Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2nd, 2014 to April 22nd, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Principles of method if other than guideline:
The samples were not centrifuged after sampling. As the test mixture replicates were stirred not turbulent, this centrifugation step was not deemed necessary.
GLP compliance:
yes (incl. certificate)
Type of method:
flask method
Remarks:
with slow stirring approach at 20 ± 0.5 °C.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Specific details on test material used for the study:
Test material name (as stated in the report): Cetonal
Batch No.: SC00011028
Expiry date: 23 June, 2016

Results and discussion

Water solubility
Key result
Water solubility:
4.63 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
7

Applicant's summary and conclusion

Conclusions:
The water solubility of CETONAL was determined to be: 4.63 mg/L (20 °C, pH 7) in the test conditions.
Executive summary:

The water solubility of CETONAL (batch: SC00011028) was determined according to OECD guideline 105 (1995) and Council Regulation (EC) No. 440/2008, Method A.6 from 2015-04-17 to 2015-04-22 at Dr.U.Noack-Laboratorien, 31157 Sarstedt, Germany.

The solubility of the test item in double distilled water was determined employing the flask method with slow stirring approach at 20 ± 0.5 °C.

The analytical method (UPLC-MS/MS, external standard) for the determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity. The water solubility of CETONAL was determined to be: 4.63 mg/L (20 °C, pH 7)