3'H-Cycloprop[15,16]androsta-6,15-dien-17-one, 3-(2,2-dimethyl-1-oxopropoxy)-15,16-dihydro-5-hydroxy-, (3.beta.,5.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:

Nov- Dec 1998

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:

1999

Report date:

1999

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:

5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one

EC Number:

617-345-3

Cas Number:

82543-14-4

Molecular formula:

C25H36O4

IUPAC Name:

5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one

Details on test material:

- Name of test material (as cited in study report): Enpivalat (ZK 90504)
- Analytical purity: 91.9%
- Lot/batch No.: 21608604

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:

1

Sampling time:

30 d

Details on results:

Degradation reference compound: 87%
Degradation Toxicity control: 45%

Any other information on results incl. tables

Biological degradation (cumulative) in percent (corrected for blank CO2 production) of ZK 90504

Test	Nominal	Day of sampling
compound	concentration   of carbon	4	7	10	11	16	21	25	30
ZK 90504	10 mg/L	0	0	1	1	2	2	1	1
Reference	10 mg/L	26	46	59	65	74	80	84	87
(sodium acetate)
Toxicity control	10 mg/L +	12	22	30	34	38	41	43	45
(ZK 90504 +	10 mg/L
sodium acetate)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

In accordance with the OECO guideline, the test compound ZK 90504 is not readily biodegradable
under the conditions of the test.

Executive summary:

The purpose of this study was to determine the ready biodegradability of Enpivalat (ZK 90504), which is an

intermediate of the drospirenone synthesis. The study was conducted in agreement with the

OECD test guideline no. 301B.

The test substance ZK 90504 was incubated in an aqueous solution including nutrients with microorganisms from a municipal sewage treatment plant for 28 days The test substance ZK 90504 was incubated in a concentration of 10 mg carbon/L in triplicate. The biological degradation of the test and reference substances was evaluated by measurement of the carbon dioxide (CO2) produced during the test period.

The test compound ZK 90504 was degraded to 1 % on day 30 (28 days of incubation). The reference compound sodium acetate was degraded to 87 % on day 30 (28 days of incubation).

In the toxicity control, the reference compound (sodium acetate) plus the test compound ZK 90504 was degraded to 45 % on day 30 (28 days of incubation), thus reflecting the degradation of the test and reference substance incubated individually. The reference compound sodium acetate was degraded to 87 % on day 30 (28 days of incubation).

In accordance with the OECO guideline, the test compound ZK 90504 is not readily biodegradable under the conditions of the test and it was not toxic to the microbes of the activated sludge.