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Diss Factsheets

Physical & Chemical properties

Water solubility

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Administrative data

Link to relevant study record(s)

Reference
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

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.

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.

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.