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EC number: 616-391-1 | CAS number: 76812-02-7
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:
- Start of the experimental part: 19-09-1997 / End of experimental part: 17-10-1997
- 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:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Qualifier:
- according to guideline
- Guideline:
- other: DIN-EN 29439 (1993)
- Qualifier:
- according to guideline
- Guideline:
- ISO DIS 9439 (Ultimate Aerobic Biodegradability - Method by Analysis of Released Carbon Dioxide)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 616-391-1
- Cas Number:
- 76812-02-7
- Molecular formula:
- C34 H41 N O4
- IUPAC Name:
- 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- Reference substance name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- IUPAC Name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- Details on test material:
- - Name of test material (as cited in study report): Fexofenadonethylester
- Exact characterization: 4-[4-[4-hydroxydiphenylmethyl]-1-piperidinyl]-1-oxobutyl]-a,a-dimethylbenzeneacetic acid ethyl ester
- Code: HOE-CG-Nr. 0529 OY ZD99 0001
- Synonyme: Terfenadonethylester
- Solubility in water: Not soluble in water
- Purity: 98.65 % (w/w)
- Impurities: Azacyclonol [115-46-8]; p-Cyclopropylketon [169280-10-8]
- Lot/batch No.: TAM 40-96-13 of 27.08.96
- Expiration date of the lot/batch: 27.08.1998
- Stability in water solution: 96 h
- Date of delivery (test substance): 28.08.1997
Constituent 1
Constituent 2
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- sewage, predominantly domestic, non-adapted
- Details on inoculum:
- Origin: Sewage treatment plant at Frankfurt am Main-Sindlingen
Type of inoculum: Domestic sewage sludge
Preparation of the suspension: Sediment from activated sewage sludge was washed two times by centrifuging and resuspending in mineral medium.
Amount used: 10 ml/l sludge suspension
Content of sludge sediment: 16 g/l
Content of suspended solids: 2.2 g/l (dry matter)
Content in the final test volume: 22 mg/l (dry matter)
Pretreatment: Aerated for a period of 7 days to reduce the internal carbon content of the sewage sludge.
State of adaptation: Not pre-adapted to the reference or test substance. - Duration of test (contact time):
- 28 d
- Details on study design:
- Reaction vessel: 5L glass flasks with magnetic stirrers, aerated by the passage of C02-free air. The outgoing air was passed through three traps, each filled with 100 ml 0.0125 M Ba(OH)2 to catch the C02 produced.
Sampling: 20 ml each from the C02-traps for titration
Temperature: thermostatically controlled at 22°C ± 1°C. During the test period the temperature remained in the range between 21°C and 23°C.
Reference substance
- Reference substance:
- benzoic acid, sodium salt
Results and discussion
% Degradation
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 3
- Sampling time:
- 28 d
BOD5 / COD results
- Results with reference substance:
- The degradation of the reference substance caused a CO2 formation of more than 60% within 14 days.
The C02 generated in the blank controls remained below 40 mg/l (10.9 mg C/l).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- under test conditions no biodegradation observed
- Conclusions:
- Fexofenadonethylester is not readily biodegradable under the conditions of this test. Significant biodegradation was not detected.
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