17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Remarks:

HPLC-UV

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: In the test aquaria, 2.003 g of the test substances were dissolved in 20 L of tap water. This suspension was stirred with three stirrers for a period of about 50 hours. After that, the suspension was filtered using vacuum. The measured pH of this saturated solution was 9.0. Pure tap water was used for the control group and as dilution medium.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish, Danio rerio, Hamilton-Buchanan; Teleostei, Cyprinidae
- Source: Charles Rivers Aquatics, Niederlande, Deutschland-Verleih: Sulzfeld
- Length at study initiation: 1.5-3 cm (estimated)
- Method of breeding: Well-established stock
- Maintenance of the brood fish: The fish were acclimatized for 20 days before start of the test in tap water of the same quality as used for the test. The parameters oxygen content, pH-value and temperature were measured each day. Pre-test mortality: No mortality was observed during the acclimatization period.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

281.52 mg CaCO3/L

Test temperature:

21.0 °C -21.7 °C

pH:

8.2 to 8.5 (control)
8.7 to 8.8 (the saturated solution)

Dissolved oxygen:

7.9mg/L to 9.0 mg/L (90% - 102%)

Details on test conditions:

TEST SYSTEM
- Test vessel: 25 L glass aquaria with 20 L test medium
- Number of organisms per vessel: 10 animals per concentration
- number of vessels per concentration (replicates): 1 vessel
- number of vessels per control (replicates): 1 vessel

TEST MEDIUM/WATER PARAMETERS
- Source/preparation of dilution water: 2.003 g of test substance were added to 20L normal tap water was used as dilution water, not polluted with harmful concentrations of chlorine, heavy metals or other substances, based on quarterly measurements and according to the criteria of the German "Drinking Water Ordinance"
solved.

OTHER TEST CONDITIONS
- Adjustment of pH: 9.0
- photoperiod: 16 h light, 8 h darkness

MEASURED EFFECT PARAMETERS
- Mortality: observed after 2, 24, 48, 72 and 96 h.
- Sublethal effects: Subjective assessments were made of the nature and frequency of sublethal effects compared to control fish at 2, 24, 48, 72 and 96 hours.

Reference substance (positive control):

not required

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1.1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Validity criteria for the measurement of the fish toxicity

Target condition according to guideline:	Actual condition according to the study:	Validity criteria met:
In the control(s) (dilution water control, solvent control), the mortality should not exceed 10% (or one fish, if fewer than 10 control fish are tested) at the end of the exposure.	Mortality of control: 0 fish died	Yes
The dissolved oxygen concentration should be >/= 60% of the air saturation value in all test vessels throughout the exposure period.	The oxygen saturation was measured in a 24 hour interval and ranged between 90% to 102%.	Yes
The concentration of the test item shall be maintained to within 80% of the initial concentration throughout the study. The maintenance of concentration is proved by analytical measurements	In the saturated solution a concentration of about 1.1 mg/L was reached. The test substance was stable over aperiod of 96 hours in water.	Yes
Temperature: the water temperature should not differ by more than 2°C	During the test a temperature range of 21.0 to 21.7 °C was maintained in the test vessels.	Yes
The pH should not vary by more than one unit	During the test, the measured pH values in the test vessels were in the range of 8.7 to 8.8.	Yes
A limit test may be performed at 100 mg/L of the test substance in order to demonstrate that the EC50 is greater than this concentration. The limit test should be performed using at least 7 fish, with the same number in the control. If any mortalities occur, a full study should be conducted.	Within the test, 10 fish were used for the test concentration  and 10 for the control, no mortalities occured.	Yes

 

Validity criteria fulfilled:

yes

Remarks:

See 'Any other information on results incl. tables'

Conclusions:

The detected substance concentration in the saturated solution of the test substance was 1.1 mg/L. No mortality was observed in the test solution. It was demonstrated that the test substance is not toxic to fish within the solubility limits. The LC50 was higher than the maximum water solubility of 1.1 mg/L.

Executive summary:

The study was conducted to assess the acute toxicity of the test substance to zebra fish (Danio rerio) under static conditions. The study was conducted in accordance with the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test'. The detected substance concentration in the saturated solution of the test substance was 1.1 mg/L. No mortality was observed in the test solution. It was demonstrated that the test substance is not toxic to fish within the solubility limits. The LC50 was higher than the maximum water solubility of 1.1 mg/L.

Description of key information

The study was performed to assess the acute toxicity of the test substance to zebra fish (Danio rerio) under static conditions. The study was conducted in accordance with the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test'. The detected substance concentration in the saturated solution of the test substance was 1.1 mg/L. No mortality was observed in the test solution. It was demonstrated that the test substance is not toxic to fish within the solubility limits. The LC50 (96 h) was higher than the maximum water solubility of 1.1 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 1.1 mg/L