5H-Dicyclopropa[6,7:15,16]cyclopenta[a]phenanthrene-3,5,17-triol, octadecahydro-17-(3-hydroxy-1-propynyl)-10,13-dimethyl-, (3S,5R,6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-

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:

Nov - Dec 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)

Version / remarks:

no Version available

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol

EC Number:

617-349-5

Cas Number:

82543-17-7

Molecular formula:

C24 H34 O4

IUPAC Name:

21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol

Test material form:

solid: bulk

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): sewage treatment plant Ruhleben
- Storage conditions: room temperature, dark
- Pretreatment: stirred and aerated 2 h

Duration of test (contact time):

28 d

Initial test substance concentration

Initial conc.:

200 mg/L

Based on:

ThOD/L

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

TEST CONDITIONS
- Test temperature: 22 °C
- pH: 7.7 -7.8

TEST SYSTEM
- Number of culture flasks/concentration: 3 replicates

SAMPLING
- Sampling frequency: sampled on day 2, 6, 10, 14, 18, 22, 26, 29

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes, 3 replicates
- Abiotic sterile control: no
- Toxicity control: yes, 1 vessel
- reference substance: yes, 1 vessel

Reference substance

Reference substance:

benzoic acid, sodium salt

Results and discussion

% Degradation

Key result

Parameter:

% degradation (O2 consumption)

Value:

1

Sampling time:

29 d

Details on results:

The test compound Tetrahydropropinol was degraded to 1 % on day 29 (28 days of incubation). In the toxicity control, the reference compound (sodium acetate) plus the test compound ZK 34506, was degraded to 45% on day 29 (28 days of incubation), which reflected the degradation in the individual sets.

BOD5 / COD results

Results with reference substance:

The reference compound sodium acetate was degraded to 70% on day 6 and did not increase until day 29 (28 days of incubation).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

In accordance with the OECD conditions, the test compound Tetrahydropropinol is not readily biodegradable under the conditions of the test and it was not toxic to the microbes of activated sludge.

Executive summary:

The purpose of this study was to determine the ready biodegradability of Tetrahydropropinol (ZK 34506), which is an intermediate of the synthesis of Drospirenone. The study was conducted in agreement with the OECD test guideline no.301F. The test substance was incubated in an aqueous solution including nutrients with microorganisms from a municipal sewage treatment plant for 28 days. The biological degradation of the test and reference substances was evaluated by measurement of the 02 consumption during the test period.

The test compound Tetrahydropropinol was degraded to 1 % on day 29 (28 days of incubation). The reference compound sodium acetate was degraded to 70% on day 6 and did not increase until day 29 (28 days of incubation). In the toxicity control, the reference compound (sodium acetate) plus the test compound, was degraded to 45% on day 29 (28 days of incubation), which reflected the degradation in the individual sets. In accordance with the OECD guideline, the test compound Tetrahydropropinol

is not readily biodegradable under the conditions of the test and it was not toxic to the microbes of activated sludge.