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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:
Dec 2002 - Jan 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to oECD guideline under GLP
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Principles of method if other than guideline:
not relevant
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
17 alpha-Cyanomethyl-17 beta-hydroxy-5(10)-estren-3-one
EC Number:
613-855-5
Cas Number:
65928-65-6
Molecular formula:
C20 H27 N O2
IUPAC Name:
17 alpha-Cyanomethyl-17 beta-hydroxy-5(10)-estren-3-one
Details on test material:
- Name of test material (as cited in study report): 5-Dehydrocyanomethylketon
- Analytical purity: 94.1%
- Lot/batch No.: 21043011

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
Limit test:
yes
Total exposure duration:
48 h

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 20.8 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Saturated solution

Any other information on results incl. tables

There was no substance related immobilization. The single immobilized Daphnia in the control group is within the limit (10%) accepted by the OECD guideline.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The EC50/48 hours of ZK 37877 to Daphnia magna is expected to be higher than a saturated solution (20.8 mg/L, as determined by TOC analysis).
Executive summary:

The purpose of the study was to determine the acute toxicity (immobilization, EC50/48 hours) of 5 -Dehydrocyanomethylketon (ZK 37877) with Daphnia magna in order to evaluate the aquatic toxicity. ZK 37877 is an intermediate of the synthesis of dienogest. 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 and 20 for the tap water control. The Daphnia were exposed for a period of 48 hours under static conditions. Immobilization was recorded at 24 hours and 48 hours. For the preparation of the test solution, a suspension with a nominal loading of 125 mg/L was stirred for 24 hours after ultrasonification. This suspension was filtered through a glassfibre filter. The solution obtained by this procedure was used for the test solution. It was considered to be saturated under the conditions of this test. The organic carbon concentration of the test solution was analyzed with a TOC analyzer with samples taken at the start of exposure and 48 hours thereafter. The substance concentration was calculated on the basis of the molecular formula. The mean concentration was calculated with 20.8 mg/L.

There was no substance related immobilization.