Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001-08-07 to 2002-03-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): T002113
- Physical state: solid, powder
- Analytical purity: 92.9%
- Lot/batch No.: RT002113G3A231
- Expiration date of the lot/batch: 2001-12-01
- Storage condition of test material: at room temperature at about 20°C
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
RT00211G3A231
- Expiration date of the lot/batch:
2001-12-01 (retest date)
- Purity test date:
no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature at about 20°C
- Stability under test conditions:
no data
- Solubility and stability of the test substance in the solvent/vehicle:
no data

Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: Aliquots of each test solution (10 µL) were analysed at the beginning, after 2.4 h, after 120 h and after 381 hours.
- Sampling intervals/times for pH measurements: not reported
- Sampling intervals/times for sterility check: not reported
- Sample storage conditions before analysis: not reported
Buffers:
- pH: 4, 7, 9
- Type of buffer:
* pH 4: component: Biphtalate
* pH 7: component: phosphate
* pH 9: component: borate
- Buffer solutions were sterilized for 25 min in an autoclave prior to first use.
- Nitrogen was passed through the buffer solutions for 2 minutes except when freshly sterilized.
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 50-mL glass Erlenmeyer flasks stoppered or sealed with inert material (e.g PTFE), fillvolume 50 mL. The test was repeated with silanisated glass vessel.
- Sterilisation method: glassware rinsed with sterile buffer, buffer solutions autoclaved for 25 minutes
- Lighting: not reported
- Measures to exclude oxygen: nitrogen passed through buffer solutions for 2 min to reduce the oxygen in the solution.

TEST MEDIUM
- Volume used/treatment: 50 mL
- Kind and purity of water: water from Milli-Q supply
- Preparation of test medium: an amount of T002113 was dissolved in 100 mL buffer solution (pH 4, 7 or 9). The solution was ultrasonified and filtrated (0.2 µm). 2 aliquots of this solution of ~50 mL each were transferred into 50 mL flasks in order to perform a duplicate test.
Duration of testopen allclose all
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 101.5 - <= 105.5 other: µg/mL
Duration:
381 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
>= 111.6 - <= 115.2 other: µg/mL
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 81.8 - <= 84 other: µg/mL
Duration:
381 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
>= 64.8 - <= 67.2 other: µg/mL
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 97.7 - <= 98.5 other: µg/mL
Duration:
381 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
>= 79.4 - <= 84.5 other: µg/mL
Number of replicates:
2
Positive controls:
no
Negative controls:
no
Statistical methods:
not specified

Results and discussion

Preliminary study:
A preliminary study was performed at 50°C ± 1 °C at each of pH 4, 7 and 9 in duplicate. Therefore a second test was performed with silanised glass vessels and elongated sampling period up to 16 days. Results are as follows:

pH 4
Normal glass
- 0 hours: initial concentration measured: 101.5-105.5 µg/mL
- 2.4 hours: concentration measured: 100.5-101.4 µg/mL
- 5 days: concentration measured: 36.1 - 36.6 µg/mL

silanised glass
- 0 hours: initial concentration measured: 111.6 - 115.2 µg/mL
- 2.4 hours: concentration measured: 108.2 - 108.4 µg/mL
- 5 days: concentration measured: 46.2 - 46.9 µg/mL
- 16 days: concentration measured: 31.0 - 32.6 µg/mL

pH 7
Normal glass
- 0 hours: initial concentration measured: 81.8 - 84.0 µg/mL
- 2.4 hours: concentration measured: 42.6 - 46 µg/mL
- 5 days: concentration measured: 42.9 - 43.8 µg/mL

Silanised glass
- 0 hours: initial concentration measured: 64.8 - 67.2 µg/mL
- 2.4 hours: concentration measured: 45.2 - 45.6 µg/mL
- 5 days: concentration measured: 37.6 - 44.0 µg/mL
- 16 days: concentration measured: 30.2 - 34.9 µg/mL

pH 9
- 0 hours: initial concentration measured: 97.7 - 98.5 µg/mL
- 2.4 hours: concentration measured: 71.4 - 74.2 µg/mL
- 5 days: concentration measured: 61.6 - 67.2 µg/mL

Silanised glass
- 0 hours: initial concentration measured: 79.4 - 84.5 µg/mL
- 2.4 hours: concentration measured: 73.6 - 78.4 µg/mL
- 5 days: concentration measured: 50.8 - 61.6 µg/mL
- 16 days: concentration measured: 29.5 - 39.5 µg/mL
Test performance:
T002113 does not degrade completely up to 16 days.
Transformation products:
not specified
Details on hydrolysis and appearance of transformation product(s):
no data
Total recovery of test substance (in %)open allclose all
% Recovery:
ca. 35 - ca. 36
pH:
4
Temp.:
50 °C
Duration:
120 h
Remarks on result:
other: normal glass vessels
% Recovery:
ca. 27 - ca. 29
pH:
4
Temp.:
50 °C
Duration:
381 h
Remarks on result:
other: silanised glass vessels
% Recovery:
ca. 52
pH:
7
Temp.:
50 °C
Duration:
120 h
Remarks on result:
other: normal glass vessels
% Recovery:
ca. 45 - ca. 54
pH:
7
Temp.:
50 °C
Duration:
381 h
Remarks on result:
other: silanised glass vessels
% Recovery:
ca. 63 - ca. 69
pH:
9
Temp.:
50 °C
Duration:
120 h
Remarks on result:
other: normal glass vessels
% Recovery:
ca. 35 - ca. 60
pH:
9
Temp.:
50 °C
Duration:
381 h
Remarks on result:
other: silanised glass vessels
Dissipation half-life of parent compoundopen allclose all
pH:
9
Temp.:
25 °C
Half-life:
> 1 yr
pH:
4
Temp.:
25 °C
Half-life:
> 1 yr
Key result
pH:
7
Temp.:
25 °C
Half-life:
> 1 yr

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Conclusions:
Hydrolysis was studied for T002113 following guideline OECD 111 during 5 days at pH 4, 7 and 9 and at 50°C. the measured concentrations indicates a fast degradation during the first hours at pH 7.0 and pH 9.0. Afterwards the degradation is much lower. A second test was performed with silanised glass vessels and elongated sampling period up to 16 days. T002113 does not degrade completely up to 16 days indicating a very slow degradation. It was concluded that the estimated half-life time at 25°C is longer than 1 year at pH 4.0, 7.0 and 9.0. Therefore, no further testing was performed. The results of the test can be considered reliable without restriction.