Registration Dossier

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:
1994
Report Date:
1994

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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
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.