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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study experimental phase 2012-11-13 to 2013-01-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as reliable without restriction according to Klimisch et al (1997).

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine
EC Number:
696-145-8
Cas Number:
944730-39-6
Molecular formula:
C44H36CuN8O20S8 .4Na
IUPAC Name:
tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
Analysis of the tests by HPLC was carried out initially and at 5 days.

For the initial HPLC analysis, the above remaining test solutions were left to reach room temperature and then 0.25 ml of each hydrolysis test was diluted to 100.0 ml with ELGA Ultrapure water.

For the 5 days hydrolysis analysis, one vial of each test was removed from the oven after 5 days and allowed to cool to room temperature. 0.25 ml of each test was diluted to 100.0 ml with ELGA Ultrapure water.
Buffers:
Buffer blanks were also run to demonstrate specificity.

Preparation of Buffer Solutions
pH 4.0 Buffer Solution
164ml of 0.2M acetic acid solution was added to 36ml of 0.2M sodium acetate and diluted to 1 litre with ELGA Ultrapure water. The solution was degassed with helium.

pH 7.0 Buffer Solution
296ml of 0.1N sodium hydroxide solution was added to 500ml of 0.1M monopotassium phosphate solution and diluted to 1 litre with ELGA Ultrapure water. The solution was degassed with helium.

pH 9.0 Buffer Solution
213ml of 0.1N sodium hydroxide solution was added to 500ml of 0.1M boric acid in 0.1M potassium chloride and diluted to 1 litre with ELGA Ultrapure water. The solution was degassed with helium.
Details on test conditions:
TEST SYSTEM
- Sterilisation method: All glassware used during the analysis was autoclaved before use. All buffers were autocalved at 121ºC for 15 min and then placed in a 50ºC oven to warm overnight.
- Measures to exclude oxygen: Buffer solutions were degassed with helium.

OTHER TEST CONDITIONS
- Adjustment of pH: The pH of each buffer solution was measured prior to use and no pH adjustment was required. The initial pH's of all test solutions were within 0.1 pH units of required pH, therefore no pH adjustment was necessary.
- Dissolved oxygen:
Duration of testopen allclose all
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
12 094 mg/L
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
13 260 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
13 251 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
12 864 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
12 763 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
13 412 mg/L
Number of replicates:
2 per pH

Results and discussion

Preliminary study:
The results of the initial HPLC analysis show that at pH 4.0, 7.0 and 9.0 there had been less than 10% hydrolysis after 5 days at 50ºC ±0.5ºC versus the initial time point. Therefore no further work is required.
Transformation products:
not measured
Total recovery of test substance (in %)open allclose all
% Recovery:
99.9
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
100.2
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
100.2
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
99.9
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
100
pH:
9
Temp.:
50 °C
Duration:
5 d
% Recovery:
100.2
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 results of the initial HPLC analysis show that at pH 4.0, 7.0 and 9.0 there had been less than 10% hydrolysis after 5 days at 50ºC ±0.5ºC versus the initial time point. Therefore no further work is required.
Executive summary:

Introduction

This study was undertaken to to assess hydrolysis of the test material as a function of pH. The method was designed to be compatible with OECD Guideline 111.

Results & Conclusions

The results of the initial HPLC analysis show that at pH 4.0, 7.0 and 9.0 there had been less than 10% hydrolysis after 5 days at 50ºC ±0.5ºC versus the initial time point. Therefore no further work was carried out.