Pregn-4-ene-3,20-dione, 21-hydroxy-16-methyl-, (16.alpha.)-

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:

Nov - Dec 1995

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:

21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione

EC Number:

609-766-6

Cas Number:

39987-86-5

Molecular formula:

C22 H32 O3

IUPAC Name:

21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): M-DOC
- Analytical purity: 98.2%
- Lot/batch No.: 34514021

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:

no

Total exposure duration:

48 h

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

5.6 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 4.1 - 7.8 mg/L

Any other information on results incl. tables

Table 1: Cumulative immobilization (%) of Daphnia magna after exposure to ZK 9340

Concentration of ZK 9340	24 hours	48 hours
0,0 mg/I	5	10
1,1 mg/I	0	15
2,2 mg/I	0	30
4,6 mg/I	0	30
8,6 mg/I	15	35
18,6 mg/I	15	100
38,6 mg/I	100	100

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50/48 hours of ZK 9340 to Daphnia magna was calculated to be 5.6 mg/L
[95% confidence limits 4.1-7.8 mg/L]. Accordingly, ZK 9340 is toxic to Daphnia magna.

Executive summary:

The purpose of this study was to determine the acute toxicity (immobilization, EC50/48 hours) of M-DOC (ZK 9340) to Daphnia magna. 20 Daphnia were used for each of the six test concentrations of the test substance and for the dilution water control. The Daphnia were exposed to the test solutions and the dilution water for a period of 48 hours under static conditions. The test solutions were a saturated solution and 5 dilutions thereof (by a factor of 2).

Sampies for analysis by HPLC were taken at 0 and 48 hours. The concentrations of the test solutions according to analysis were 0, 1.1, 2.2, 4.6, 8.6, 18.6 and 38.6 mg/L. Immobilization was recorded at 24 hours and 48 hours. The cumulative immobilization (%) is summarized in the following table. An increasing number of immobilized Daphnia was observed in the test solutions up to 100% in a concentration of 18.6 mg/L.

The EC50/48 hours of test substance to Daphnia magna was calculated to be 5.6 mg/L [95% .confidence limits 4.1-7.8 mg/L]. Accordingly, M-DOC is toxic to Daphnia magna.