanolamine in demineralised water was determined with the simplified flask method of the concentration range: 90.9 – 909.1 g test item / kg solution.
The solutions were shaken at room temperature for 10 minutes. Neither 2 phases nor a Tyndall effect were observed in the solutions.
The test item is therefore miscible with water without any restrictions, which is also shown by the HPLC measurement with a recovery of 99.5 - 104.6 % of the test item used.
For the HPLC measurement a method was validated according to GLP, Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) and the Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009 Rev.1 Corr. 2, Committee for Medicinal Products for Human Use (CHMP).
All acceptance criteria defined in the study plan are fulfilled for the calibration range of 50 - 400 mg/L.
After the injection of the highest calibration level, a solvent blank was injected. The peak area of the detected signal in the blank fulfilled the condition “≤ 20 % of the measured value of the lowest calibration level”. The relative standard deviation of fivefold determination of 200 mg/L calibration level showed an RSD = 0.3 %.
All accuracy values lay in the demanded range of 70 – 120 %. As the mean value lay inside the range 100 ± 5 %, the mean recovery rate was not taken into account in the calculation of the test item concentrations during the determination of the water solubility.
The condition for precision “RSD ≤ 20 % per level” was fulfilled for both levels.
Conclusion: The substance is completely soluble (miscible) in water.
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