Androsta-3,5-dien-17-one, 3-(acetyloxy)-, cyclic 17-(2,2-dimethyl-1,3-propanediyl acetal)

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:

Nov 2001

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:

2003

Report date:

2003

Materials and methods

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(9aR,11aS)-9a,11a-dimethyl-1-oxo-1H,2H,3H,3aH,3bH,4H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-yl acetate

EC Number:

927-431-5

Cas Number:

1178896-82-6

Molecular formula:

C26 H38 O4

IUPAC Name:

(9aR,11aS)-9a,11a-dimethyl-1-oxo-1H,2H,3H,3aH,3bH,4H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-yl acetate

Details on test material:

- Name of test material (as cited in study report): Dienolacetat-ketal
(ZK 67985, 3-Acetoxy-17,17-(2,2-dimethyltrimethylenedioxy)-androst-3,5-diene)
- Analytical purity: 98.6%
- Lot/batch No.: 51537013-021

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Any other information on results incl. tables

The range of the measured dissolved oxygen was between 7.3 and 8.8 mg/L, the temperature was 21.6 to 21.9°C and the pH varied between 7.4 at the beginning and 8.5 at the end of the test. The increase in pH in the control solution was slightly outside the recommended range. This had no effect on the validity of the test.

The organic carbon concentration ofthe 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 fonnula. It was below 1 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50/48 hours of Dienolacetat-ketal to Daphnia magna is >1 mg/L, as determined by TOC analysis.

Executive summary:

The purpose ofthe study was to detennine the acute toxicity (immobilization, EC50/48 hours) of Dienolacetat-ketal (ZK 67985) with Daphnia magna in order to evaluate the aquatic toxicity. Dienolacetat-ketal is an intermediate of the synthesis of drospirenone.

The study was conducted as a limit test according to the following guidelines of the OECD, no 202, and the EC guideline Part 2 - Testing Methods, Part C.2.

20 juvenile Daphnia magna were used for the test solution of Dienolacetat-ketal and 20 for the tap water control. The Daphnia were exposed for aperiod of 48 hours under static conditions. Immobilization was recorded at 24 hours and 48 hours.

The EC50/48 hours of Dienolacetat-ketal to Daphnia magna is expected to be higher than a saturated

solution (> 1 mg/L, as determined by TOC analysis). Therefore, ZK 67985 is not acutely toxic to Daphnia magna.