trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol

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

Study period:

3 Apr - 7 Apr 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No analytical measurements were performed during the study to prove test concentrations. However, the study on water solubility (see 4.8) showed that a sufficient water solubility of 340 g/L is given for the test substance to reach the maximum concentration of 600 ppm that were used within this study. The study on acute toxicity to daphnia magna (see 6.1.3) also indicates that the substance concentration remains constant over 48 h (measured concentration 93-94% of nominal concentration). Furthermore, the study on inherent biodegradability (see 5.2.1 OECD 302 B) showed that only 20% of the test substance were subject to abiotic degradation within 20 days. Therefore, the concentration of the test substance within this study is considered to be sufficient stable and results remain valid.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Please see 'Rationale for reliability incl. deficiencies'

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: To produce the test concentrations a stock solution was prepared by adding 15.0 g of the test substance to 2 L Millipore water which was then diluted in a series to prepare the test solutions.
- Controls: 1 control
- Test concentration separation factor: 1.5 to 2.0

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: reputable supplier
- Weight at study initiation: 0.22 +/- 0.05 g

ACCLIMATION
- Acclimation period: 1 month
- Type and amount of food during acclimation: commercial fish food 0.4 g/ 100 fish
- Feeding frequency during acclimation: daily
- The water was changed with newly performed dilution water (SF No. 30/510) every 6th day.

FEEDING DURING TEST (as applicable)
- Food type: Food is withheld throughout the test period.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

21.4 °C to 22.0 °C

pH:

7.7 to 8.0

Dissolved oxygen:

95 % to 100 %

Nominal and measured concentrations:

nominal concentrations: 0, 50, 100, 200, 400, 600 ppm

Details on test conditions:

TEST SYSTEM
- Test vessel: Each test vessel was filled with 10 L
- Material, size, headspace, fill volume: polyethylene aquaria with a total capacity of 20 L and a surface area of 800 cm2
- Aeration: test vessels were aerated gently
- No. of organisms per vessel: 10 fish
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: newly produced dilution water (SF 30/510)
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Photoperiod: daily light/dark period 14:10 h

EFFECT PARAMETERS MEASURED
- Mortalities are recorded after 2, 24, 48, 72 and 96 hours.
- Additional observation of symptoms: swimming behavior, loss of equilibrium, seek to the bottom, respiration, pigmentation

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.5 to 2.0
- Range finding study: test concentrations were selected on the basis of a preliminary rankfinding test (results not reported)
- Test concentrations: 0, 50, 100, 200, 400, 600 ppm

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (K2Cr2O7)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 600 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC10

Effect conc.:

> 600 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Other adverse effects control: 0%
- Mortality of control: 0%
- Abnormal responses: after 24 h one fish seek to bottom in the 100, 200, 400 and 600 ppm concentration replicate and after 72 h and 96 h one fish seek to bottom in the 600 ppm concentration replicate.

Results with reference substance (positive control):

LC50 was found to be 330 mg/L for the reference substance Potassium dichromate (K2Cr2O7)

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 95% to 100%.	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	No analytical measurements were performed during the study to prove test concentrations.	No
Temperature: the water temperature should not differ by more than 2°C	During the test a temperature range of 21.4 to 22.0°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 7.7 to 8.0.	Yes

 

Validity criteria fulfilled:

no

Remarks:

See 'Any other information on results incl. tables'.

Conclusions:

No toxic effects of the test substance against fish up to 600 ppm (nominal concentration) were observed; LC50(96h)>600 ppm (nominal concentration).

Executive summary:

The study was performed to assess the acute toxicity of the test substance to zebra fish (Danio rerio former Brachydanio rerio) under static conditions. The study was conducted according to OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test'. Groups of ten fish were exposed to five test concentrations (50, 100, 200, 400, and 600 ppm), a control treatment and treatment with the reference substance Potassium dichromate. Observations were made on the number of dead fish and additional adverse symptoms after 24, 48, 72, and 96 hours of exposure. The following values were determined: LC50(96h)>600 ppm (nominal concentration). No analytical measurements were performed during the study to prove test concentrations. However, the study on water solubility (see 4.8) showed that a sufficient water solubility of 340 g/L is given for the test substance to reach the maximum concentration of 600 ppm that were used within this study. The study on acute toxicity to daphnia magna (see 6.1.3) also indicates that the substance concentration remains constant over 48 h (measured concentration 93-94% of nominal concentration). Furthermore, the study on inherent biodegradability (see 5.2.1 OECD 302 B) showed that only 20% of the test substance were subject to abiotic degradation within 20 days. Therefore, the concentration of the test substance within this study is considered to be sufficient stable and results remain valid.

Description of key information

The study was performed to assess the acute toxicity of the test substance to zebra fish (Danio rerio former Brachydanio rerio) under static conditions. The study was conducted according to OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test'. Groups of ten fish were exposed to five test concentrations (50, 100, 200, 400, and 600 ppm), a control treatment and treatment with the reference substance Potassium dichromate. Observations were made on the number of dead fish and additional adverse symptoms after 24, 48, 72, and 96 hours of exposure. The following values were determined: LC50(96h)>600 ppm (nominal concentration). No analytical measurements were performed during the study to prove test concentrations. However, the study on water solubility (see 4.8) showed that a sufficient water solubility of 340 g/L is given for the test substance to reach the maximum concentration of 600 ppm that were used within this study. The study on acute toxicity to daphnia magna (see 6.1.3) also indicates that the substance concentration remains constant over 48 h (measured concentration 93-94% of nominal concentration). Furthermore, the study on inherent biodegradability (see 5.2.1 OECD 302 B) showed that only 20% of the test substance were subject to abiotic degradation within 20 days. Therefore, the concentration of the test substance within this study is considered to be sufficient stable and results remain valid.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 600 mg/L