3-methoxyestra-2,5(10)-dien-17β-ol

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:

Mar - Apr 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:

1997

Report date:

1997

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:

3-methoxyestra-2,5(10)-dien-17β-ol

EC Number:

214-130-2

EC Name:

3-methoxyestra-2,5(10)-dien-17β-ol

Cas Number:

1091-93-6

Molecular formula:

C19H28O2

IUPAC Name:

(1S,3aS,3bR,9bS,11aS)-7-methoxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,6H,9H,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-ol

Details on test material:

- Name of test material (as cited in study report): Dihydro-Estradiol-Methylether
- Analytical purity: 89.7%
- Lot/batch No.: 21400234-35

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.:

0.03 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1: Cumulative mortality (dead fish in percent)

Test dilutions	Concentration (mg/L)	24 hours	48 hours	72 hours	96 hours
ControI	0	0	0	0	0
1:8	0,01	0	0	0	0
1 :4	0,02	0	0	0	0
1 :2	0,03	0	10	20	40
Saturated solution	0,13	10	80	80	100

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The LC50/96 hours of Dihydro-Estradiol-Methylether in Zebra fish was 0.03 mg/L (a confidence limit could not be
calculated). Therefore, the test item is very toxic to fish.

Executive summary:

Ten Zebra fish were used for each of the test solutions and ten for the control group. The fish were exposed to 4 different concentrations of Dihydro-Estradiol-Methylether (1 :8-, 1 :4-, 1 :2-, and the saturated solution) and tap water (controI) for a period of 96 hours. Mortalities and visible abnormalities were recorded at approximately 3, 6, 24, 48, 72 and 96 hours. Samples for the concentration analysis by HPLC were taken at 0, 48 and 96 hours. The mean measured concentrations were 0.13 mg/L (saturated solution) and 0.03 mg/L (1 :2-dilution). The 1 :4- and 1 :8-dilutions of test item were below the detection limit. 100% mortality was observed in the highest test concentration (saturated solution). Furthermore, 40% mortality was the result of exposing the fish to the 1:2 dilution of the saturated solution. No further mortality was observed in the other test concentrations or the control during the whole exposure time.

The LC50/96 hours of Dihydro-Estradiol-Methylether in Zebra fish was 0.03 mg/L (a confidence limit could not be calculated). Therefore, the test item is very toxic to fish.