17β-hydroxy-1α-methylandrost-4-ene-3-one

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:

Jul 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline under GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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

Test material information

Constituent 1

Reference substance name:

17β-hydroxy-1α-methylandrost-4-ene-3-one

EC Number:

210-063-8

EC Name:

17β-hydroxy-1α-methylandrost-4-ene-3-one

Cas Number:

604-26-2

Molecular formula:

C20H30O2

IUPAC Name:

17-hydroxy-1-methylandrost-4-en-3-one

Details on test material:

- Name of test material (as cited in study report): 1-Aplha-Methyltestosteron
- Analytical purity: 98.9%
- Lot/batch No.: 21600303

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.:

> 13.4 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

One immobilized Daphnia was observed in the test solution.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50/48 hours of ZK 9227 to Daphnia magna is higher than a saturated solution
(13.4 mg/L). The single immobilized Daphnia is not considered to be substance-related.

Executive summary:

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

of 1 -Methyltestosterone (ZK 9227) with Daphnia magna in order to evaluate the aquatic toxicity.

The study was conducted as a limit test in agreement with the guideline of the OECD, no. 202.

20 juvenile Daphnia mag na were used for the test solution and 20 for the tap water

control. The Daphnia were exposed for aperiod of 48 hours under static conditions. Immobilization was recorded at 24 and 48 hours.

For the preparation of the test solution, 100 mg/L were suspended and stirred for 24 hours.

This suspension was filtered through a glassfibre filter. The saturated solution obtained by this procedure was used as test solution.

The organic carbon concentration of the test solution was analysed with a TOC analyser at the

start of exposure and 48 hours thereafter. The substance concentration was calculated based

on the molecular formula. The concentration was 13.4 mg/L.

One immobilized Daphnia was observed in the test solution.