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.)-

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

other information

Study period:

May 1999

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 202 (Daphnia sp. Acute Immobilisation 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

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 2.3 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Any other information on results incl. tables

Cumulative immobilization (%) of Daphnia magna (n=20) after exposure to ZK 90506

Concentration of ZK 90506	24 hours	48 hours
(mg/L)
	0	0
control (tap water)
Saturated solution	0	5

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50/48 hours of ZK 90506 to Daphnia magna is expected to be higher than a saturated
solution (2.3 mg/L, as determined by TOC analysis).

Executive summary:

The purpose of the study was to determine the acute toxicity (immobilization, EC50/48 hours) of Methylenpivalat (ZK 90506) with Daphnia magna in order to evaluate the aquatic toxicity. ZK 90506 is an intermediate of the synthesis of Drospirenone. The study was conducted as a limit test according to the guideline of the OECD, no 202.

20 juvenile Daphnia magna were used for the test solution of ZK 90506 and 20 for the tap water contro!. The Daphnia were exposed for aperiod of 48 hours under static conditions. Immobilization was recorded at 24 hours and 48 hours. For the preparation of the test solution, a suspension with a nominal loading of 100 mg/L was stirred for 24 hours. The saturated solution obtained by this procedure was used. The organic carbon concentration of the test solution was analyzed with a TOC analyzer at the start of exposure and 48 hours thereafter. The substance concentration was calculated on the basis of the molecular formula. The mean concentration was calculated with 2.3 mg/L.

After 48 hours, five out of 20 Daphnids in the saturated solution were immobilized. The EC50/48 hours of ZK 90506 to Daphnia magna is expected to be higher than a saturated solution (2.3 mg/L, as determined by TOC analysis).