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Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2016
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
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
ammonium (1Z)-N-(2-methyl-1-sulfopropan-2-yl)prop-2-enimidate
EC Number:
611-646-3
Cas Number:
58374-69-9
Molecular formula:
C7H12NO4S.H4N
IUPAC Name:
ammonium (1Z)-N-(2-methyl-1-sulfopropan-2-yl)prop-2-enimidate
Test material form:
liquid
Specific details on test material used for the study:
Identification 2-ACRYLAMIDO-2-METHYLPROPANESULFONIC
ACID, AMMONIUM SALT
Batch DP/MFR2174
Manufacturing date Not provided
Expiry date 11 July 2017
Supplier SNF SAS
Appearance Slightly yellow liquid
Packaging Transparent PE flask
Quantity received 1 L
Date of receipt 25 July 2016
Storage In darkness at room temperature
Identification number 16-034
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
Number of samples analysed = 12 (six at T = 0 and six at 5 days).
Buffers:
Boric acid ≥ 99.8%
Citric acid ≥ 99%
Dibasic sodium phosphate ≥ 99%
1-octanol
Potassium dihydrogen phosphate ≥ 99%
Potassium hydrogeno-phthalate ≥ 99.5%
Potassium chloride ≥ 99%
Sodium hydroxide ≥ 98%
Duration of testopen allclose all
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 0.28 - <= 0.29 mg/L
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 1.03 - <= 1.04 mg/L
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 2.82 - <= 2.83 mg/L
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 5.15 - <= 5.2 mg/L
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 10.68 - <= 10.73 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 0.28 - < 0.29 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 1.03 - <= 1.04 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 2.82 - <= 2.83 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 5.15 - <= 5.2 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 10.68 - <= 10.73 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 0.28 - <= 0.29 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 1.03 - <= 1.04 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 2.82 - <= 2.83 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 5.15 - <= 5.2 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 10.68 - <= 10.73 mg/L
Number of replicates:
12
Positive controls:
no
Negative controls:
no

Results and discussion

Preliminary study:
At pH 4, less than 10% of degradation was observed after 5 days. The test item was considered hydrolytically stable and no additional assay was done.
At pH 7, less than 10% of degradation was observed after 5 days. The test item was considered hydrolytically stable and no additional assay was done.
At pH 9, less than 10% of degradation was observed after 5 days. The test item was considered hydrolytically stable and no additional assay was done.
Transformation products:
not specified
Total recovery of test substance (in %)open allclose all
% Recovery:
> 90
pH:
4
Temp.:
50 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
> 90
pH:
7
Temp.:
50 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
> 90
pH:
9
Temp.:
50 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
Dissipation DT50 of parent compoundopen allclose all
Key result
pH:
4
Temp.:
50 °C
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
7
Temp.:
50 °C
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
9
Temp.:
50 °C
Remarks on result:
hydrolytically stable based on preliminary test

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
At pH 4, 7 and 9, less than 10% of degradation was observed after 5 days. The test item was considered hydrolytically stable and no additional assay was done.