3'H-Cycloprop[15,16]androst-15-en-17-one, 3-(2,2-dimethyl-1-oxopropoxy)-5,6-epoxy-15,16-dihydro-7-hydroxy-, (3.beta.,5.beta.,6.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:

key study

Study period:

July 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

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:

5,6 beta-Epoxy-7 beta-hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androstan-17-one

EC Number:

617-351-6

Cas Number:

82544-13-6

Molecular formula:

C25 H36 O5

IUPAC Name:

5,6 beta-Epoxy-7 beta-hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androstan-17-one

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 50.6 mg of ZK 90346 were suspended in 500 mL tap water under constant stirring for 24 hours. Thereafter, the solution was filtered through a glassfibre filter. The filtered solution was used as test solution.
- Eluate: no
- Differential loading: yes

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Schering AG, Experimentelle Toxikologie, Berlin, Germany
- Age at study initiation (mean and range, SD): 0-24 h
- 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:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

20.2 - 20.4 °C

pH:

7.6 - 8.6

Dissolved oxygen:

8.0 - 8.4 mg/L

Nominal and measured concentrations:

Measured: 8.5 mg/L (saturated solution)

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.:

> 8.5 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

EC50 (48 h) > 8.5 mg/L (measured, saturated solution)

Executive summary:

The purpose of this study was to determine the acute toxicity (immobilization, EC50 48 hours) of ZK 90346 with Daphnia magna in order to evaluate the aquatic toxicity. The study was conducted as a limit test in agreement with the guideline of the OECD, no. 202, "Daphnia sp., Acute immobilisation test and reproduction test", Part land 11, adopted: 04 Apr. 1984. 20 juvenile Daphnia magna were used for the test solution of ZK 90346 and 20 for the tap water control. The Daphnia were exposed for aperiod of 48 hours under static conditions. Immobilization was recorded at 24 and 48 hours. For the preparation of the test solution, a suspension of 100 mg/L was stirred for 24 hours. This suspension was filtered through a glassfibre filter. The saturated solution obtained by this procedure was used. No immobilized Daphnia was observed in the test solution. The EC50/48 hours of ZK 90346 to Daphnia magna is higher than a saturated solution (8.5 mg/L).