Registration Dossier

Administrative data

short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug - Sept 1994
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 Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
Not relevant
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
13-ethyl-3-methoxy-4,6,7,8,9,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-ol (non-preferred name)
Details on test material:
- Name of test material (as cited in study report): Ethyldienol
- Analytical purity: 93.5%
- Lot/batch No.: 15005201

Sampling and analysis

Analytical monitoring:

Test solutions


Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)

Study design

Test type:
Water media type:
Limit test:
Total exposure duration:
48 h

Results and discussion

Effect concentrationsopen allclose all
24 h
Dose descriptor:
Effect conc.:
> 1 - ca. 2 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
24 h
Dose descriptor:
Effect conc.:
1 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1: Effects on behaviour of Zebra fish (n=1 0), exposed to ZK 47.569

 Test concentration of ZK 47,569 (mg/L) nominal    Fish showing total apathy (% of surviving animals)  
    3 hours    6 hours 24 hours
0 0 0 0
1 0 0 0
2 10 10 100
3,6 90 100 100
8,1 90 100 100

Applicant's summary and conclusion

Validity criteria fulfilled:
An LC50 for ZK 47.569 could not be calculated, since no concentration-dependent mortality
was observed in this study but lies between 1 and 2 mg/L. However, clear effects (total apathy
in all fish) were observed after a 24-hour exposure at concentrations of 2.0, 3.6, and 8.1 mg/I
(nominal). The NOEC/24 hours is therefore 1 mg/L.
It is anticipated that the degree of effects and the clear concentration relationship gives
sufficient information on the acute toxicity of ZK 47.569 to fish. A further test over the full test
period of 96 hours is not considered to add relevant information.
Executive summary:

The purpose of this study was to determine the acute toxicity/96 hours of the test compound

Ethyldienol to the Zebra fish (Brachydanio rerio). The study was conducted in agreement with

the test guideline of the OECD, no. 203 "Fish, Acute Toxicity Test".

Ten Zebra fish each were exposed to four concentrations of the test substance and the dilution water for aperiod of 48 hours under flow-through conditions. The test solutions were prepared using 0.2 g Tween 80/L as a vehicle. The same vehicle

concentration was used for the control.

The following nominal test concentrations were selected: 1.0, 2.0, 3.6 and 8.1 mg/L. No chemical analysis was performed. However, it is assumed that under the given flow-through conditions > 80% of the nominal concentration of test compound was maintained taking in account the flow-rate and the hydrolytical stability.

Mortalities and visual abnormalities were recorded at 3, 6, 24, and 48 hours.

The results of the test after 48 hours could not be evaluated due to a technical defect of the

test system. Therefore, only the data related to the 24-hour exposure time are reported.

Mortality (one fish) was observed in the test concentration of 3.6 mg/L within 24 hours.

A concentration- and time-dependent occurrence of total apathy was noted at concentrations

of 2.0 to 8.1 mg/L. Additionafly, two fish were found to have lost equilibrium in the concentration

of 3.6 mg/L. The fish in the control group were free from abnormal effects.