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Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
Batch number: 022401
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
Portions of the solutions were taken from the flasks, diluted with water to obtain concentrations within the calibration range and the
concentration of the test substance was analysed by HPLC.
Buffers:
Buffer pH 4: 250 mL 0.1 mol/L potassium dihydrogencitrate (Fluka; Lot. No. 364546/1) and 45 mL 0.1 mol/L sodium hydroxide (Titrisol; Merck, Lot. No. OC489094) filled up to 500 mL with water.
Buffer pH 7: 250 mL 0.1 mol/L potassium dihydrogenphosphate (Merck, Lot. No. A531473427) and 148.2 mL 0.1 mol/L sodium hydroxide filled up to 500 mL with water.
Buffer pH 9: 250 mL 0.1 mol/l boric acid (Merck, Lot. No. A577065513) in 0.1 mol/L potassium chloride (Merck, Lot. No. K31517236313) and 106.5 mL 0.1 mol/L sodium hydroxide filled up to 500 mL with water.
Details on test conditions:
The water for analysis was autoclaved before use.
- Type, material and volume of test flasks, other equipment used:
- Sterilisation method:
- Lighting:
- Measures taken to avoid photolytic effects:
- Measures to exclude oxygen:
- Details on test procedure for unstable compounds:
- Details of traps for volatile, if any
- If no traps were used, is the test system closed/open
- Is there any indication of the test material adsorbing to the walls of the test apparatus?
TEST MEDIUM
- Volume used/treatment
- Kind and purity of water:
- Preparation of test medium:
- Renewal of test solution:
- Identity and concentration of co-solvent:
OTHER TEST CONDITIONS
- Adjustment of pH:
- Dissolved oxygen:
Duration of testopen allclose all
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 0.01 mol/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 0.01 mol/L
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 0.01 mol/L

Results and discussion

Preliminary study:
In the preliminary test, solutions of < 50 % saturation and < 0.01 mol/L of the test substance in buffers with pH values of 4, 7 and 9 were kept at 50 °C and the concentration of "STI571 F8" was determined after various times up to a maximum of 5 days.
The preliminary test indicated that the half-lifes of the base of the test substance at 25 °C at pH 4, pH 7 and pH 9 will be greater than 1 year. Therefore the test substance is considered to be stable to hydrolysis and no main test was performed, according to the guideline.
Transformation products:
not measured
Remarks:
The test substance is the hydrochloride of a base and by this the test substance dissociates in water to chloride and the protonated base. The essential part of the test substance is the base.
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
50 °C
Hydrolysis rate constant:
ca. 0 s-1
DT50:
2 500 h
pH:
4
Temp.:
25 °C
DT50:
> 8 760 h
pH:
7
Temp.:
50 °C
Hydrolysis rate constant:
ca. 0 s-1
DT50:
3 060 h
pH:
7
Temp.:
25 °C
DT50:
> 8 760 h
pH:
9
Temp.:
50 °C
Hydrolysis rate constant:
ca. 0 s-1
DT50:
3 030 h
pH:
9
Temp.:
25 °C
DT50:
> 8 760 h

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Conclusions:
The preliminary test indicated that the half-lifes of the base of the test substance at 25 °C at pH 4, pH 7 and pH 9 will be greater than 1 year. Therefore the test substance is considered to be stable to hydrolysis .