Registration Dossier

Administrative data

Endpoint:
sediment toxicity: long-term
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Column 2 Annex X REACH, the long-term toxicity testing does not need to be carried out as the results of the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on sediment organisms. According to results of hydrolysis study, the half time of degradation is estimated to be more than 1 year. Therefore, no degradation product of parental substance are expected in sediment. This resume is supported by triggering criteria in Guidance on information requirements and chemical safety assessment, Chapter R.7b, part R.7.8.10.3 c), point iii. Information on degradation of the parent compound in the water column showing formation of relevant metabolites (see Section R.7.1) that will be distributed to the sediment and point iv. Information on degradation of the parent compound in the sediment showing formation of metabolites exclusively in this compartment (i.e. indications of anaerobic/aerobic degradation in the sediment to relevant metabolites). Neither one of points is fulfiled for the substance.
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from January 23, 2007 to March 5. 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: 0, cca 1 day, cca 2 days, cca 4 days, cca 5 days
- Sampling method: sampling from volumetric flask by pipette and diluting with water to required concentration.
- Sampling intervals/times for pH measurements:
- Sampling intervals/times for sterility check:
- Sample storage conditions before analysis: The samples were analyzed in a short time after sampling.
- Other observation: no
- Temperature control: The actual temperature of the thermostatic bath was controlled during the whole test every when the sampling was done.
Buffers:
- pH: 4,7,9
- Type and final molarity of buffer: Buffer mixtures – Clark and Lubs
- Composition of buffer:
pH 4: phthalate buffer
pH 7: fosphate buffer
pH 9: borate buffer
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: volumetric flask 250 mL
- Sterilisation method: no
- Lighting: no (aluminium foil)
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no

TEST MEDIUM
- Volume used/treatment 250 mL
- Kind and purity of water: distilled water
- Preparation of test medium:
- Renewal of test solution:

OTHER TEST CONDITIONS
- Adjustment of pH: The actual pH value of each buffer was measured. The pH-meter calibrated to buffer solutions CertiPUR was used.
- Adjustment of temperature: The actual temperature of the thermostatic bath was controlled during the whole test every when the sampling was done. The calibrated thermometer was used and a temperature correction was taken into account via information from the calibration list.
Duration:
5 d
pH:
4.1
Temp.:
50 °C
Initial conc. measured:
ca. 1 g/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
ca. 1 g/L
Duration:
5 d
pH:
8.8
Temp.:
50 °C
Initial conc. measured:
ca. 1 g/L
Number of replicates:
2
Positive controls:
no
Negative controls:
no
Preliminary study:
The preliminary test shows that less than 10 % of the test substance was hydrolysed within 5 days period at the pH 4.1, 7.0 and 8.8. The half-life time of hydrolysis can therefore be expected grater than one year at 25°C and further testing was not required.
Transformation products:
no
Key result
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
hydrolytically stable based on preliminary test

Hydrolysis at pH 4

Results of preliminary test : pH = 4.1

Sampling

Measurement

Difference to time = 0

(%)

Time

(days)

Temperature

(°C)

No.

Absorbance

(AU)

0

50.0

I

A

1.3433

B

1.3441

II

A

1.3506

B

1.3490

Average

1.347

0.0

1.12

50.0

I

A

1.3085

B

1.3095

II

A

1.3129

B

1.3138

Average

1.311

-2.6

3.92

50.0

I

A

1.3507

B

1.3510

II

A

1.3385

B

1.3350

Average

1.344

-0.2

4.84

50.0

I

A

1.3320

B

1.3332

II

A

1.3301

B

1.3310

Average

1.332

-1.1

Hydrolysis at pH 7

Results of preliminary test : pH = 7.0

Sampling

Measurement

Difference to time = 0

(%)

Time

(days)

Temperature

(°C)

No.

Absorbance

(AU)

0

50.0

I

A

2.3225

B

2.3214

II

A

2.3238

B

2.3235

Average

2.323

0.0

1.06

50.0

I

A

2.3088

B

2.3203

II

A

2.3039

B

2.3011

Average

2.309

-0.6

3.90

50.0

I

A

2.2852

B

2.2885

II

A

2.2871

B

2.2877

Average

2.287

-1.5

4.82

50.0

I

A

2.3255

B

2.3244

II

A

2.3312

B

2.3309

Average

2.328

0.2

Hydrolysis at pH 9

Results of preliminary test : pH = 8.8

Sampling

Measurement

Difference to time = 0

(%)

Time

(days)

Temperature

(°C)

No.

Absorbance

(AU)

0

50.0

I

A

2.3383

B

2.3371

II

A

2.3361

B

2.3373

Average

2.337

0.0

1.07

50.0

I

A

2.3629

B

2.3603

II

A

2.3619

B

2.3614

Average

2.362

1.0

3.89

50.0

I

A

2.3310

B

2.3261

II

A

2.3291

B

2.3294

Average

2.329

-0.4

4.80

50.0

I

A

2.3413

B

2.3399

II

A

2.3361

B

-

Average

2.339

0.1

Validity criteria fulfilled:
yes
Conclusions:
The half-life times of hydrolysis at all tested pH (4, 7 and 9) and at 25°C were estimated as higher than 1 year.
Executive summary:

The half-life times of hydrolysis at all tested pH (4, 7 and 9) and at 25°C were estimated as higher than 1 year. The estimation is performed with respect to the results of preliminary test and with respect to the conclusion stated in the used methodology - Method C.7 – Degradation – Abiotic Degradation Hydrolysis as a Function of pH, Directive 92/69/EEC. Published in OJ No L 383A December 1992.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion