Registration Dossier
Registration Dossier
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EC number: 417-790-1 | CAS number: 78418-01-6
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study with insufficient details to allow a full reliability assessment
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 417-790-1
- EC Name:
- -
- Cas Number:
- 78418-01-6
- Molecular formula:
- C15H20O4
- IUPAC Name:
- 2-Hydroxy-5-(1-oxooctyl)benzoic acid
- Reference substance name:
- MEXORYL SAB
- IUPAC Name:
- MEXORYL SAB
- Details on test material:
- - Name of test material (as cited in study report): MEXORYL SAB
- Physical state: solid
- Analytical purity: see confidential details on test material
- Impurities (identity and concentrations): see confidential details on test material
- Purity test date: see confidential details on test material
- Lot/batch No.: see confidential details on test material
- Expiration date of the lot/batch: see confidential details on test material
- Stability under test conditions: not reported
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Vapour pressure: no data
- Water solubility: insoluble at 0.1% in water
- pKa: no data - Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: 0-144-1320-2760-7200 min
- No experimental details are provided - Buffers:
- - pH: 4-7-9
- No details on composition of buffer - Details on test conditions:
- No details on test conditions
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 5.477 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 6.113 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 6.163
- Number of replicates:
- No data
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- no data
Results and discussion
- Preliminary study:
- No
- Test performance:
- No data
- Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- No detail.
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- > 120 h
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- > 120 h
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- > 120 h
- Other kinetic parameters:
- None
- Details on results:
- No data
Any other information on results incl. tables
Table 5.1.2/1: Experimental data for pH = 4
Time (min) |
0 |
144 |
1320 |
2760 |
7200 |
Replicate 1 |
5.477 |
5.701 |
5.884 |
5.793 |
5.755 |
Replicate 2 |
5.696 |
5.564 |
5.473 |
5.743 |
5.494 |
Mean |
5.587 |
5.633 |
5.679 |
5.768 |
5.625 |
Ct/Co |
0.00 |
0.01 |
0.02 |
0.03 |
0.01 |
Table 5.1.2/2: Experimental data for pH = 7
Time (min) |
0 |
144 |
1320 |
2760 |
7200 |
Replicate 1 |
6.113 |
6.310 |
6.004 |
6.152 |
6.227 |
Replicate 2 |
6.163 |
6.382 |
6.262 |
6.174 |
6.401 |
Mean |
6.138 |
6.346 |
6.133 |
6.163 |
6.314 |
Ln (Ca/Ca0) |
0.00 |
0.03 |
0.00 |
0.00 |
0.03 |
Table 5.1.2/3: Experimental data for pH = 9
Time (min) |
0 |
144 |
1320 |
2760 |
7200 |
Replicate 1 |
6.163 |
6.256 |
6.321 |
6.263 |
6.357 |
Replicate 2 |
6.090 |
6.203 |
6.063 |
6.270 |
6.144 |
Mean |
6.127 |
6.230 |
6.192 |
6.267 |
6.251 |
Ln (Ca/Ca0) |
0.00 |
0.02 |
0.01 |
0.02 |
0.02 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Under the conditions of this test, MEXORYL SAB was found stable to hydrolysis.
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