4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin

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:

20 - 24 Jul 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes (incl. QA statement)

Remarks:

Gewerbeaufsicht in Niedersachsen, Staatliches Gewerbeaufsichtsamt Hildesheim, Germany

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control, 100 mg/L
- Sampling method: Samples were taken at 0 and 96 h.
- Sample storage conditions before analysis: All original samples were stored at 6 ± 2 °C. Prepared samples were stored at room temperature in the autosampler until analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test item amount was weighed and applied to the test media in the aquaria. The test media were mixed with an ultraturrax (3 min, 17000 rpm) and aerated for 30 min.
- 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: zebrafish
- Source: Originally supplied from Umweltbundesamt, Berlin, Germany.
- Length at study initiation (length definition, mean, range and SD): 2.24 cm (2.2 - 2.3 cm)
- Weight at study initiation (mean and range, SD): 0.183 g (measurement of all fish together)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Sera vipan, SERA GmbH, Heinsberg, Germany; 4% of fish body weight
- Feeding frequency: 3 times per week; fish were not fed 24 h before start
- Health during acclimation (any mortality observed): Mortality < 5%

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

56.1 mg CaCO3/L (control)

Test temperature:

22.6 - 23.2 °C

pH:

7.31 - 7.57

Dissolved oxygen:

97 - 100%

Nominal and measured concentrations:

nominal: control, 100 mg/L
measured (0 h): < LOQ, 89.7 mg/L
measured (96 h): < LOQ, 91.1 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria
- Material, size, headspace, fill volume: glass, 25.5/18/28 cm (13 L), headspace: 3 L, fill volume: 10 mL
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.128 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Culture medium different from test medium: no
- Intervals of water quality measurement: The pH-value, temperature and oxygen saturation were measured in all test vessels at the start of the exposure and every 24 hours. Total hardness was determined at the start of the exposure out of the control. During the test the water temperature was recorded continuously (once per hour) with a data logger. The light intensity on the surface of the test aquaria was measured at the start of the exposure.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8 h dark
- Light intensity: 7-750 lux

EFFECT PARAMETERS MEASURED
- Mortality: Mortality was recorded after 2, 24, 48, 72 and 96 h.

TEST CONCENTRATIONS
- Range finding study: no

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0%

Sublethal observations / clinical signs:

All effect concentrations were based on the nominal concentrations since the measured concentrations were in the range of > 80 - < 120% of nominal (90 and 91%).

Validity criteria fulfilled:

yes

Conclusions:

No mortality of Danio rerio was observed at the limit concentration of 100 mg/L in a guideline study according to OECD 203 (GLP). Hence, the LC50 (96 h) was derived to be > 100 mg/L (nominal).

Executive summary:

The study was performed according to OECD 203 (GLP). Danio rerio was exposed to a limit concentration of 100 mg/L (nominal) under static conditions. The exposure concentrations were verified by HPLC-DAD analysis and resulted in 90% (0 h) and 91% (96 h) of nominal. Thus, the effect concentrations were based on the nominal concentrations. After a period of 96 h no mortality was recorded in the control and exposure vessels. Hence, the LC50 (96 h) was derived to be > 100 mg/L. All validity criteria were met.

Description of key information

No mortality of Danio rerio was observed at a nominal concentration of 100 mg/L in a guideline study according to OECD 203 (GLP). Hence, the LC50 (96 h) was derived to be > 100 mg/L (nominal).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

One experimental study is available investigating the short-term toxicity of the test substance to fish (2015). The study was performed according to OECD 203 (GLP). Danio rerio was exposed to a limit concentration of 100 mg/L (nominal) under static conditions. The exposure concentrations were verified by HPLC-DAD analysis and resulted in 90% (0 h) and 91% (96 h) of nominal. Thus, the effect concentrations were based on the nominal concentrations. After a period of 96 h no mortality was recorded in the control and exposure vessels. Hence, the LC50 (96 h) was derived to be > 100 mg/L. All validity criteria were met.