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Diss Factsheets

Environmental fate & pathways

Biodegradation in water: screening tests

Administrative data

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 01, 1999-October 21, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
434-770-8
EC Name:
-
Cas Number:
55314-16-4
Molecular formula:
C10 H12 N2 O1
IUPAC Name:
3-(dimethylamino)-1-(pyridin-3-yl)prop-2-en-1-one
Details on test material:
Name of test material (as cited in study report): STI571 Y5a
- Substance type: Brown solid
- Physical state: Solid
- Analytical purity: 98.6%
- Lot/batch No.: 992301
- Expiration date of the lot/batch: 01 July 2001
- Stability under storage conditions: Stable
- Storage condition of test material: In refrigerator in the dark
- Solubility in water: Not indicated

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Details on inoculum:
Source:
The source of test organisms was activated sludge freshly obtained from a municipal sewage treatment plant: 'Waterschap de Maaskant', 's-Hertogenbosch, the Netherlands.

Treatment:
The sludge was kept under continuous aeration until further treatment. The concentration of suspended solids was 3.8 g/l in the concentrated sludge (information obtained from the municipal sewage treatment plant). Before use, the sludge was allowed to settle for at least 30 minutes and the liquid decanted for use as inoculum at the amount of 10 ml/l of mineral medium
Duration of test (contact time):
28 d
Initial test substance concentrationopen allclose all
Initial conc.:
17.5 mg/L
Based on:
test mat.
Initial conc.:
12 mg/L
Based on:
other: Total Organic Carbon (TOC)
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
TEST CONDITIONS
- Composition of medium: 1 litre mineral medium contains: 10 ml of solution (A), 1 ml of solutions (B) to (D) and Milli-RO water
Stock solutions of mineral components
A) 8.50 g KH2PO4; 21.75 g K2HPO4; 67.20 g Na2HPO4.12H2O; 0.50 g NH4Cl; dissolved in Milli-Q water and made up to 1 litre, pH 7.4 ± 0.2
B) 22.50 g MgSO4.7H2O dissolved in Milli-Q water and made up to 1 litre.
C) 36.40 g CaCl2.2H2O dissolved in Milli-Q water and made up to 1 litre.
D) 0.25 g FeCl3.6H2O dissolved in Milli-Q water and made up to 1 litre.

- Test temperature: The temperature recorded in a vessel with water in the same room varied between 20 and 23°C, except on nominal day 27. On nominal day 27 a deviation of 1°C from the temperature range mentioned in the protocol was noted (19°C), but this was considered to have no effect on the integrity of this study.

- pH:
At t=0 d: 7.6
At t=28 d: 7.5 – 7.8
- pH adjusted:no
- Aeration of dilution water: Not before the test, the test is aerated continously
- Suspended solids concentration: The sludge was kept under continuous aeration until further treatment. The concentration of suspended solids was 3.8 g/l in the concentrated sludge (information obtained from the municipal sewage treatment plant). Before use, the sludge was allowed to settle for at least 30 minutes and the liquid decanted for use as inoculum at the amount of 10 ml/l of mineral medium.
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus: 2 litre all-glass brown coloured bottles
- Number of culture flasks/concentration:
Test suspension: containing test substance and inoculum (2 bottles).
Inoculum blank: containing only inoculum (2 bottles)
Positive control: containing reference substance and inoculum (1 bottle).
Toxicity control: containing test substance, reference substance and inoculum (1 bottle).
- Method used to create aerobic conditions:
A mixture of oxygen (21%) and nitrogen (79%) was sparged through the scrubbing solutions at a rate of approximately 1-2 bubbles per second (ca. 30-100 ml/min).
- Test performed in open system: yes
- Details of trap for CO2 and volatile organics if used:
The CO2 produced in each test bottle reacted with the barium hydroxide in the gas scrubbing bottle and precipitated out as barium carbonate. The amount of CO2 produced was determined by titrating the remaining Ba(OH)2 with 0.05 M standardized HCl. Titrations were made every second or third day during the first 10 days, and thereafter at least every fifth day until the 28th day.

SAMPLING
- Sampling frequency: Titration were made on day: 2, 5, 7, 13, 14, 19, 23, 27 and 29
- Sampling method: Titration of the whole volume of CO2-absorber

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Abiotic sterile control: no
- Toxicity control: yes


Reference substance
Reference substance:
acetic acid, sodium salt

Results and discussion

% Degradationopen allclose all
Parameter:
% degradation (CO2 evolution)
Value:
50
Sampling time:
29 d
Remarks on result:
other: HCl added on the 28th day (last CO2-measurement on the 29th day)
Parameter:
% degradation (CO2 evolution)
Value:
58
Sampling time:
29 d
Remarks on result:
other: HCl added on the 28th day (last CO2-measurement on the 28 th day)
Details on results:
In the toxicity control more than 25% degradation occurred within 14 days (based on ThCO2). Therefore, the test substance was assumed to be not inhibitory.

BOD5 / COD results

Results with reference substance:
The positive control substance was degraded at least 60% within 7 days

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
other: STI571 Y5A was degraded significantly (50 and 58%)However, since at least 60% biodegradation was not reached within 28 days, within ten days of biodegradation exceeding 10%, the criterion for ready biodegradability was not met.
Conclusions:
Under the conditions of this test STI571 Y5A was not readily biodegradable.