Trimetazidine

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

7 Sept. 2004 to 10 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 201 (Alga, Growth Inhibition 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:

To prepare the stock solution, the test item was dissolved or dispersed directly in LC reconstituted water. The obtained preparation was agitated mechanically for up to 24 hours in an attempt to completely dissolve or disperse the test item and homogenize the solution.
Water: reconstituted (LC). Prepared using deionized water with a conductivity less than 10 PS/cm. The final solution after autoclaving has a pH of 7.5 ± 0.3.
Test solutions was prepared by further dilution of the stock solution with water 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):

Scenedesmus sp.

Details on test organisms:

Species: Scenedesmus subspicatus.
Strain No.: CCAP 276/20.
Reason for this choice: rapidly growing unicellular species commonly used in Europe for aquatic toxicity testing and recommended in OECD and EEC guidelines.
Cultured at: CIT.
Origin: Culture Collection of Algae and Protozoa, Institute of Freshwater Ecology, Far Sawrey, Ambleside, Cumbria, LA22 OLP, UK.
Culture method: the algae are cultured under sterile conditions and maintained at exponential growth rate by adding weekly aliquots of algal culture to fresh reconstituted water samples.

Study design

Test type:

static

Water media type:

freshwater

Total exposure duration:

72 h

Test conditions

Hardness:

Measured but not specified in the report.

Test temperature:

between 24.0°C and 25.0°C.

pH:

In the control solution : pH between 7.39 to 8.40
In the test solution with adjusted pH : between 9.62 to 8.07
In the test solution without adjustement : between 8.88 to 7.90

Dissolved oxygen:

Not specified

Salinity:

Not specified

Conductivity:

less than 10 PS/cm

Nominal and measured concentrations:

Nominal concentrations : 0 ; 1 ; 10 & 100 mg/L

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 10 - < 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Remarks:

With or without pH adjustment

Results with reference substance (positive control):

Not specified

Any other information on results incl. tables

Table 1 : pH & temperature

Nominal concentration (mg/L)	pHat T0 hour	pH at T72 hours
0	7.39	8.40
100*	9.62	8.07
100**	8.88	7.90

* solution with no adjustment of pH

** solution with adjusted pH

Temperature measured in the dilution water between at T0 and T2 hours: 24.3 ° C

Temperature recorded in a dilution water beacker placed under the conditions of the study: minimum 24.0°C / maximum 25.0°C

 

Table 2: T72 hours - number of cells and calculation of the specific growth rate for each concentration

Nominal concentration (mg/L)	Replicat	Total number of cells at T72 hours (104/mL)	Ln number of cells	Average Ln number of cells	Specific growth rate	Growth rate inhibition
0	1 2 3	85.0 89.5 106.0	13.65 13.70 13.87	13.74	0.06
1*	1 2 3	118.0 161.0 152.0	13.98 14.29 14.23	14.17	0.07	-9.38
10*	1 2 3	118.0 131.0 107.0	13.98 14.09 13.88	13.98	0.07	-5.28
100*	1 2 3	2.2 1.7 3.9	10.00 9.74 10.57	10.10	0.01	80.29
100*	1 2 3	7.0 9.1 7.6	11.16 1 1.42 11.24	11.27	0.03	54.54

Ln number of cells at T0 hour (10 000 cells) = 9,21

* solution with no adjustment of pH

** solution with adjusted pH

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 0-72h EC50b was estimated to be between 10 and 100 mg/L with or without pH adjustment.

Executive summary:

A growth inhibition test on algae according to OECD 201 was performed.

The highest concentration no observed effect on algae growth (NOEC) at T72h was 10 mg/L, based on growth rate and biomass (p = 0.05).

At the concentration of 100 mg/L, inhibition of algae growth resulted from both a toxic effect of the test item (not pH-related) and its basic potential.

The 0-72h EC50r was estimated to be between 10 and 100 mg / L without pH adjustment and close to 100 mg/L with pH adjustment.

The 0-72h EC50b was estimated to be between 10 and 100 mg / L with or without pH adjustment.