N,N'-methylenedistearamide

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 Jun 2018 to 12 Sep 2018

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 July 1995

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Key result

Water solubility:

< 0 g/L

Temp.:

20 °C

pH:

6.5

The concentration (mg/L) of test item in the sample solutions is shown in the following table:

Sample number	Time shaken at ~ 30 ºC (hours)	Concentration* (mg/L)	Mean Concentration (mg/L)	Solution pH
1A	24	1.20 x 10^-3	1.74 x 10^-3	6.5
1B	24	2.29 x 10^-3
2A	48	9.37 x 10^-4	7.24 x 10^-4	6.5
2B	48	5.12 x 10^-4
3A	72	2.22 x 10^-3	3.32 x 10^-3	6.5
3B	72	4.41 x 10^-3

*Calculated concentrations have not been corrected for matrix blank.

- Overall result: Less than 1 x 10^-2 mg/L (1 x 10-5 g /L) at 20.0 ± 0.5^oC

- Limit of detection: 2 x 10^-3 mg/L

- Limit of quantification: 1 x 10^-2 mg/L

DISCUSSION

The water solubility was determined to be below 1E-02 g/L in the preliminary test, the flask method was preferred to the column elution method due to the insolubility of the test item in suitable organic solvents to coat the glass beads required for the test. On completion of the equilibration period, the samples were clear colorless liquids with excess test item present. The solutions were filtered leaving a clear colorless solution with no excess test item visible. No Tyndall beam effect was observed in the solutions. The limit of detection (LOD) was assessed as three times the matrix blank, calculated to be 2E-03 mg/L (using dilution factor of 0.005). The limit of quantification (LOQ) was assessed as the lowest validated level (1E-02 mg/L). Due to the relatively high response for the matrix blank and some variation in the sample concentrations, the overall result has been reported as a limit value based on the limit of quantification.

Conclusions:

The water solubility of the test item has been determined to be less than 1.0E-5 g/L of solution at 20.0 ± 0.5 ºC.

Executive summary:

The water solubility was determined in pH 6.5 at 20.0 °C using the flask method designed to be compatible with OECD TG 105 and in compliance with GLP. It was found that the water solubility of pure substance at 20 °C is less than 1.0E-5 g/L of solution at 20.0 ± 0.5 ºC and pH 6.5.

Description of key information

water solubility < 1.0E-5 g/L at 20 °C, compatible with OECD 105, flask method, Butler 2018