Ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study in compliance with GLP-criteria.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl trans-(±)-2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate hydrochloride

EC Number:

248-226-0

EC Name:

Ethyl trans-(±)-2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate hydrochloride

Cas Number:

27107-79-5

IUPAC Name:

27107-79-5

Details on test material:

- Substance name: Trans-Tilidin-HCl-Hemihydrate
- Aggregate state/colour: solid/white
- Homogeneity: homogeneous
- Storage conditions: at room temperature under nitrogen atmosphere and light exclusion

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

At the begin (t=0h) and at the end of the exposition (t=48h) samples were taken from vessels without daphnids.

Test solutions

Details on test solutions:

The test substance was stirred in M4 medium for about 10 minutes at 20 ±2 °C. The nominal concentration of the stock solution was 100 mg/L. Test concentrations were prepared by by diluting the stock solution with M4 medium.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquee, France, in 1978. From this date on this clone was cultured and bred continuously in the Laboratory Experimental Toxicology and Ecology of BASF AG in Ludwigshafen.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

2.48 mmol/L

Test temperature:

19.6 - 20.3 °C

pH:

7.9 - 8.2

Dissolved oxygen:

8.4 - 8.9 mg/L

Nominal and measured concentrations:

- Nominal concentrations: 0 (control), 3.13, 6.25, 12.5, 25, 50 and 100 mg/L (based on a range finding study)
Test concentrations of 0, 3.13, 25 and 100 mg/L were analytically verfified at t=h0 and t=48h.
- Measured concentrations (t=0h): n.d., 3.28, 25.1 and 98.7 mg/L.
- Measured concentrations (t=48h): n.d., 3.06, 24.8 and 98.4 mg/L.

Details on test conditions:

- Test vessel: Test tubes (glass) with flat bottom (nominal volume 20 mL)
- Test medium: A synthetic fresh water was used for culture and test purposes (prepared according to ISO 10706)
- Test volume: 10mL
- Aeration: for approx. 24 h after preparation of medium until saturation with oxygen is reached.
- Loading (animals/mL): 0,5
- Number of animals/vessel: 5
- Total number of animals/conc.: 20
- Number of replicates/conc.: 4
- Number of replicates/control: 4
- Number of replicates for the measurement of pH and O2 : 1
- Number of parallels without animals: 1 (parallel 5) per test concentration and control for measurement of the pH and oxygen content at the beginning of the exposition. This parallel was thrown away after measurement. 4 per test concentration and control for concentration control analysis.
- Age of the animals at the begin of exposition: 2 - 24 h (starting with the 3rd breed of parent animals)
- Age of stock animals: 2 - 4 weeks
- Illumination: Artificial light, type warm white (OSRAM L58 W31), day:night rhythm =16 : 8 h
- Light intensity: About 1 -8 µE/(m²·s) at a wave length of 400 -750 nm
- Test parameter: Swimming ability of the test animals visually after 0, 24 and 48 h
- Feeding: None

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

47.91 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% C.L.: 36.0-68-9 mg/L

Results with reference substance (positive control):

24-h EC50 = 1.16 mg/L (Date of the last control experiment: 07 Oct 2002)

Reported statistics and error estimates:

For the statistical calculation of the EC50, the probit method (p≤0.05) was used.

Any other information on results incl. tables

Number of mobile Daphnids in the different test concentrations:

Nominal Test concentration (mg/L)	Number of mobile daphnids
0	20
3.13	20
6.25	20
12.5	18
25	15
50	9
100	5