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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:
Oct 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:
Oestr-5(10)-ene-3,17-dione
EC Number:
223-564-1
EC Name:
Oestr-5(10)-ene-3,17-dione
Cas Number:
3962-66-1
Molecular formula:
C18H24O2
IUPAC Name:
(3aS,3bR,9bS,11aS)-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,6H,7H,8H,9H,9bH,10H,11H,11aH-cyclopenta[a]phenanthrene-1,7-dione
Details on test material:
- Name of test material (as cited in study report): Delta-5-Norandrostendion
- Analytical purity: 97.0%
- Lot/batch No.: 12538013

Sampling and analysis

Analytical monitoring:
yes

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 18.7 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility

Any other information on results incl. tables

Table 1: Cumulative immobilization (%) of Daphnia magna (n = 20) after exposure to ZK 67026

 Measured concentration of ZK 67026  24 hours  48 hours  
 (mg/L)      
0 0 0
 Control (tap water)        
1,7 0 0
5,4 0 0
8 0 0
 18,7 (saturated solution)   5 40

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Since a 40% immobilization was reached in the saturated solution (18.7 mg/L) a precise determination ofthe EC50/48 hours of ZK 67026 to Daphnia
magna is not possible. However, it can be extrapolated that this value would most probably be below 100 mg/L. Thus, ZK 67026
can be considered as being slightly toxic to Daphnia magna.
Executive summary:

The purpose ofthe study was to determine the acute toxicity (immobilization, EC50/48 hours) of Delta-5 -Norandrostendion (ZK 67026) with Daphnia magna in order to evaluate the aquatic toxicity. ZK 67026 is an intermediate of the synthesis of the gestagen Dienogest. The study was conducted as a definitive test according to the following guidelines ofthe OECD, no 202.

20 juvenile Daphnia magna were used for each test solution of ZK 67026 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 solutions a suspension with a nominal loading of 100 mg/L was ultrasonified (30 min) and stirred for approximately 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.

Samples for the concentration analysis by TOC were taken at 0 and 48 hours after start of exposure. The calculated results derived from TOC analysis gave mean concentrations of 18.7 mg/L (saturated solution), 8.0 mg/L (1:2 solution), 5.4 mg/L (1:4 dilution), and 1.7 mg/L (1:8 dilution).

40% of the daphnids were imrnobilized at the highest test concentration after 48 h. The highest concentration with no effects was 8.0 mg/L.