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:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
no
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
0.762 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.2

Any other information on results incl. tables

 

No.

Solution

Mass taken (g)

pH at

20

Peak area

Average value of peak areas

Factor ( f)

Average Value off

Mass concentration

(g/mL, 20)

1

STD1

0.02000 

/

48.546 

/

1.2145E+05

/

/

2

A

/

 

6.2

93.227 

93.352 

/

1.2022E+05

7.765E-04

 

 

 

 

 

 

 

3

93.476 

4

STD2

0.02480 

/

58.982 

/

1.1900E+05

/

/

5

B

/

 

6.2

93.314 

93.113 

/

1.2107E+05

7.691E-04

 

 

 

 

 

 

 

6

92.912 

7

STD1

0.02000 

/

49.226 

/

1.2315E+05

/

/

8

C

/

 

6.2

89.703 

89.664 

/

1.2121E+05

7.398E-04

 

 

 

 

 

 

 

9

89.625 

10

STD2

0.02480 

/

59.111 

/

1.1926E+05

/

/

The relative difference of the concentrations measured in the three flasks respectively: 

A-B1.0 % A-C4.8 % B-C3.9 %   

The concentrations measured in the three flasks do not differ by more than 15% each other, the test is satisfactory and the average value of all results can be calculated as the water solubility.

The last result of water solubility is the mean of the concentrations measured in the three flasks: [(7.765+7.691+7.398)×10-4/3] g/mL = 0.762 g/L, and pH = 6.2

Applicant's summary and conclusion

Conclusions:
0.762 g/L (20°C pH 6.2)