3'H-Cycloprop[15,16]androsta-5,15-dien-17-one, 3-(2,2-dimethyl-1-oxopropoxy)-15,16-dihydro-7-hydroxy-, (3.beta.,7.beta.,15.alpha.,16.alpha.)-

Biodegradation in water: screening tests

Administrative data

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

other information

Study period:

Aug-Sept 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

7 beta-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5-androsten-17-one

EC Number:

617-344-8

Cas Number:

82543-09-7

Molecular formula:

C25 H36 O4

IUPAC Name:

7 beta-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5-androsten-17-one

Details on test material:

- Name of test material (as cited in study report): Methylenpivalat (ZK 90506)
- Analytical purity: 98.8%
- Lot/batch No.: 14634001

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic (adaptation not specified)

Duration of test (contact time):

28 d

Initial test substance concentration

Initial conc.:

10 mg/L

Based on:

test mat.

Results and discussion

% Degradation

Parameter:

% degradation (CO2 evolution)

Value:

5

Sampling time:

29 d

Details on results:

Degradation Reference compound: 88%
Degradation toxicity control: 47%

Any other information on results incl. tables

Biological degradation in percent (corrected for blank C02 production) of ZK 90506

		nominal
Test compound	Concentration of carbon	4	7	11	15	20	25	29
ZK 90506	10 mg/L	1	0	0	0	1	3	5
Reference (sodium acetate)	10 mg/L	31	55	68	75	82	85	88
T oxicity control (ZK 90506 + sodium acetate)	10 mg/L + 10 mg/L	15	26	34	39	43	45	47

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

In accordance with the OECD guideline, the test compound ZK 90506 is not readily biodegradable under the conditions of the test.

Executive summary:

The purpose of this study was to determine the ready biodegradability of Methylenpivalat (ZK 90506,) which is an intermediate of the synthesis of Drospirenone. The study was conducted in agreement with the OECD test guideline no. 301 B.

The test substance ZK 90506 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 carbon dioxide (C02) produced during the test period.

The test compound ZK 90506 was degraded to 5 % on day 29 (28 days of incubation). The reference compound sodium acetate was degraded to 88 % on day 29 (28 days of incubation). In the toxicity control, the reference compound (sodium acetate) plus the test compound ZK 90506, was degraded to 47 % on day 29 (28 days of incubation). Accordingly, the test compound ZK 90506 is not readily biodegradable under the conditions of the test and it was not toxic to the microbes of activated sludge.