Registration Dossier

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: 2008-10-23 - Experimental completion: 2009-02-13
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:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test item: Ketoprofen / CFPPN
Batch number: F-PPR-080059
CAS RN: 42872-29-7
Chemical name: 3-(1-Cyanoethyl)benzoyl chloride
Content: 95.0%
Carbon content in the vessel : 11.8 mg C/L
Appearance: Brown liquid
Sum formula: C10H8ClNO
Molecular weight: 193.63 g/mol
Water solubility: Hydrolyses at 20 °C
TOC: 58.93% (calculated)
Expiry date: 2009-08-12
Recommended storage: Refrigerator, 7 ± 2 °C, protected from moisture and light
Storage at test facility: 6 ± 2 oc, protected from moisture and Iight
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 2 days. 10 ml/L were used to initiate inoculation.

Colony forming units in the test vesseI: 10^7 - 10^8 CFU/L
Duration of test (contact time):
28 d
Initial test substance concentrationopen allclose all
Initial conc.:
20 mg/L
Based on:
test mat.
Initial conc.:
0.589 other: C/mg
Based on:
other: TOC
Initial conc.:
2.17 other: mg CO2/mg
Based on:
other: ThCO2
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
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 I C02 Evolution Test
Test temperature: 21.0- 23.5 °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

% Degradationopen allclose all
Parameter:
% degradation (CO2 evolution)
Value:
10
Sampling time:
18 d
Parameter:
% degradation (CO2 evolution)
Value:
25
Sampling time:
28 d
Details on results:
Toxicity control: biodegradation rate of 56 % was determined within 14 days and it came to 73% 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 a long lasting adaptation phase of 18 days. In the further course, the biodegradation increased slowly and on day 28 a mean biodegradation rate of 25% was reached.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
not inherently biodegradable
Conclusions:
The test item must be regarded as not readily biodegradable in the 10-d-window and after 28 days.