Cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, sodium salts

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 May 1993 and 1 October 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)

Version / remarks:

Method C7 of Commission Directive 92/ 69/ EEC (which constitutes Annex V of Council Directive 67/ 548/EEC).

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

No further details specified in the study report.

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

The concentration of test material was monitored by high performance liquid chromatography (H.P.L.C.)

Buffers:

SPECIFICATION OF BUFFER SOLUTIONS
pH 4
Citric acid: 0.05 M
Sodium hydroxide: 0.10 M
Hydrochloric acid0.05 M

pH 7
Disodium hydrogen orthophosphate: 0.04127 M
Potassium dihydrogen orthophosphate: 0.0282 M

pH 9
Disodium tetraborate: 0.05 M
Hydrochloric acid: 0.0192 M

Solutions of the test material were prepared at approximately 10 g/1 in the above buffer solutions and maintained at 50 °C for 5 days.

Details on test conditions:

Samples
The sample solutions were diluted by a factor of 10 using methanol.

Standards
Standard solutions were prepared in methanol:water (9:1) at a nominal concentration of 1000 mg/L.

Duration:

5 d

pH:

4

Temp.:

50 °C

Initial conc. measured:

10.1 g/L

Duration:

5 d

pH:

7

Temp.:

50 °C

Initial conc. measured:

10.1 g/L

Duration:

5 d

pH:

9

Temp.:

50 °C

Initial conc. measured:

10.1 g/L

Number of replicates:

Not specified

Positive controls:

not specified

Negative controls:

not specified

Preliminary study:

Not specified

Test performance:

Not specified

Transformation products:

not specified

Details on hydrolysis and appearance of transformation product(s):

Not specified

% Recovery:

100

pH:

4

Temp.:

50 °C

Duration:

5 d

% Recovery:

95.3

pH:

7

Temp.:

50 °C

Duration:

5 d

% Recovery:

96.4

pH:

9

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

Other kinetic parameters:

Not specified

Details on results:

JPR BLUE 100 (lot Number 303001) was found to undergo less than 10% hydrolysis after 5 days at 50 °C in pH 4, and 7 and 9 buffer solutions.

The peak areas of the pair of standards associated with each sample were corrected to nominal concentration and the mean value taken prior to the calculation of the sample concentration.

Results with reference substance:

Not specified

The peak areas relating to the standard and sample solutions are detailed below:

Solution	Solution pH	Peak area (units)
Standard 1.08 x 10^3mg/l Standard 1.05 x 10^3mg/l Initial Sample Initial Sample Initial Sample	4 7 9	1.099 x 10^6 1.057 x 10^6 9.618 x 10^5 9.322 x 10^5 1.016 x 10^6
Standard 1.08 x 10^3mg/l Standard 1.05 x 10^3mg/l 2.4 Hour Sample 2.4 Hour Sample 2.4 Hour Sample	4 7 9	1.110 x 10^6 1.069 x 10^6 8.790 x 10^5 9.146 x 10^5 1.016 x 10^6
Standard 1.07 x 10^3mg/l Standard 1.02 x 10^3mg/l 48 Hour Sample 48 Hour Sample 48 Hour Sample	4 7 9	1.109 x 10^6 1.033 x 10^6 1.012 x 10^6 9.800 x 10^5 1.038 x 10^6
Standard 1.04 x 10^3mg/l Standard 1.01 x 10^3mg/l 120 Hour Sample 120 Hour Sample 120 Hour Sample	4 7 9	1.079 x 10^6 1.052 x 10^6 9.866 x 10^5 9.112 x 10^5 1.004 x 106

 

	pH 4	pH 7	pH 9
Concentration as weighed (g/l) Concentration found initially (g/l)	10.1 9.48	10.1 9.18	10.1 10.0
Concentration found at 2.4 hours (g/l) Expressed as % of the initial concentration	8.57 90.4	8.91 97.1	9.90 98.9
Concentration found at 48 hours (g/l) Expressed as % of the initial concentration	9.90 104	9.59 104	10.2 101
Concentration found at 120 hours (g/l) Expressed as % of the initial concentration	9.48 100	8.75 95.3	9.65 96.4

 

Validity criteria fulfilled:

not specified

Conclusions:

JPR BLUE 100 (lot Number 303001) was found to undergo less than 10% hydrolysis after 5 days at 50 °C in pH 4, and 7 and 9 buffer solutions.

Executive summary:

A number of general physico-chemical properties of the compound JPR BLUE 100 (Lot Number 303001) have been determined at the request of the sponsor.

 

The Hydroylsis study complied with Method C7 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

 

JPR BLUE 100 (lot Number 303001) was found to undergo less than 10% hydrolysis after 5 days at 50 °C in pH 4, and 7 and 9 buffer solutions.

Description of key information

JPR BLUE 100 (lot Number 303001) was found to undergo less than 10% hydrolysis after 5 days at 50 °C in pH 4, and 7 and 9 buffer solutions.

Additional information

A number of general physico-chemical properties of the compound JPR BLUE 100 (Lot Number 303001) have been determined at the request of the sponsor.

The Hydroylsis study complied with Method C7 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

JPR BLUE 100 (lot Number 303001) was found to undergo less than 10% hydrolysis after 5 days at 50 °C in pH 4, and 7 and 9 buffer solutions.