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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:
other information
Study period:
Oct-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:
2001

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:
5-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androst-6-en-17-one
EC Number:
617-345-3
Cas Number:
82543-14-4
Molecular formula:
C25 H36 O4
IUPAC Name:
5-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androst-6-en-17-one
Details on test material:
- Name of test material (as cited in study report): Enpivalat (ZK 90504)
- Analytical purity: 91.9%
- Lot/batch No.: 21608604

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.:
> 3.8 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility

Any other information on results incl. tables

 Cumulative immobilization of Daphnia magna after exposure to ZK 90504  
 Concentration of    Total no. of Daphnia    No. of immobilized Daphnia    
 ZK 90504       24 hours    48 hours    
 Control (tap water)   20 0 0  
          
 Saturated solution 3.8 mg/L 20 3 4  

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
ZK 90504 has a low short-term toxicity to Daphnia magna
Executive summary:

The purpose of the study was to determine the acute toxicity (immobilization, EC50 48 hours) of

Enpivalat (ZK 90504) with Daphnia magna in order to evaluate the aquatic toxicity. ZK 90504 is an intermediate of the synthesis of drospirenone. The study was conducted as a limit test according to the OECD guideline no 202.

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 (saturated solution) was used.

The organic carbon concentration of the test solution was analyzed with a TOC analyzer 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 3.8 mg/L.

After 48 hours, four immobilized Daphnia were observed in the saturated solution.

The TOC measurement indicated that ZK 90504 was only slightly soluble under the test conditions. ZK 90504 affected up to 20% of the test animals. Therefore the EC50/48 hours of ZK 90504 to Daphnia magna is expected to be higher than a saturated solution (3.8 mg/L).It can be concluded that ZK 90504 has a low short-term toxicity to Daphnia magna.

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