(trans(trans))-4'-but-3-enyl-4-(4-methylphenyl)-bicyclohexyl

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

ANALOGUE APPROACH JUSTIFICATION
Please refer to the attached read across justification in section 13

Reason / purpose for cross-reference:

read-across source

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

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

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-09-06 to 2000-09-08

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)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

- Reconstituted water according to ELENDT (1990):
Macro nutrients (mg/L): CaCI2 x 7 H20 293.80, MgSO4 x 7H2O 123.30, NaHCO3 64.80, KCI 5.80, Na2SiO3 x 9H2O 10.00, NaNO3 0.27, KH2PO4 0.14, K2HPO4 0.18
Trace elements (mg/L): B 0.5000, Fe 0.2000, Mn 0.1000, Li, Rb and Sr 0.0500, Mo 0.0250, Br 0.0125, Cu and Zn 0.0063, Co and I 0.0025, Se 0.0010, V 0.0003
Macro nutrients (mg/L): Na2EDTA x 2H2O 2.50
Vitamins (µg/L): Thiamine 75.00, B12 1.00, Biotin 0.75
After preparation, the reconstituded water was aerated for 24 hours.
- Hardness: about 14° dH (about 250 mg/L CaCO3)
- pH: 7.9 ± 0.3, after aeration for 24 hours.
References: ELENDT, B.-P. Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus. Protoplasma 154, 25 - 33, 1990

Test organisms (species):

Daphnia magna

Details on test organisms:

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

ACCLIMATION
- Acclimation period: none
- Type and amount of food: a suspension of fresh water algae
- Feeding frequency: one a week

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

14 ° dH (about 250 mg/L CaCO3)

Test temperature:

19 – 20 °C

pH:

7.9 ± 0.3

Dissolved oxygen:

at least 80 %

Nominal and measured concentrations:

A single test item concentration of 100 mg/L was tested in an open static system.
No measured concentration.

Details on test conditions:

-- Preparation: The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test item and vehicle, reconstituted water, was treated in an ultrasonic device for 1 hour. Subsequently the preparation was aerated, and stirred with a magnetic stirrer for further 23 hours. After 24 hours the formulation was given through a nutsch filter (pore size >10 - <16 µm). The filtrate was used for the study.
-- Analysis: No concentration analysis was performed.
-- Environmental conditions: The Daphnia magna were kept in reconstituted water in glass vessels. The study was located in an air-conditioned room. Lighting was controlled by a timer to provide a 16 hours light - 8 hours dark regime. Temperature and humidity in the experimental room were measured using a thermo-hygrograph.
-- Administration: 20 Daphnia per group were exposed in 4 repliates per group, i.e. 5 Daphia per replicate containing 10 mL of reconstituted water (control group) or test medium (test item group). The Daphnia magna were not fed, and the control medium and test medium were not aerated during the test.
-- Concentration levels: A single test material concentration of nominally 100 mg/L was tested in an open static system.
-- Observation schedule: The mobility was determined by visual control and recorded after 24 and 48 hours.
-- pH and oxygen concentration: The pH-values and dissolved oxygen concentration were measured in the control and all test item concentrations at the beginning and at the end of the experimental part.
-- Temperature: During the experimental part, the temperature was registered in a control vessel.

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

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

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

A nominal test concentration of 100 mg/L revealed no aquatic toxicity in this test system.

Validity criteria fulfilled:

yes

Conclusions:

The EC50 (48h) of the test item to Daphnia magna was determined to be > 100 mg/L according to OECD 202 under GLP conditions.

Executive summary:

The objective of this study was to determine the acute toxicity of the test item to Daphnia magna according to OECD 202 (1984) under GLP conditions. 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 vessels per concentration containing five Daphnia magna, i.e. 20 Daphnia per concentration (test medium group). Daphnia magna were exposed to an aqueous solution from a test item concentration of nominal 100 mg/L (limit-test) in an open system. The analysis of a saturated aqueous solution revealed that the water solubility of the test substance was < 0.005 mg/L. Therefore, the test material concentrations in the aqueous medium at the start and the end of the study could not be quantified. After exposure to a saturated aqueous solution of the nominal concentration of 100 mg/L for 48 hours to Daphnia magna a 48-h EC50 >100 mg/L was determined.

Description of key information

The EC50 (48h) of the read-across  test item to Daphnia magna was determined to be > 100 mg/L (reference 6.1.3-1) according to OECD 202 under GLP conditions.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable physicochemical profile and similar data in biological relevant assays. The study was performed according to GLP and the methods applied are fully compliant with OECD TG 202.

 

The objective of this study was to determine the acute toxicity of the test item to Daphnia magna according to OECD 202 (1984) under GLP conditions. 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 vessels per concentration containing five Daphnia magna, i.e. 20 Daphnia per concentration (test medium group). Daphnia magna were exposed to an aqueous solution from a test item concentration of nominal 100 mg/L (limit-test) in an open system. The analysis of a saturated aqueous solution revealed that the water solubility of the test substance was < 0.005 mg/L. Therefore, the test material concentrations in the aqueous medium at the start and the end of the study could not be quantified. After exposure to a saturated aqueous solution of the nominal concentration of 100 mg/L for 48 hours to Daphnia magna a 48-h EC50 >100 mg/L was determined (reference 6.1.3-1).