1,4-Dioxaspiro[4.5]decane, 8-[4-(4-methylphenyl)-3-cyclohexen-1-yl]-

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-01-14 to 2004-03-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

April 4, 1984

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

Official Journal No. L 383 A, December 29, 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Remarks:

The water solubility of the test item was 0.006 mg/L using a HPLC method. Due to the low water solubility and the fact that the study was a Iimit test, no further analysis was initiated.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test material and vehicle (reconstituted water) was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. After that the formulation was given through a suction filter (pore size > 10 to < 16 µm) and a single use syringe filter (pore size 0.2 µm). The filtrate was used for the study.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna (Straus)
- Age at study initiation: Daphnia magna, not older than 24 hours
- Source: Merck KGaA, Darmstadt, Institute of Toxicology
- Feeding during test: no

ACCLIMATION
Preparing a new study, juvenile Daphnia magna were separated and placed in 60 ml of reconstituted water. The water was renewed and the Daphnia magna were fed with a Suspension of fresh water algae once a week. New-born animals were separated and allocated to the different dose groups.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

about 14 °dH (about 250 mg/L CaCO3)

Test temperature:

21 °C

pH:

7.88 - 7.94

Dissolved oxygen:

96.3 - 97.1%. The dissolved oxygen concentration was measured in the control and all test material concentrations at the beginning and at the end of the experimental part.

Nominal and measured concentrations:

Nominal concentration: 100 mg/L;
Measured concentration: Due to the low water solubility of the test item (0.006 mg/L) and the fact that the study was performed as a limit test, the test material concentration in the aqueous medium at the start and the end of this study was not quantified.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass test vessels
- Type: open
- Volume of solution: 10 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (ELENDT M4, 1990)
- Culture medium different from test medium: the same
- Intervals of water quality measurement: at the beginning and at the end of the experimental part

OTHER TEST CONDITIONS
- Adjustment of pH: no

EFFECT PARAMETERS MEASURED: the number of immobilized daphnids were recorded after 24-h and 48-h

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: The water solubility of the test item was 0.006 mg/L

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: The water solubility of the test item was 0.006 mg/L

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: The water solubility of the test item was 0.006 mg/L

Details on results:

An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hours EC50 to Daphnia magna exceeded the maximal solubility (0.006 mg/L) of the test material in reconstituted water and, thus, could not be determined in this test.

- Behavioural abnormalities: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no

Results with reference substance (positive control):

Results were not reported in this study.

Validity criteria fulfilled:

yes

Conclusions:

An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC50 for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (0.006 mg/L) and, thus, was determined > 100 mg/L.

Executive summary:

The acute toxicity of the test item to Daphnia magna was assessed in a 48-h Acute Immobilization Test according to OECD TG 202. For this purpose, juvenile Daphnia magna were exposed to an aqueous test material solution over 48 hours, under defined conditions. The study comprised of four test vessels per concentration containing five daphnids each, i.e. 20 daphnids per concentration (test medium group) and control group. Daphnia magna were exposed to a nominal test material concentration of 100 mg/L (limit test) in an open static system. Daphnids exposed to an aqueous preparation of the nominal concentration of 100 mg/L of the test item for 48-h were not affected. The analysis revealed, that the water solubility of the test item was 0.006 mg/L. Because of this low water solubility and the fact that the study was performed as a limit test, the test material concentration in the aqueous medium at the start and the end of this study was not quantified. For the test item, the following EC₅₀ values and no effect concentration for Daphnia magna were determined:

24 h EC₅₀ > 0.006 mg/L (> 100 mg/L nominal concentration)

48hEC₅₀ > 0.006 mg/L (> 100 mg/L nominal concentration)

NOEC ≥ 0.006 mg/L (≥ 100 mg/L nominal concentration)

No effect on the mobility of the daphnia was observed at a nominal concentration of 100 mg/L. The 48 hour EC₅₀ for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (0.006 mg/L) and, thus, was determined > 100 mg/L.

Description of key information

An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC₅₀ for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (0.006 mg/L) and, thus, was determined > 100 mg/L (reference 6.1.3-1).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L

Additional information

The acute toxicity of the test item to Daphnia magna was assessed in a 48-h Acute Immobilization Test according to OECD TG 202. For this purpose, juvenile Daphnia magna were exposed to an aqueous test material solution over 48 hours, under defined conditions. The study comprised of four test vessels per concentration containing five daphnids each, i.e. 20 daphnids per concentration (test medium group) and control group. Daphnia magna were exposed to a nominal test material concentration of 100 mg/L (limit test) in an open static system. Daphnids exposed to an aqueous preparation of the nominal concentration of 100 mg/L of the test item for 48-h were not affected. The analysis revealed, that the water solubility of the test item was 0.006 mg/L. Because of this low water solubility and the fact that the study was performed as a limit test, the test material concentration in the aqueous medium at the start and the end of this study was not quantified. For the test item, the following EC₅₀ values and no effect concentration for Daphnia magna were determined:

24 h EC₅₀ > 0.006 mg/L (> 100 mg/L nominal concentration)

48hEC₅₀ > 0.006 mg/L (> 100 mg/L nominal concentration)

NOEC ≥ 0.006 mg/L (≥ 100 mg/L nominal concentration)

No effect on the mobility of the daphnia was observed at a nominal concentration of 100 mg/L. The 48 hour EC₅₀ for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (0.006 mg/L) and, thus, was determined > 100 mg/L