Amorphophallus campanulatus dry purified extract

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Test article name : Amorphophallus campanulatus dry purified extract
Batch code : 29895/M1
Chemical class : Botanical extract
Preparation date : April, 2009
Expiry date : April, 2011
Physical form at 20°C : Powder
Colour : Pale brown
Storage conditions : The product will be stored at room temperature, in well ventilated room, in its own original container
Safety precautions : Routinely hygienic procedures

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

140 - 250 mg/L as CaCO3

Test temperature:

The incubation temperature was continuously monitored during the course of the study by the means of a data logger. The measured values ranged between 20.7 and 22.3 °C during the test period.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

IC50

Effect conc.:

> 100 mg/L

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Any other information on results incl. tables

A limit test was performed in accordance with the EU Commission Directive 92/69 to evaluate the effect of the test itemAmorphophallus campanulatusdry purified extract onDaphnia magna.

The daphnids were observed for immobility after 24 and 48 hours of exposure. The observed immobilization in the test concentrations and in the control is reported in Table 2.

Table 2 Lethal effect ofAmorphophallus campanulatusdry purified extract toDaphnia magna

Nominal test item concentration [mg/L]	No. of Daphnia tested	No. of immobilized Daphnia		% of immobilized Daphnia
		24 h	48 h	24 h	48 h
0 (control)	20	0	0	0	0
100.0	20	0	0	0	0

In the control 0% immobilization was observed during the test period at each observation time (Table 2). This value complies with the validity criteria of the test, according to the mentioned guidelines.

The results were analyzed for significant differences from control with Fisher’s Exact test (α = 0.05) by the mean of CETIS elaboration software v1.026D.

The NOEC (highest concentration tested without toxic effects after the exposure period) was determined to be equal to the nominal tested concentration, 100 mg/L, at both the observation times.

Given the nature of limit test, the LOEC and the 48-h IC₅₀could not be determined, but, according to the results, were assessed to be greater than the nominal concentration tested (i.e., IC₅₀> 100 mg/L).

No remarkable observations were made concerning the appearance of the test medium. The test medium was a clear solution throughout the whole test duration.

The incubation temperature was in the range 20.7 – 22.3 °C (Figure 1), with a mean value of 21.3 °C and a standard deviation of 0.4 °C. These values slightly exceeded the recommended range (20.0 ± 2.0 °C, however this excess did not affect the results of the study, as showed by the immobilization data in the control.

Fig 1               Trend of temperature during the test period

During the test period, the dissolved oxygen concentrations in the test medium and in the control were always greater than 6.0 mg/L (Table 3). Immediately after preparation, the pH in test solution was 7.55 for the test item and 7.45 for the control and the pH did not vary more than 1 unit during the test, as required by the mentioned guidelines (Table 3).

Table 3 Dissolved oxygen concentrations and pH values in the test media at 0 and after 48 hours from test start of the test period

		Nominal test item concentration (mg/L)
		0 (control)	100.0
Dissolved oxygen (mg/L)	0 h	6.58	6.50
	48 h	6.54	6.30
pH	0 h	7.45	7.55
	48 h	7.39	7.48

Applicant's summary and conclusion

Conclusions:

The test item Amorphophallus campanulatus dry purified extract caused no adverse effect to Daphnia magna after 48-hours exposure at a nominal product concentration of 100 mg/L under static conditions.

The NOEC, LOEC and IC50 values after 24 and 48 h, calculated based on the nominal concentrations were as follows:

NOEC 100 mg/L
LOEC > 100 mg/L
IC50 > 100 mg/L.