Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study according OECD 111 and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Qualifier:
according to
Guideline:
EPA OPPTS 835.2110 (Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium vinyl sulphonate solution (Provichem 2202)
- Analytical purity: 25.09%
- Lot/batch No.: 200911040014
- Storage condition of test material: Ambient room temperature 20-30°C

Study design

Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: hydrolysis samples were collected from each pH after the test solution was placed into the test vessels (0h) and at 2h, 5h, 1d, 5d.
- Sampling method:At each sampling interval for each buffer test system, duplicate samples were taken and analyzed by HPLC.
- Sampling intervals/times for pH measurements:The pH of the buffer solutions were measured after preparation and sterile filtration. The pH was also documented after sample fortification of pH 4, 7 and 9 buffer test solution on Day 0 and Day 5.
- Sampling intervals/times for sterility check: Sterility was determined at Day 0 for sterile pH 4, 7 and 9 buffer test systems and at day 5 for pH 4, 7 and 9 buffer test system. Sterility was checked by serial dilution plate technique. Agar plates (Nutrient agar for bacteria) were used to determine sterility of buffer test systems.
-Samples were analyzed on the sampling day
Buffers:
- pH: 4, 7, 9
- Type and final molarity of buffer,Composition of buffer:
pH4: 0.01 M: 410 mL of 0.01 M acetic acid solution with 90 mL of 0.01 M sodium acetate solution
pH7: 0.02M: 195 mL of 0.02M sodium phosphate (monobasic) and 305 mL of 0.02M sodium phosphate (dibasic) to a 1000mL flask
pH9: 0.5M boric acid:
Details on test conditions:

TEST MEDIUM
- Volume used/treatment: nominal test item concentration was 50 mg/L
- Kind and purity of water: Milli-Q-water
- Preparation of test medium: dilution of stock solution with filter-sterilized buffer solution to obtain 50 mg/L
Duration of testopen allclose all
Duration:
0 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
49.9 mg/L
Duration:
0 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
50.3 mg/L
Duration:
0 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
50.6 mg/L
Number of replicates:
2 replicates per test system
Positive controls:
not specified
Negative controls:
not specified
Statistical methods:
The base 10 logarithm of the concentration of SVS was plotted as a function of time and the line fit to the data was determined using Excel.

Results and discussion

Preliminary study:
Analysis of pH4 buffer at Day 5 showed >90% of the recovered test item compared to the 0h analysis. Analysis of pH7 buffer at Day 5 showed >90% of the recovered test item compared to the 0h analysis. Analysis of pH9 buffer at Day 5 showed >90% of the recovered test item compared to the 0h analysis. SVS was hydrolytically stable at pH 4, 7, and 9 based on preliminary result. So definitive study was not conducted.
Total recovery of test substance (in %)open allclose all
% Recovery:
> 90
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
> 90
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
> 90
pH:
9
Temp.:
50 °C
Duration:
5 d

Applicant's summary and conclusion

Conclusions:
This study demonstrated that Sodium vinyl sulphonate solution (provichem 2202) was hydrolitically stable at pH 4, 7 and 9. Based on the results of this study, hydrolysis will not be a route of degradation of SVS in the environment.