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Diss Factsheets

Ecotoxicological information

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:
Nov 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
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

Constituent 1
Chemical structure
Reference substance name:
3 beta,5-Dihydroxy-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstan-17-one
EC Number:
617-347-4
Cas Number:
82543-16-6
Molecular formula:
C21 H30 O3
IUPAC Name:
3 beta,5-Dihydroxy-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstan-17-one
Test material form:
solid

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: all concentrations at the time point 0 (measured vessel) and 48 hours (all test vessels, pooled) after start of exposure.
- Sampling method: One sample was taken at each time point.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: For the preparation of the test solutions a suspension with a nominal loading of 100 mg/L was treated in an ultrasonic bath for 30 min. and thereafter stirred tor 24 hours. This suspension was filtered through a glassfibre filter. The resulting solution served as the highest concentration (saturated solution). It was further diluted 1:2, 1:4, and 1:8.
- Eluate: no
- Differential loading: no
- Controls: 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
- Feeding during test : no

Study design

Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h

Test conditions

Test temperature:
20.3 - 20.6 °C
pH:
7.9 - 8.6
Dissolved oxygen:
8.8 - 9.7 mg/L
Nominal and measured concentrations:
nominal: 100 mg/L dilutions of 1:2, 1:4, 1:8
mean measured: 46.61, 21.92, 11.95, 5.58 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL test vessels
- Volume of solution: 45 mL
- 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):
- Immobilization and visual abnormalities were recorded at 24 and 48 hours.
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
38.6 mg/L
95% CI:
>= 33.1 - <= 45.7
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Reported statistics and error estimates:
The EC50 for the compound was calculated by the computer program "Probit-Analyse" (version 1.2), Institute of Biometrics, Schering AG, Berlin, Germany.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The EC50 (48 h) of Dimethylenketon (ZK 34517) to Daphnia magna was calculated to be 38.6 mg/L [95% confidence limits 33.1 - 45.7 mg/L] on the basis of TOC analysis. The highest concentration with no effects was 5.6 mg/L.
Executive summary:

The purpose of the study was to determine the acute toxicity (immobilization, EC50/48 hours) of Dimethylenketon with Daphnia magna in order to evaluate the aquatic toxicity. Dimethylenketon is an intermediate of the synthesis of drospirenone. The study was conducted as a definitive test according to the following guidelines of the OECD, no 202, and the EC guideline 92/69/EEC.


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


Immobilized Daphnia were observed in the test concentrations 12.0, 21.9 and 46.6 mg/L. The EC50/48 hours of Dimethylenketon to Daphnia magna was calculated to be 38.6 mg/L [95% confidence limits: 33.1-45.7 mg/L] on the basis of TOC analysis. The highest concentration with no effects was 5.6 mg/L.