Registration Dossier

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:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
Minor deviations were noted but these did not have an impact on the overall study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
A method has been proposed by Thomas and Burosse to improve the current OECD 105 Water Solubility test design for poorly water soluble liquids by incorporating a portion of another OECD guideline (OECD 123) This method is very similar to a previous method used by Varaprath et al to determine the solubility of several poorly soluble permethylsiloxanes. The test article was anticipated to be so poorly soluble, that the current methods listed in OECD 105 are inappropriate.
Deviations:
yes
Remarks:
Minor deviations were noted but these did not have an impact on the overall study
Principles of method if other than guideline:
A method has been proposed by Thomas and Burosse to improve the current OECD 105 Water Solubility test design for poorly water soluble liquids by incorporating a portion of another OECD guideline (OECD 123) This method is very similar to a previous method used by Varaprath et al to determine the solubility of several poorly soluble permethylsiloxanes. The test article was anticipated to be so poorly soluble, that the current methods listed in OECD 105 are inappropriate.
GLP compliance:
yes
Type of method:
other: This method is very similar to a previous method used by Varaprath et al to determine the solubility of several poorly soluble permethylsiloxanes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Key result
Water solubility:
< 7.17 other: ng/g
Conc. based on:
test mat.
Remarks on result:
not determinable because of methodological limitations
Remarks:
The solubility of the test article in water is less than the method detection limit of 7.17 ng/g.
Details on results:
The aqueous solubility of HES 10108 was investigated in accordance with EPA (TSCA) Good Laboratory Practices 40 CFR Part 792. Test vessels were setup similar to the slow stirring method (OECD 123) to account for anticipated poor water solubility. Water samples were concentrated using solid phase extraction and analyzed by GC-FID. The aqueous solubility was found to be less than the method detection limit of 7.17 ng/g.

Applicant's summary and conclusion

Conclusions:
The aqueous solubility of HES 10108 was investigated in accordance with EPA (TSCA) Good Laboratory Practices 40 CFR Part 792. Test vessels were setup similar to the slow stirring method (OECD 123) to account for anticipated poor water solubility. Water samples were concentrated using solid phase extraction and analyzed by GC-FID. The aqueous solubility was found to be less than the method detection limit of 7.17 ng/g.
Executive summary:

The objective of this study was to experimentally determine the aqueous solubility of HESlO108. The study was conducted in accordance with EPA (TSCA) Good Laboratory Practices 40 CFR Part 792. Test vessels were setup similar to the slow stirring method (OECD 123)3 to account for anticipated poor water solubility. Water samples were concentrated using solid phase extraction and analyzed by GC-FID. The aqueous solubility was found to be less than the method detection limit in matrix of 7.17 ng/g.