3,3-[(2,2-dimethylpropane-1,3-diyl)bis(oxy)]-17α-hydroxyestr-5(10)-ene-17-carbonitrile

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 2000

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:

2001

Report date:

2001

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:

3,3-[(2,2-dimethylpropane-1,3-diyl)bis(oxy)]-17α-hydroxyestr-5(10)-ene-17-carbonitrile

EC Number:

304-925-3

EC Name:

3,3-[(2,2-dimethylpropane-1,3-diyl)bis(oxy)]-17α-hydroxyestr-5(10)-ene-17-carbonitrile

Cas Number:

94291-97-1

Molecular formula:

C24H35NO3

IUPAC Name:

3,3-(2,2-Dimethyltrimethylenedioxy)-17 alpha-hydroxy-5(10)-estrene-17 beta-carbonitrile

Details on test material:

- Name of test material (as cited in study report): Estren-Cyanhydrin-3-Neopentylketal
- Analytical purity: 91.7%
- Lot/batch No.: 1368

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.:

2.2 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Any other information on results incl. tables

No immobilized daphnia were found.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50/48 hours of ZK 30367 to Daphnia magna is higher than a saturated solution
(2.2 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 Estren-Cyanhydrin-3 -Neopentylketal (ZK 30367) with Daphnia magna in order to evaluate the aquatic toxicity. ZK 30367 is an intermediate of the synthesis of cyproteronacetate. The study was conducted as a limit test according to the following guidelines of the 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 aperiod 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 100 mg/L was kept for approximately 30 min in an ultrasonic bath and stirred for 24 hours. This suspension was filtered through a glassfibre filter. The saturated solution obtained by this procedure 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 calculated with 2.2 mg/L.

The EC50/48 hours of ZK 30367 to Daphnia magna is higher than a saturated solution (2.2 mg/L, as determined by TOC analysis).