Reaction product of {Sulfonic acid derivatives of [4-(aminoalkylamino)-6-substituted-1,3,5-triazin-2-ylamino]benzene}, ammonia water, sodium chloride and [poly(1~4)chlorosulfonyl(poly(1~4) benzo-poly(3~0)pyrido-5,10,15,20-tetraazaporphyrinato- N21,N22,N23,N24)]copper(II)

Hydrolysis

Administrative data

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Phys chem testing was conducted between 10 March 2011 and 12 April 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: TM10-099
Description: dark blue powder
Batch number: MB-1
Date received: 4 March 2011
Expiry date: 4 March 2012
Storage conditions: room temperature in the dark

Radiolabelling:

no

Study design

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent/transformation products: 0 and 120 hours
- Sampling intervals/times for pH measurements: various times

Buffers:

- pH: 4, 7, 9
- Composition of buffer:
pH 4: Potassium hydrogen phthalate, 0.05 mol/dm3
pH 7: Disodium hydrogen orthophosphate (anhydrous), 0.03 mol/dm3
Potassium dihydrogen orthophosphate, 0.02 mol/dm3
Sodium chloride, 0.02 mol/dm3
pH 9: Disodium tetraborate, 0.01 mol/dm3
Sodium chloride, 0.02 mol/dm3

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: stoppered glass flasks
- Sterilisation method: The buffer solutions were filtered through a 0.2 µm membrane filter to ensure they were sterile before commencement of the test.
- Lighting: The solutions were shielded from light whilst maintained at the test temperature.
- Measures taken to avoid photolytic effects: not reported
- Measures to exclude oxygen: The solutions were subjected to ultrasonication and degassing with nitrogen to minimise dissolved oxygen content
- If no traps were used, is the test system closed/open: closed
- Is there any indication of the test material adsorbing to the walls of the test apparatus? not reported

PREPARATION OF SAMPLES
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 1 g/L in the three buffer solutions. The test solutions were split into individual vessels for each data point. The solutions were shielded from light whilst maintained at the test temperature.

Duration of test

Duration of test 1

Duration:

120 h

pH:

4

Temp.:

50 °C

Initial conc. measured:

1.02 - 1.09 g/L

Duration of test 2

Duration:

120 h

pH:

7

Temp.:

50 °C

Initial conc. measured:

1.02 - 1.03 g/L

Duration of test 3

Duration:

120 h

pH:

9

Temp.:

50 °C

Initial conc. measured:

1.03 - 1.04 g/L

Number of replicates:

2 samples per pH

Positive controls:

no

Negative controls:

no

Results and discussion

Preliminary study:

Less than 10% hydrolysis was observed after 120 hours at 50°C, equivalent to a half-life greater than 1 year at 25°C for pH 4, pH 7 and pH 9.

Transformation products:

not specified

Dissipation DT50 of parent compound

Dissipation DT50 of parent compound 1

pH:

4

Temp.:

25 °C

DT50:

> 1 yr

Remarks on result:

other: Based on observation that less than 10% hydrolysis after 120 hours at 50°C

Dissipation DT50 of parent compound 2

pH:

7

Temp.:

25 °C

DT50:

> 1 yr

Remarks on result:

other: Based on observation that less than 10% hydrolysis after 120 hours at 50°C

Dissipation DT50 of parent compound 3

pH:

9

Temp.:

25 °C

DT50:

> 1 yr

Remarks on result:

other: Based on observation that less than 10% hydrolysis after 120 hours at 50°C

Details on results:

TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes

MAJOR TRANSFORMATION PRODUCTS
No data

Any other information on results incl. tables

A peak was observed in the matrix blank solutions at the approximate retention time of the test item. This was consistent and considered to be instrument carry-over. Since the standard and sample responses were corrected for this blank value, there was no

significant impact on the results.

As the test item was determined to be hydrolytically stable under acidic conditions (t1/2 > 1 year at 25°C) no additional testing was performed at pH 1.2, 37.0 ± 0.5 °C.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The half-life of the test material at 25°C was estimated to be greater than 1 year for pH 4, pH 7 and pH 9.

Executive summary:

The hydrolysis potential of the test item TM10-099 was determined in a valid GLP study. The determination was carried out using a procedure designed to be compatible with OECD TG No 111.

Duplicate sample solutions with a nominal concentration of 1 g/L with each pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 120 hours. Less than 10% hydrolysis was observed after 120 hours at 50 °C, which is equivalent to a half-life greater than 1 year at 25 °C for pH 4, pH 7 and pH 9.