Trimetazidine

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

31 Aug. 2004 to 2 Sept. 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trimetazidine

EC Number:

225-690-2

EC Name:

Trimetazidine

Cas Number:

5011-34-7

Molecular formula:

C14H22N2O3

IUPAC Name:

1-[(2,3,4-trimethoxyphenyl)methyl]piperazine

Test material form:

liquid

Details on test material:

No details are provided in the study report

Specific details on test material used for the study:

No analytical data are provided on the test material in the study report. Batch N°538271/0124

Sampling and analysis

Analytical monitoring:

not specified

Test solutions

Vehicle:

no

Details on test solutions:

Preparation of the stock solution:
To prepare the stock solution, the test item was dissolved or dispersed directly in M4 reconstituted water. The obtained preparation was agitated mechanically for up to 24 hours in an attempt to completely dissolve or disperse the test item.
Water: reconstituted (M4). The pH of this solution is 8.0 ± 0.5 and the sum of Ca and Mg ions in the solution is 2.5 mmol/L with a molar ratio of Ca to Mg ions of approximately 4:1, and of Na to K of 10:1.

Preparation of the test solutions:
Test solutions was prepared by further dilution of the stock solution with M4 or directly from the test item. A solution containing a maximum of 100 mg/L of the test item plus two other range-finding concentrations was prepared. Test vessels was filled directly from the test solution containers immediately after preparation.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species, clone: Daphnia magna STRAUS, clone 5.
Reason for this choice: most sensitive clone of the species recommended in OECD and EEC guidelines. Breeder: CIT.
Origin: Centre Technique du Bois et de l'Ameublement, 75012 Paris, France.
Age: between 6 and 24 hours.
Acclimation: none.
Allocation of the animals: animals was selected without preference and randomly assigned to test vessels.
Number of animals: 20 animals per concentration divided into four replicate groups of five animals.

Study design

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Test conditions

Hardness:

Betwen 289mg/L and 306mg/L in the control flask.

Test temperature:

measured during the test but not specified in the report.

pH:

Between 8.32 and 8.95

Dissolved oxygen:

Between 8.8mg/L and 8.9mg/L.

Salinity:

Not specified (freshwaterused).

Conductivity:

Not specified.

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

The EC50 at 48hours is estimated close to 100mg/L.

Any other information on results incl. tables

Table 1: Physicochemicalparameters

Control
Temps	Hardness (mg/L)	Oxygene level (%)	Oxygene level (mg/L)	pH
T 0 hour	289	98	8.8	8.32
T 48 hours	306	99	8,9	8,33
Highest concentration tested
Temps	Oxygene level (%)	Oxygene level (mg/L)	pH	Nominal concentration (mg/L)
T 0 hour	99	8.9	8.95	100
T 48 hours	98	8.8	8.42	100

 

Temperature measured in the dilution water between T0 hour and T2 hours: 19.8°C.

Temperature recorded in a beaker of dilution water placed under the conditions of the study: minimum 19.4°C / maximum 19.8°C.

Table 2: Summary of mortality

Immobilisation (n daphnies on 5) at each nominal concentration (mg/L)
	0				1				10				100
	Replicat				Replicat				Replicat				Replicat
	1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4
T0 hour	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
T24 hours	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
T 48hours	0	0	0	0	0	0	0	0	0	0	0	0	3	2	0	4

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The highest concentration without immobilization at T48h was 10 mg/L.
The lowest concentration with 100% immobilization at T48h was >100 mg/L.
The 24h EC50 was >100 mg / L.
The EC50 at 48h was estimated to be close to 100 mg / L.

Executive summary:

The objective of this study is to assess the acute toxicity of TMZ BASE, in Daphnia magna STRAUS - clone 5, in a 48-hour static test, according to the 202 OECD guideline.

The test was carried out by subjecting 20 animals to a maximum concentration level of 100 mg/L and further groups of 20 animals to two other test solutions, i.e. 1 and 10 mg/L, over a 48-hour period. The control also contained 20 animals.

The highest concentration without immobilization at T48h was 10 mg/L.

The lowest concentration with 100% immobilization at T48h was >100 mg/L.

The 24h EC50 was >100 mg / L.

The EC50 at 48h was estimated to be close to 100 mg / L.