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Physical & Chemical properties

Water solubility

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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From November 2, 2020 to November 16, 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
It was not possible to prepare the test item solutions at the saturation level recommended in the guideline.
GLP compliance:
yes
Type of method:
flask method

Test material

Constituent 1
Reference substance name:
Sulfonic acids, C16-alkane hydroxy and C16-alkene, sodium salts
EC Number:
297-664-9
EC Name:
Sulfonic acids, C16-alkane hydroxy and C16-alkene, sodium salts
Cas Number:
93686-15-8
IUPAC Name:
Sulfonic acid, C16-alkane hydroxy and C16-alkene, sodium salts
Test material form:
solid
Remarks:
This solid sample was obtained from the original liquid form by removing water.
Details on test material:
CAS number: 93686-15-8
Specific details on test material used for the study:
-Storage conditions
The test sample was sealed with nitrogen gas and stored with silica gel in a dark storage place at room temperature.

-Test item identification and stability under storage conditions
The infrared (IR) spectrum of the test item measured at this test facility was confirmed to be identical to that provided by the sponsor.
In addition, the IR spectrum of the test item after the completion of the experiment was the same as that before the start of the experiment, and it indicated that the test item was stable under the storage conditions.

Results and discussion

Water solubility
Key result
Water solubility:
>= 35 - < 38 other: % w/w
Conc. based on:
act. ingr.
Incubation duration:
24 h
Temp.:
20 °C
pH:
ca. 10.3

Any other information on results incl. tables





























Sample description



Test concentration (% w/w)



Observations



Solution pH



Test solution-1



33.0



Test solution was a clear, viscous, pale yellow solution.  The test sample was completely dissolved.



10.4



Test solution-2



35.0



Test solution was a clear, viscous, pale yellow solution.  The test sample was completely dissolved.



10.3



Test solution-3



38.0



Test solution was an opaque, pale yellow viscous liquid.  The test sample was not completely dissolved.



Not applicable


Applicant's summary and conclusion

Conclusions:
The water solubility of the registered substance was determined to be 35.0 to 38.0% w/w at 20ºC.
Executive summary:

-Objective


The objective of this study is to obtain the water solubility of C16IOS-Na.


 


-Test guideline


OECD Guidelines for Testing of Chemicals, No. 105, July 27, 1995, "Water Solubility: Flask method"


 


-Test conditions


Test concentration: 33.0, 35.0 and 38.0% w/w


Test water: Purified water (Takasugi Pharmaceutical, The Japanese Pharmacopoeia)


Agitation temperature: 30ºC


Agitation period: 3 days


Test temperature: 20±0.5ºC


Equilibration time: 24 hours


Number of repetition: 1 (at each test concentration)


 


-Results


The water solubility of the registered substance was determined to be 35.0 to 38.0% w/w at 20ºC.