Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28 July, 2017 to 05 September, 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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Appearance: Colorless liquid
- Purity: 97.5%
- Lot number: 6K0001

Results and discussion

Water solubility
Key result
Water solubility:
3.08 mg/L
Temp.:
20 °C
pH:
>= 5.9 - <= 6.1
Details on results:
Flow rate: 0.4 mL/min
-Watar solubility measurement value: 2.94 - 3.34 mg/L
-Watar solubility average 3.10 mg/L
-Standard deviation 0.154
-pH 6.0 - 6.1

Flow rate: 0.2 mL/min
-Watar solubility measurement value 2.79 - 3.45 mg/L
-Watar solubility average 3.07 mg/L
-Standard deviation 0.256
-pH 5.9 - 6.1

Average of all watar solubility value: 3.08 mg/L
Maximum difference (%): 19.1

Any other information on results incl. tables

Confirmation of equilibrium state

-The concentration of test item in the elutiong fraction was measured three times after the test water was flowed at 0.4 mL/min through the column for measurement of water solubility.  It was judged from the folloing results that the concentration had reached equilibirium after 13.8 hours.

Sampling time 13.8 hour     concentration 3.44 mg/L

Sampling time 15.8 hour     concentration 3.02 mg/L

Sampling time 17.8 hour     concentration 3.05 mg/L

Applicant's summary and conclusion

Conclusions:
The water solubility value of the test item at 20°C is 3.08 mg/L.
Executive summary:

It was judged that the test results were valid because the maximum dirrerence of concentration was less than 30%.