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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:
Experimental starting: 23 October, 2008 - Experimental completion: 21 November, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to international guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(m-benzoylphenyl)propionitrile
EC Number:
255-982-5
EC Name:
2-(m-benzoylphenyl)propionitrile
Cas Number:
42872-30-0
Molecular formula:
C16H13NO
IUPAC Name:
2-(3-benzoylphenyl)propanenitrile
Details on test material:
Test item: Ketoprofen I BPPN
Batch Number: F-CHN-080080-01
Chemical name: 2-(3-Benzoyl phenyl)propionitrile
Content: 98.94%
Appearance: Off white powder
TOC: 80.8% (calculated)
Expiry date: 2009-08-12
Recommended storage: Refrigerator, 7 ± 2 °C, protected from moisture and light
Storage at test facility: 6 ± 2 °C, protected from moisture and light
Retention of test item: At least 1 g has been retained.

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Details on inoculum:
Source: Municipal sewage treatment plant, D-31137 Hildesheim
Pretreatment: The activated sludge was washed twice with autoclaved tap water.
After the second washing the settled sludge was filled up with mineral salts medium and was maintained in an aerobic condition by aeration for four hours. Thereafter the sludge was homogenized with a blender. The supernatant was decanted and maintained in an aerobic condition by aeration with C02 free air for 5 days. 10 ml/L were used to initiate inoculation.

Colony forming units in the test vessel: 10^7 - 10^8 CFU/L
Duration of test (contact time):
28 d
Initial test substance concentration
Initial conc.:
15 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
FUNCTIONAL CONTROL
Reference item: Sodium benzoate (FLUKA) 1351586
Batch number: 1351586
CAS No.: 532-32-1
Purity: 100.1%
Expiry date: 2010-02-19
Replicates: Single
Test concentration: 20 mg/L
ThC02: 2.13 mg C02/mg
ThTOC: 0.58 mg C/mg
Carbon content in the vessel: 11.6 mg C/L

TEST ITEM
Ketoprofen / BPPN
Replicates: Duplicates
Test concentration: 15 mg/l
TOC: 0.808 mg C/mg
ThCO2: 2.98 mg C02/mg test item
Carbon content in the vesseI: 12.1 mg C/L
Pretreatment: 15 min ultrasonic treatment at room temperature

TOXICITY CONTROL
Test item and reference item in test concentration
Replicates: Single

INOCULUM CONTROL
Test medium without test and reference item
Replicates: Duplicates

PROCEDURE
Duration: 28 d
Application: Once at test start
Test vessels: 5000 ml, brown glass
Volume of the test medium: 3000 ml
Test medium: Mineral salts medium ace. to OECD 301 B / C02 Evolution Test
Test temperature: 22 ± 2 °C
Dispersion treatment: Continuous stirring
Aeration: 30- 100 ml/min
Photoperiod: Low light conditions


Reference substance
Reference substance:
benzoic acid, sodium salt

Results and discussion

% Degradation
Parameter:
% degradation (CO2 evolution)
Value:
100
Sampling time:
28 d
Details on results:
Toxicity control: biodegradation rate of 56 % was determined within 14 days and it came to 77% after 28 days. The biodegradation of the reference item was not inhibited by the test item.
The 10 % level (beginning of biodegradation) of the test item was reached after 7 days and the pass level of 60 % was reached after 20 days. The biodegradation rate came to 100 % on day 28.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
The test item must be regarded as biodegradable after 28 days.