Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only results summary available

Principles of method if other than guideline:

A study was conducted to determine the extent and rate of hydrolysis of the test substance as a function of pH. The substance was placed in phosphate buffer at pH 7 and at 50°C. The measurements for % recovery were performed on Day 4 and eight samples were obtained.

GLP compliance:

not specified

Radiolabelling:

no

Analytical monitoring:

not specified

Buffers:

Phosphate buffer

Details on test conditions:

pH: 7
Temperature: 50°C

Number of replicates:

Two

Positive controls:

not specified

Negative controls:

not specified

Transformation products:

not specified

Key result

pH:

7

Temp.:

50 °C

Hydrolysis rate constant:

0 s-1

DT50:

59 d

Type:

not specified

Details on results:

The samples were obtained on 4 days, with two samples per day. The % recovery ranged from 93.5-100%.

Validity criteria fulfilled:

no

Conclusions:

Under the study conditions, the half-life and the hydrolysis rate constant of the test substance was determined to be 59 d and 1.35872E-07 per sec.

Executive summary:

A study was conducted to determine the extent and rate of hydrolysis of the test substance as a function of pH. The test substance was placed in phosphate buffer at pH 7 and at 50°C. The measurements for % recovery was performed on 4 d and eight samples were obtained. Under the study conditions, the half-life and the hydrolysis rate constant of the test substance were determined to be 59 d and 1.35872E-07 per sec (Maezulis, 1986).

Additional information

Waiver

An advanced hydrolysis study is scientifically not necessary. Dyes like Reactive Blue FC05717 maintain a very high level of fastness. In quality tests, the substance has shown resistance to hydrolysis in alkaline hot wash and in perspiration fastness tests (e.g. according to DIN 53160 at pH 2.5 – 8.6). Disregarding the split-off of the reactive group in the molecule (which only results in a change of the ratio main dye : auxiliary dyes that both bind to the target fibre), virtually no hydrolysis as function of pH happens to the dye molecule.

Supporting study

A study was conducted to determine the extent and rate of hydrolysis of the test substance as a function of pH. The test substance was placed in phosphate buffer at pH 7 and at 50°C. The measurements for % recovery was performed on 4 d and eight samples were obtained. Under the study conditions, the half-life and the hydrolysis rate constant of the test substance were determined to be 1416.8 h and 1.35872E-07 per sec (Maezulis, 1986).