Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
2009-08-17
Type of method:
flask method

Test material

Constituent 1
Reference substance name:
Montanov 14
IUPAC Name:
Montanov 14
Details on test material:
batch: T82925
storage: at room temperature, away from moisture and direct light
received: 2009-09-14

Results and discussion

Water solubility
Water solubility:
ca. 0.06 g/L
Temp.:
25 °C
pH:
ca. 5.9

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The solubility of the test item in water is :
6.043E-02 g/L in deionized water (pH 5.9) at 25 °C
The pH of the solution has no significant effect on the solubility.
Executive summary:

This study consisted in the determination of the solubility of one batch of MONTANOV 14 in water. This report presents the results of the determination of the solubility of the test item in water.

Reference and outline of the test method : The test procedure was based on “EEC method A6”/ OECD method 105

Preliminary test The principle of the preliminary test is as follows : The test item (approximately 0.1 g) is mixed at room temperature with increasing volumes of water (0.1 mL to 100 mL) ; the test solutions are equilibrated at the test temperature ; the solubility is estimated for each volume of water by checking visually for undissolved test item. Confirmation tests Flask method The test item is dissolved into water until saturation at a temperature slightly above the determination temperature. The mixture is cooled to and hold at the test temperature with stirring until a constant mass concentration is obtained.

Results are summarised in the table below :

Solvent Purified water
Solubility (g/L) after 24 hours presaturation 5.345E-02

Solubility (g/L) after 48 hours presaturation 6.750E-02

Solubility (g/L) after 72 hours presaturation 6.033E-02

Average solubility (g/L) 6.043E-02

The solubility of the test item in water is :

6.043E-02 g/L in deionized water (pH 5.9) at 25 °C

The pH of the solution has no significant effect on the solubility.