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Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-02-06 to 2003-02-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Version / remarks:
EG-guideline 92/69
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
EC Number:
249-616-3
EC Name:
Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
Cas Number:
29420-49-3
Molecular formula:
C4HF9O3S.K
IUPAC Name:
potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate
Specific details on test material used for the study:
Source and lot/batch No.of test material: K100
- Expiration date of the lot/batch: August 12, 2004
- Purity: 98.7%
- Purity test date:August 12, 2002
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: Day 0 and day 5.
Buffers:
- Composition of buffer:
pH 4:: citric acid / potassium hydroxide / sodium chloride;
pH 7: potassium dihydrogen phosphate / Di-sodium hydrogen phosphate;
pH 9: borax / hydrochloric acid;
Duration of testopen allclose all
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
98.3 other: %
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
98.2 other: %
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
98.1 other: %
Positive controls:
not specified
Negative controls:
not specified

Results and discussion

Transformation products:
not measured
Dissipation DT50 of parent compoundopen allclose all
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Type:
(pseudo-)first order (= half-life)
Key result
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Type:
(pseudo-)first order (= half-life)
Key result
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Type:
(pseudo-)first order (= half-life)
Details on results:
A Tier 1 hydrolysis of PFBSK+ was determined. No changes in the concentration were observed after 5 days at 50 °C and at pH 4, 7 , and 9. The % degradation at pH 4, pH 7 and pH 9 was less than 10% after 5 days at 50 °C. As defined in the tst guideline, since less than 10% of hydrolysis occurs after a period of 5 days at 50°C at pH levels of 4, 7 and 9, the test substance is considered hydrolytically stable (t1/2 at 25 °C > 1 year) and no further testing is required.

Any other information on results incl. tables

Table 1: Hydrolysis data for study A02/0124/05 LEV

pH

Initial Conc. (%)

Day 5 Conc. (%)

% Hydrolysis at 50 °C

4

98.3

98.2

< 10%

7

98.2

98.2

<10%

9

98.1

98.1

< 10%

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
PFBSK+ has a hydrolysis half life of > 1 year under environmental conditions (25°C), it is considered hydrolytically stable.
Executive summary:

A Tier 1 hydrolysis of PFBSK+ was determined according to EU method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH).

 

Samples were prepared at a concentration of approximately 0.1 mole/L of PFBSK+ in each of pH 4, 7, and 9 buffer system and 50 °C. The concentration was analyzed with F-NMR at day 0 and after 5 days. No changes in the concentration were observed and the Hydrolysis was determined by % loss of the parent material. The % hydrolysis at pH 4, pH 7 and pH 9 were less than 10%. As defined in EU method C.7 , since less than 10% of hydrolysis occurs after a period of 5 days at 50°C at pH levels of 4, 7 and 9, the test substance is considered hydrolytically stable (t1/2 @25°C > 1 year) and no further testing is required.

 

This is a guideline study conducted under GLP. However, it lacks detailed documentation on the analytical information. Therefore, it is considered reliable with restrictions.