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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 21 September 2017 to 24 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
Adopted by the Council on 27th July 1995
GLP compliance:
yes (incl. QA statement)
Remarks:
Dates of inspection: 14-15 February 2017, Date of the certificate: 30 June 2017
Type of method:
flask method
Key result
Water solubility:
0.388 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
1 000 mg/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 6.7 - <= 7

Solubility in HPLC water at 20°C +/- 0.5°C

 Time pH   Cmeas. (ng/mL)  Ccalc. (mg/L)  Cmean (mg/L)  SD (mg/L)
 24h     7.0     19.8  0.396  0.388                 0.003               
 19.3  0.386
 48h     6.7     19.4  0.388
 19.2  0.384
 72h     6.7     19.6  0.392
 19.0  0.380

Results of the Method Validation

 Specificity  Interfering components conform to less than 20% of the LOQ criteria
 Repeatability (7 injections)  2.63%
 Dynamic range  15 - 60 ng/mL   
 Limit of Quantification  15 ng/mL
 Recovery and Precision      
 Concentration (mg/L)  *0.1  *1.0
 Recovery (%)  97.5  104.4
 Precision (%)  2.42  1.60
 Stability of calibration sample in autosampler for 3h 54 min (%)  103.3

* The test solutions were prepared in methanol-HPLC water mixtures.

Conclusions:
The solubility of Fluorosulfonic Adduct is 0.388±0.003 mg/L in HPLC water at 20°C+/-0.5°C.
Executive summary:

The determination of the water solubility of the test item, Fluorosulfonic Adduct, was carried out under GLP compliance, using the flask method according to OECD Guideline No. 105.

Test samples were prepared with 100 mL ultrapure water and approx. 100 mg test item. They were kept and mixed (on a magnetic stirrer) between 29.2 – 31.9°C for 24, 48 and 72 hours. After the incubation the flasks were transferred and equilibrated between 19.92 – 20.08°C for additional 24 hours (no was mixing applied during the equilibration). After equilibration, test samples werre filtered and diluted with Diluent 20 fold for the measurement (A calibration curve was prepared and ranged from 15 to 75 ng/mL.)

Each sample was prepared in duplicate.

The solubility of Fluorosulfonic Adduct is 0.388±0.003 mg/L in HPLC water at 20°C+/-0.5°C.

Description of key information

The solubility of Fluorosulfonic Adduct is 0.388±0.003 mg/L in HPLC water at 20°C+/-0.5°C.

Key value for chemical safety assessment

Water solubility:
0.388 mg/L
at the temperature of:
20 °C

Additional information

The determination of the water solubility of the test item, Fluorosulfonic Adduct, was carried out under GLP compliance, using the flask method according to OECD Guideline No. 105.

A calibration curve was prepared and ranged from 15 to 75 ng/mL. Test samples were prepared with 100 mL ultrapure water and approx. 100 mg test item. They were kept and mixed (on a magnetic stirrer) between 29.2 – 31.9°C for 24, 48 and 72 hours. After the incubation the flasks were transferred and equilibrated between 19.92 – 20.08°C for additional 24 hours (no was mixing applied during the equilibration). After equilibration, test samples werre filtered and diluted with Diluent 20 fold for the measurement. Each sample was prepared in duplicate.

The solubility of Fluorosulfonic Adduct is 0.388±0.003 mg/L in HPLC water at 20°C+/-0.5°C.