tert-butyl {(1S,3S)-3-{(S)- hydroxy[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methyl-1-[ (2S,4S)-5-oxo-4-(propan-2-yl)tetrahydrofuran-2-yl ]pentyl}carbamate

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:

13-aug-2007 to 11-sep-2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl N-[(1S,3S,4S)-4-hydroxy-4-[4-methoxy-3-(3-methoxypropoxy)phenyl]-1-[(2S,4S)-5-oxo-4-(propan-2-yl)oxolan-2-yl]-3-(propan-2-yl)butyl]carbamate

EC Number:

700-317-0

Cas Number:

934841-33-5

Molecular formula:

C30H49NO8

IUPAC Name:

tert-butyl N-[(1S,3S,4S)-4-hydroxy-4-[4-methoxy-3-(3-methoxypropoxy)phenyl]-1-[(2S,4S)-5-oxo-4-(propan-2-yl)oxolan-2-yl]-3-(propan-2-yl)butyl]carbamate

Details on test material:

- Name of test material (as cited in study report): SPP100 C6
- Substance type: White, fine-crystallic powder
- Physical state: Solid
- Stability under test conditions: Not indicated
- Storage condition of test material: Stored at ambient temperature
- Analytical purity: 99.2%
Significant impurities: Sum of all impurities by HPLC: 0.8%
Solvent content: Isopropyl acetate (CAS No. 108-21-4): 1.9% (w/w)
Methylcyclohexane (CAS 108-87-2): 5.8% (w/w)
- Lot/batch No.: HH-853.35Kr
- Expiration date of the lot/batch: December 2007

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

other: Secondary effluent of the waste water treatment plant

Details on inoculum:

Source
- The source of test organisms was secondary effluent freshly obtained from a municipal sewage treatment plant: 'Pardbice, Czech, receiving predominantly domestic sewage.

Treatment
- Secondary effluent was filtered through a paper filter. COD was determined and the filtrate was kept aerated until inoculation.

Inoculation
- 2.1 ml filtrate of secondary effluent per litre of final volume.

Duration of test (contact time):

28 d

Initial test substance concentration

Initial conc.:

3.31 mg/L

Based on:

other: COD (Chemical oxygen demand)

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

TEST CONDITIONS
- Composition of medium:
1 litre mineral medium contains: 1 ml of solution (A) to (D) and Milli-RO water
Stock solutions of mineral components
A) 8.50 g KH2PO4; 21.75 g K2HPO4; 33.40 g Na2HPO4.2H2O; 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) 27.50 g CaCl2 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: between 20 ± 1.0°C
- pH: At the start of the test: 7.4
- pH adjusted: no
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus: approx. 280 ml BOD bottles with glass stoppers
- Number of culture flasks/concentration: 2 flasks per measuring point
- Test performed in open system: no

SAMPLING
- Sampling frequency: In duplicate; immediately at the start of the experiment (day 0), and on day 3, 7, 10, 14, 17, 21, 24 and 28
- Sampling method: Whole flask was used for measurement

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Procedure control: reference substance
- Toxicity control: yes, test substance, reference substance and inoculum

Reference substance

Reference substance:

other: sodium benzoate

Results and discussion

% Degradation

Parameter:

% degradation (O2 consumption)

Value:

11

Sampling time:

28 d

BOD5 / COD results

Results with reference substance:

The reference substance was degraded by at least 60% (85%) within 14 days .

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

The test substance , SPP100 C6, is not ready biodegradble.