D-glucitol monolaurate

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 Nov 2017 - 04 Apr 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

27th July 1995

Deviations:

yes

Remarks:

Due to the difficulty in separating the dispersed and suspended sample material (an oily suspension) from the aqueous fraction, a modified method was adopted. See "Any other information on materials and methods incl. tables"

GLP compliance:

no

Type of method:

flask method

Test material

Test material information

Constituent 1

Reference substance name:

D-glucitol monolaurate

EC Number:

247-888-8

EC Name:

D-glucitol monolaurate

Cas Number:

26657-97-6

Molecular formula:

C18H36O7

IUPAC Name:

1-O-dodecanoyl-D-glucitol

Results and discussion

Water solubility

Key result

Water solubility:

21.75 mg/L

Conc. based on:

test mat.

Loading of aqueous phase:

50 mg/L

Temp.:

20 °C

Remarks on result:

other: pH was not reported.

Any other information on results incl. tables

 

Alternative test samples	Loading mass (g)	Temperature (°C)	Mean Carbon detected (mg/L)	Carbon Content (%)	Concentration of samples (mg/L)
1	0.05	20.2	11.32	50	21.23
2	0.05	20.2	12.30	50	23.19
3	0.05	20.2	11.12	50	20.83
Average	0.05	20.2	--	--	21.75
Standard deviation					1.263
%RSD					5.807

 

The sample appeared to melt at approximately 30 °C so attempts to assess the temperature dependence of solubility were complicated by the nature of the test material. However extensive experimentation conducted during this study gives no reason to anticipate temperature dependence as defined in the protocol. Increases in temperature readily produces an oily layer of the material on the surface of the water, agitation produces foaming but no other interaction from the test material.

 

The sample appears chemically stable in water with no evidence of chemical reaction. Samples from the preliminary test stored for the duration of the testing period showed no evidence of chemical reactions.

 

The carbon content of the test item was calculated as 50%. Calculations were based on compositional information provided by the sponsor.

 

 

Discussion

All specified validity criteria were satisfied in this test, the difference in the measured concentration of the samples were <15% (RSD = 5.807%).

No temperature dependence or chemical instability of the material was observed during this study.

The water solubility of the test item was found to be 21.75 mg/L at 20 °C using the modified flask method.