5H-Dicyclopropa[6,7:15,16]cyclopenta[a]phenanthrene-3,5,17-triol, octadecahydro-17-(3-hydroxypropyl)-10,13-dimethyl-, (3S,5R,6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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:

17 alpha-(3-Hydroxypropyl)-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstane-3 beta,5,17 beta-triol

EC Number:

617-350-0

Cas Number:

82543-18-8

Molecular formula:

C24 H38 O4

IUPAC Name:

17 alpha-(3-Hydroxypropyl)-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstane-3 beta,5,17 beta-triol

Test material form:

solid

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 100 mg ZK 92836 were suspended in 1000 mL tap water under constant stirring for approximately 24 hours. Thereafter, the solution was filtered through a glassfibre filter. The filtered solution was used as test solution.
- Differential loading: yes

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Age at study initiation (mean and range, SD): 0-24 h
- Source: Schering AG, Experimental Toxicology, Berlin, Germany
- Feeding during test: no
- Holding: Parent animals were kept in glass vessels in water of the same quality and temperature as under experimental conditions. The animals were continuously fed with a laboratory culture of microalgae, e.g. Chlorella vulgaris.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

20.6 - 20.7 °C

pH:

7.3 - 8.5

Dissolved oxygen:

7.8 - 8.8 mg/L

Nominal and measured concentrations:

nominal: 100 mg/L
measured: 50.24 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL vessels
- Volume of solution: 50 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline

OTHER TEST CONDITIONS
- Photoperiod: 12 h light/12 h darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
- Mobility after 24 and 48 h

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 50.2 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 92836

Concentration of ZK 92836 (mg/L)	24 hours	48 hours
0 control (tap water)	0	0
Saturated solution	0	0

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50/48 hours of ZK 92836 to Daphnia magna is expected to be higher than a saturated solution (50.2 mg/L, as determined by TOC analysis).

Executive summary:

The purpose ofthe study was to determine the acute toxicity (irnmobilization, EC50/48 hours) of Dimethylenpropanol (ZK 92836) with Daphnia magna in order to evaluate the aquatic toxicity. ZK 92836 is an intermediate of the synthesis of Drospirenone. The study was conducted as a limit test according to the following guidelines ofthe OECD, no 202.

20 juvenile Daphnia magna were used for the test solution of ZK 92836 and 20 for the tap water control. The Daphnia were exposed for aperiod of 48 hours under static conditions. Irnmobilization 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 ofthe test solution was analyzed with a TOC analyzer for samples taken at the start of exposure and 48 hours thereafter. The mean concentration was calculated with 50.2 mg/L.

The EC50/48 hours of ZK 92836 to Daphnia magna is expected to be higher than a saturated solution (50.2 mg/L, as determined by TOC analysis).