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

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec 1995 - Mar 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 203 (Fish, Acute Toxicity 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):

Danio rerio (previous name: Brachydanio rerio)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.7 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 2.2 - 3.6 mg/L

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1: Mortality of Zebra fish (Brachydanio rerio) after 96 hours exposure to ZK 9340 (n=10)

Concentration of ZK9340	3 hours	6 hours	24 hours	48 hours	72 hours	96 hours.
(mg/I)
control	0	0	0	0	0	0
0,5	0	0	0	0	0	0
0,9	0	0	0	0	0	0
1,8	0	0	1	1	1	3
3,8	0	3	7	7	8	8

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The LC50/96 hours of ZK 9340 in Zebra fish was 2.7 mg/L (95% confidence limits: 2.2-3.6 mg/L).
The results ot this study showed that ZK 9340 is toxic to fish.

Executive summary:

The purpose o·f this study was to determine the acute toxicity (LC50/96 hours) of the substance M-DOC (ZK 9340) to Zebra fish Brachydanio rerio. ZK 9340 is an intermediate in the synthesis of fluocortolone.

Ten Zebra fish (Brachydanio rerio) were used for each of the test solutions and ten tor the control group. The fish were exposed to 4 different concentrations of the test substance (1 :80, 1 :40, 1 :20 and 1:10 dilution of a saturated solution) and the dilution water for aperiod of 96 hours. The test solution was prepared by suspending 100 mg/L of test substance and making appropriate dilutions of the filtrate after 24 hours stirring. Mortalities and visible abnormalities were recorded at approximately 3, 6, 24, 48, 72 and 96 hours. Samples tor the analysis by HPLC with UV detection were taken at 0, 48 and 96 hours.

The mean measured concentrations were 3.8 mg/L (1 :10 of the saturated solution), 1.8 mg/L (1:20),0.9 mg/L (1 :40) and 0.5 mg/L (1:80).

80% mortality was observed in the highest test concentration of 3.8 mg/L. Furthermore, 30% mortality was the result of the exposure of the fish at 1.8 mg/L. No further mortality was observed in the remaining test concentrations and the control during the whole exposure time. All the fish in the 4 test dilutions were slightly less active in comparison to the control group.