Registration Dossier

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:
other information
Study period:
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:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 34517 (3ß,5-Dihydroxy-6ß,7ß; 15ß, 16ß-dimethylene-5ß-androstan-17 -one)
- Analytical purity: 96.1-97.9%
- Lot/batch No.: 27002001-07 (mixed charge)

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
Total exposure duration:
48 h

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
38.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 33.1-45.7

Any other information on results incl. tables

The test temperature was in the range of 20.3 to 20.6 °C, the pH ranged between 7.9 and 8.6, and the oxygen concentration between 8.8 and 9.7 mg/L. The light/dark rhythm was adjusted to 12 hours/12 hours.

Applicant's summary and conclusion

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