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.)-

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:

Oct-Nov 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:

1998

Report date:

2001

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:

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

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.:

> 3.8 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 after exposure to ZK 90504
Concentration of	Total no. of Daphnia	No. of immobilized Daphnia
ZK 90504		24 hours	48 hours
Control (tap water)	20	0	0
Saturated solution 3.8 mg/L	20	3	4

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

ZK 90504 has a low short-term toxicity to Daphnia magna

Executive summary:

The purpose of the study was to determine the acute toxicity (immobilization, EC50 48 hours) of

Enpivalat (ZK 90504) with Daphnia magna in order to evaluate the aquatic toxicity. ZK 90504 is an intermediate of the synthesis of drospirenone. The study was conducted as a limit test according to the OECD guideline no 202.

The Daphnia were exposed for a period of 48 hours under static conditions. Immobilization was recorded at 24 hours and 48 hours.

For the preparation of the test solutions, a suspension with a nominal loading of 100 mg/L (saturated solution) 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 3.8 mg/L.

After 48 hours, four immobilized Daphnia were observed in the saturated solution.

The TOC measurement indicated that ZK 90504 was only slightly soluble under the test conditions. ZK 90504 affected up to 20% of the test animals. Therefore the EC50/48 hours of ZK 90504 to Daphnia magna is expected to be higher than a saturated solution (3.8 mg/L).It can be concluded that ZK 90504 has a low short-term toxicity to Daphnia magna.