Reaction mass of N,N'-ethylenebis[N-methyl-2-[(1-oxo-9-octadecenyl)oxy]-N-[2-[(1-oxo-9-octadecenyl)oxy]propyl]propylammonium] dimethyl disulphate and [2-[bis(2-hydroxypropyl)amino]ethyl]bis(2-hydroxypropyl)(methyl)ammonium methyl sulphate, dioleate (ester)

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01.02.2018 - 30.07.2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 181

GLP compliance:

no

Type of method:

flask method

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of N,N'-ethylenebis[N-methyl-2-[(1-oxo-9-octadecenyl)oxy]-N-[2-[(1-oxo-9-octadecenyl)oxy]propyl]propylammonium] dimethyl disulphate and [2-[bis(2-hydroxypropyl)amino]ethyl]bis(2-hydroxypropyl)(methyl)ammonium methyl sulphate, dioleate (ester)

EC Number:

916-222-4

Molecular formula:

C51H99N2O6.CH3O4S

IUPAC Name:

Reaction mass of N,N'-ethylenebis[N-methyl-2-[(1-oxo-9-octadecenyl)oxy]-N-[2-[(1-oxo-9-octadecenyl)oxy]propyl]propylammonium] dimethyl disulphate and [2-[bis(2-hydroxypropyl)amino]ethyl]bis(2-hydroxypropyl)(methyl)ammonium methyl sulphate, dioleate (ester)

Results and discussion

Water solubility

Key result

Water solubility:

< 10 mg/L

Conc. based on:

test mat.

Loading of aqueous phase:

10 g/L

Incubation duration:

10 min

Temp.:

20 °C

pH:

ca. 7.8

Applicant's summary and conclusion

Conclusions:

The solubility of the test item, AGENT 5088-127A was found to be ˂ 10 g/L at 20 ± 1°C, as determined in accordance with CIPAC Method MT 181.

Executive summary:

Preliminary Test - As per CIPAC Method MT 181

The preliminary test was performed as perCIPAC MT 181 (CIPAC,1998),to determine the approximate solubility of the test item and based on the results of the preliminary test, the approximate weight of the test item was selected for the definitive test was decided.

About 0.1 g of test item was weighed in triplicate in to separate 10 mL glass stoppered measuring cylinders. Then, 0.5 mL of double distilled water was added to each measuring cylinders followed by incremental addition of
0.5 mL, 0.5 mL,1.0 mL and up to 10.0mL. After addition of each aliquot of double distilled water, the cylinders were stoppered, shaken vigorously and stored in an incubator maintained at 20 ± 1°C (maximum and minimum temperatures were 20.2°C and 19.8°C, respectively) for 10 min with intermittent shaking. After 10 min of storage at 20 ± 1°C, the measuring cylinders were taken out and the contents of the cylinders were visually checked for presence of any un-dissolved test item before making the next addition of solvent.

The approximate solubility of test item in double distilled water was recorded as given below:

Solvent	Repli-cation	Weight of test item (g)	Total Volume of Double Distilled Water added (mL)	Approximate Solubility At 20 ± 1°C (g/L)
Double distilled water	R1	0.1006	10.0	<10
	R2	0.1002
	R3	0.1001

After addition of 10 mL of double distilled water,the test item remained insoluble in 10 mL of double distilled water andthe solubility was recorded as <10 g/L and the definitive test was not carried out.