Pyrazino[2,1-a]isochinolin-4-on, 4H-, 1,2,3,6,7,11b-hexahydr o-, Diphosphat

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:

Nov 13, 2002 - Feb 25, 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to OECD TG 202.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69 and OECD No. 202

Deviations:

no

Principles of method if other than guideline:

none

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

other: solid

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

after 0, 24 and 48 hours

Test solutions

Vehicle:

no

Details on test solutions:

Reconstituted water according to ELENDT (1990):
Macro nutrients (mg/L):
CaCI2 x 7 H20 293.80
MgSO4 x 7 H20 123.30
NaHCO3 64.80
KCI 5.80
Na2SiO3 x 9H20 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 2H20 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 an 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

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (Strauss)
- Strain: Strauss
- Source: in house
- Age at study initiation (mean and range, SD): not older than 24 hours
- Feeding during test: yes
- Food type: suspension of fresh water algae
- Amount: sufficient
- Frequency: once a week

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

14 ° dH (about 250 mg/L CaCO3)

Test temperature:

21-22 °C

pH:

7.2- 7.8

Dissolved oxygen:

90 %

Nominal and measured concentrations:

100 mg/L

Details on test conditions:

-- Preparation
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the test material was solved in the vehicle, reconstituted water

-- Administration
At the start of the experimental phase, 5 Daphnia magna were placed into 10 ml of reconstituted water (4 vessels/control group) or test medium (4 vessels/ test material group). The Daphnia magna were not fed, and the control medium and test medium were not aerated during the test.
The test vessels were labeled to assure unique identification.

-- Dose levels
A single test material concentration of 0.1 g/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 (O2) were measured in the control and all test material 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 with an electronic thermometer containing a maximum and minimum memory display.

-- Archive statement
All raw data, specimens and the final report are stored in the archives of the test facility.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

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.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the given experimental conditions, the test material showed no aquatic toxicity. The 48 hours NOEC to Daphnia magna is > 100 mg/L.

Executive summary:

Purpose

The purpose of this assay was to identify the aquatic toxicity potential of the test material in Daphnia magna to provide a rational basis for hazard estimation for the test item in aquatic environments.

Study design

For this purpose, juvenile Daphnia magna were exposed to an aqueous test material preparation over 48 hours, under defined conditions. The GLP study was performed as a limit test according to OECD TG 202.

Results

The follwing results have been obtained:

   

Nominal concentration Immobilization immobilized / exposed
[g/L]	24 hours	48 hours
0.0	0/20	0/20
0.1	0/20	0/20

Daphnia magna exposed to an aqueous preparation of the nominal concentration of 100 mg per L of test item were not affected.

For the test material the following EC50 values for Daphnia magna were determined:

24 h EC50 > 0,1 g/L (nominal > 100 mg/L)

48 h EC50 > 0,1 g/L (nominal > 100 mg/L)

NOEC > 0.1 g/L (nominal)

LOEC > 0.1 g/L (nominal)

Conclusions

Under the given experimental conditions, the test material showed no aquatic toxicity. The 48 hours NOEC to Daphnia magna is > 100 mg/L.