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Environmental fate & pathways

Hydrolysis

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Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
[Reaction mass of 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4-[2-[4-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo]-2-sulfophenyl]ethenyl]-3-sulfophenyl]azo]-4-hydroxy-, compd. with 2,2',2''-nitrilotris[ethanol] (1:5) and 3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:6) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:4)]
EC Number:
916-899-6
Molecular formula:
not available
IUPAC Name:
[Reaction mass of 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4-[2-[4-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo]-2-sulfophenyl]ethenyl]-3-sulfophenyl]azo]-4-hydroxy-, compd. with 2,2',2''-nitrilotris[ethanol] (1:5) and 3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:6) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:4)]
Test material form:
liquid
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Buffers:
Citrate Buffer (0.05 M): pH 4
Phosphate Buffer (0.05 M): pH 7
Borate Buffer (0.05 M): pH 9
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: glass volumetric flasks
- Sterilisation method: filtration through pre-assembled sterile 500 mL filters (Nalgene).
- Lighting: performed under dark conditions
- Measures taken to avoid photolytic effects: dark conditions
- Measures to exclude oxygen: each sterilized buffer solution was purged in a gentle stream of nitrogen for approx. 20 min to deplete any dissolved oxygen.
- open system
- No indication of the test material adsorbing to the walls of the test apparatus

TEST MEDIUM
- Volume used/treatment 10 mL
- Kind and purity of water: Millipore
- Mobile phase: Solvent A: 0.05 M Ammonium acetate in Millipore water, Solvent B:Acetonitrile

OTHER TEST CONDITIONS
- Adjustment of pH: buffers used
Number of replicates:
3 replicates at each pH level
Positive controls:
no
Negative controls:
yes
Remarks:
Blanks were tested

Results and discussion

Preliminary study:
The average recoveries obtained in Tier 1 testing were always in the range of 90-110 %. All main components of the substance were hydrolyzed less than the 10 %. This indicated a sufficient hydrolytic stability of three components of the test item different buffer solutions after 5 days of incubation at 50 °C.
Transformation products:
not measured
Total recovery of test substance (in %)open allclose all
% Recovery:
> 93.4 - < 103
St. dev.:
9.3
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
> 93.9 - < 99.9
St. dev.:
10.1
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
> 95.9 - < 97.1
St. dev.:
8.9
pH:
9
Temp.:
50 °C
Duration:
5 d
Dissipation DT50 of parent compound
Key result
Remarks on result:
hydrolytically stable based on preliminary test

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The substance is hydrolytically stable.
Executive summary:

No significant hydrolysis (≤ 10 %) was observed in the preliminary test at 50 °C for all tested pH values (4, 7, 9) of the test item. This indicates a half-life period of analytes at 25 °C of more than 1 year (t0.5 25°C > 1 year). Thus, the test item was considered to be hydrolytically stable and a further testing (Tier 2 experiments) (according to OECD guideline 111) is not required.