Registration Dossier

Administrative data

Endpoint:
sediment toxicity: long-term
Data waiving:
study scientifically not necessary / other information available
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.
Test performance:
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
Details on results:
TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: yes
- Anomalies or problems encountered (if yes): no

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

1.2706

B

1.2702

II

A

1.2631

B

1.2623

Average

1.267

0

1.12

50.0

I

A

1.2316

B

1.2314

II

A

1.2335

B

1.2332

Average

1.232

-2.7

3.92

50.0

I

A

1.2442

B

1.2447

II

A

1.2394

B

1.2373

Average

1.241

-2.0

4.84

50.0

I

A

1.2525

B

1.2516

II

A

1.2583

B

1.2573

Average

1.255

-0.9

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

2.3560

B

2.3574

II

A

2.3695

B

2.3703

Average

2.363

0

1.06

50.0

I

A

2.3661

B

2.3662

II

A

2.3565

B

2.3581

Average

2.362

-0.1

3.90

50.0

I

A

2.3474

B

2.3454

II

A

2.3431

B

2.3411

Average

2.344

-0.8

4.82

50.0

I

A

2.3669

B

2.3731

II

A

2.3828

B

2.3878

Average

2.378

0.6

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

2.5071

B

2.5084

II

A

2.5101

B

2.5096

Average

2.509

0

1.07

50.0

I

A

2.5032

B

2.5052

II

A

2.5108

B

2.5074

Average

2.507

-0.1

3.89

50.0

I

A

2.5216

B

2.5205

II

A

2.5499

B

2.5505

Average

2.536

1.1

4.80

50.0

I

A

2.5102

B

2.5134

II

A

2.5073

B

2.5047

Average

2.509

0.0

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 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