Ethylenediamine-N,N'-di(acetic acid)

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted in compliance with GLP regulations

Justification for type of information:

Study is read across and slightly updated and presented under "type of information" as experimental study until the lead company has updated the Source RSS
Read across justification is presented in IUCLID chapter 13

Qualifier:

according to guideline

Guideline:

other: EEC Guideline XI/681/86, Draft 4: "Prolonged toxicity study with Daphnia magna: Effects on reproduction"

Principles of method if other than guideline:

For the statistical evaluation of the LOEC and NOEC Duncan's new multiple range test was used.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples for analysis were taken in the 1st, the 2nd and the 3rd week of the test. For each concentration the freshly prepared test solution (unstocked) and the corresponding 48 h or 72 h old test solution (stocked with daphnids) were analyzed.

Vehicle:

no

Details on test solutions:

At the beginning of the test and before changing the test solutions, a stock solution of the test substance was freshly prepared. A defined amount of the substance was weighed out and suspended directly in the test medium by stirring (about 10 min at 22+/-1 °C). The nominal concentrations of the stock solutions were 100 mg/L. By dilution of the stock solutions with test medium, the nominal test concentrations were prepared.

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna STRAUSS
Supplier: Institut National de Recherche Chimique Appliquée, France, 1978
Culture: The daphnids are cultured under standard conditions in the Laboratory for Experimental Ecology of BASF AG, Ludwigshafen

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Hardness:

Total hardness: 2.20 - 3.20 mmol/L

Test temperature:

19.9 - 21.7 °C

pH:

7.5-8.5

Dissolved oxygen:

Oxygen content: 8.0 - 9.6 mg/L

Nominal and measured concentrations:

Test concentrations (nominal): 100; 50.0; 25.0; 12.5; 6.25; 3.13 and 1.56 mg/L. (Dilution factor: 2)

Details on test conditions:

TEST PROCEDURE
- Semistatic procedure: Change of test solution three times a week.
- Test water: synthetic M4-medium
Alkalinity up to pH 4.3: 0.80 - 1.00 mmol/L
Molar ratio Ca:Mg: about 4 : 1
Conductivity: 550 - 650 µS/cm
- Number of animals/vessel: 1
- Number of replicates/concentration: 10
- Number of replicates/control: 10
- Age of the animals at the start of the test: 2 - 24 h
- Age of stock animals: 2 - 4 weeks
- Light: Artificial light, OSRAM L58 W31 warm white day : night-rhythm = 16 : 8 hours
- Removal of young from test beakers and counting: daily
- Check of the study and recording (mortality, hatching of young): daily
- Feeding: daily
- Measurement of temperature: Continuously in an extra vessel
- Measurement of pH and oxygen: At the start of the test and at each change of test solution in the 48
- or 72-hour-old solution in one parallel at each concentration

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Duration:

21 d

Dose descriptor:

other: LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Analytically found relative minimum and maximum concentrations of the test substance in the test solutions
at different times of the test (with and without daphnids). The values are given in percent of the nominal concentrations:


 Time   /   Stocked with   /  Minimum    /    Maximum    /
  [h]   /    daphnids      /    [%]      /      [%]      /
-----------------------------------------------------------
   0    /     no           /   80.8      /     166.7     /
 48/72  /     no           /   92.8      /     166.7     /
 48/72  /     yes          /   95.2      /     173.1     /
-----------------------------------------------------------
M4-water caused a background value of about 1 mg/L "Trilon BD". Regarding to this and to the precision of the analytical method, most concentrations found corresponded to the expected values.


Validity criteria:

In the control:
- the mortality of parent animals up to the end of the test was <= 10 %.
- the mean number of living young per parent animal that survived the  test was >= 60.
- the coefficient of variation for the mean number of living young per parent animal that survived the test was   <= 25 %.
- The NOEC of the control substance 3,4-dichloroaniline was 2.5 ug/L, the LOEC was 10 ug/L and LC0 was > 10 ug/L. 

The validity criteria were fulfilled by the test.


Control:
In the control the first young were observed at day 7. In the highest concentration tested, at which the daphnids produced young (100 mg/L), the first young were observed at day 13.

Description of key information

With high probability the test substance is chronically not harmful to aquatic invertebrates.

Key value for chemical safety assessment

Marine water invertebrates

Marine water invertebrates

Effect concentration:

21.7 mg/L

Additional information

No data on the long term toxicity to aquatic invertebrates is available for H2 ED2A. Consistent with the other ecotoxicity endpoints, the available data from H4 EDTA are read-across to fill the datagap. All ecotox and fate data from H4 EDTA, Na2H2 EDTA, Na4 EDTA, HEDTA, H2 ED2A etc have been collated in a document in which is compiled to justify the read across. This document is included in IUCLID 6, Chapter 13.

The long-term toxicity of EDTA to Daphnia magna was measured in an reproduction test according to GLP criteria [BASF AG, 1998]. In this test Na2H2 EDTA was used. In this test a NOEC of 21.7 mg/L (expressed as H4 EDTA) was observed after 21 days of exposure