Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 October 2016 to 12 November 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
< 0 g/L
Conc. based on:
test mat.
Incubation duration:
30 h
Temp.:
20 °C
pH:
> 5.8 - < 6.2
Remarks on result:
other: Less than 1.07 x 10^-5 g/L at 20.0 ± 0.5 °C
Details on results:
The Preliminary test: The preliminary estimate of water solubility at 20.0 ± 0.5 °C was less than 1.06 x 10-4 g/L. The solution had a pH of 6.1.

Definitive Test: The mean peak areas relating to the standard and sample solutions are shown in the following tables:
Solution = Mean Peak Area:
Standard 0.011 mg/L = 6.023 x 105
Standard 0.054 mg/L = 2.410 x 106
Standard 0.107 mg/L = 5.196 x 106
*Standard 0.529 mg/L = 3.848 x 107
Standard 0.537 mg/L = 1.859 x 107
Standard 1.07 mg/L = 3.546 x 107
Standard 2.68 mg/L = 7.131 x 107
Standard 5.37 mg/L = 1.128 x 108
Blank = none detected
Sample 1A = 3.1161 x 104
Sample 1B = 1.7466 x 104
Sample 2A = 1.6035 x 104
Sample 2B = 4.0564 x 103
Sample 3A = 1.6288 x 104
Sample 3B = 1.6321 x 104

Any other information on results incl. tables

Definitive Test

The concentration (g/L) of test item in the sample solutions at 20.0 ± 0.5 ºC are shown in the following table:

Sample Number Time Shaken at ~ 30 ºC (hours) Concentration (g/L) Solution pH
1 24 <1.07 x 10-5 6.2
2 48 <1.07 x 10-5 5.8
3 72 <1.07 x 10-5 5.8

Applicant's summary and conclusion

Conclusions:
The water solubility of the test item has been determined to be less than 1.07 x 10^-5 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:

The water solubility was less than 1.07 x 10^-5 g/L at 20.0 ± 0.5 °C using the flask method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.