Registration Dossier

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:
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:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to
Guideline:
other: CIPAC MT 157
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
Batch number: 78-242-15

Results and discussion

Water solubility
Water solubility:
1.45 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.3
Details on results:
For all the sample solutions the pH value was 6.3, measured by pH meter.
The quality criteria of the A.6 method were verified (RSD% over three values is < 15%).

Any other information on results incl. tables

Internal

code

As

mean of 2 readings.

Cs (1)

(mg/mL)

Ds

WaterSolubility

(mg/L)

WS A1

0.428275

14.46

100

1.446

WS A2

0.43024

14.52

100

1.452

WS B1

0.42844

14.46

100

1.446

WS B2

0.42867

14.47

100

1.447

WS C1

0.426265

14.39

100

1.439

WS C2

0.430555

14.53

100

1.453

Mean value :

1.45

Standard deviation (S.D.) :

0.005

Relative Standard Deviation (RSD%) :

0.36%

Applicant's summary and conclusion

Conclusions:
The water solubility of the test item is 1.45 mg/l at 20°C