Reaction mass of disodium [2,2'-(imino-κN)dibutanedioato-κ2O1,O4(4-)]calcium(2-), sodium chloride and aspartic acid disodium salt

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

June 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented guideline study in compliance with GLP

Justification for type of information:

A substantial body of evidence exists that the toxicity profiles of chelates depends mainly on metal ion, its affinity to this metal, and their ability to supply or to sequester it from the body/environment. The source substance has the same chelating agent as in a target substance (CaNa2IDHA). The only difference between the target and the source substance is presence of calcium (Ca) cation instead Fe3+ cations. As calcium is an essential macro element required by all forms of life, is considered not to influence the toxicological activity.

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

5 ml of acetonitrile was added to 5 ml of water sample (control sample, sample contaminated with test material or fortified with standard solution) in Erlenmeyer flask. Contents of the flask was mixed throughly and applied to the chromatographic column in volume of 20 µL. Solutions of Fe(III)IDHA in concentration below 2 mg/L were injected to the chromatographic column without dissolving in acetone.

Vehicle:

no

Details on test solutions:

In the study test material was used in one concentration (limit test) - 100 mg/L. Concentration of test material was prepared by weighing of 10 mg of test material, precise mixing in 100 ml of Elendt water used in test, and then introducing to the test system.

Test organisms (species):

Daphnia magna

Details on test organisms:

Animals Daphnia manga used in experiments were taken from own laboratory culture of Institute of Organic industry, Branch Pszczyna. In the experiments animals in good physiological condition (checked by test with refrence substance - potassium dichromate) up to 24 hours old were used.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

not reported

Hardness:

not reported

Test temperature:

22-23oC

pH:

control: 7.6- 7.77
tested solution: 8.64 - 8.51

Dissolved oxygen:

control: 8.79-8.67
tested solution: 8.64-8.51

Salinity:

not applicable

Nominal and measured concentrations:

nominal concentration: 100mg/L
measured concentration:
t0= 101.06 mg/L
t48h = 94.4 mg/L

Details on test conditions:

The test environmental and the dilution medium used for preparing the test material solution was standarized elendt water M7, the same like used in culture. The test was run in plastic test containers of 100 mL capacity. Before test start Elend water was aerated for 30 min. Test concentrations as well as control was set up in four replicates. The volume of the test material solution in every replicate was 25 mL. Five individuals of Daphnia manga were used per each replicate (i.e. 20 animals per concentration). Therefore there was 5 mL of test solution per each animal (acc. to OECD gudeline should be at least 2 mmL). The test was run for 48 hours in natural photopheriod. The test was run in static manner. Animals were not fed during the test and the temperature was maintained in range 22-23oC. At the begining of the test and after 48 h pH values and content of dissolved oxygen were measured, the same measurements were performed for fresh solutions (pH-Oxi-metr inoLAB Level 3, WTW Germany).

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

>= 100 mg/L

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Details on results:

All validity criteria were met:
- mortality and immobilization of tested animals in control was 0%
- concentration of dissolved oxygen was 8.67 mg/L after 48h

Results with reference substance (positive control):

Resultsts for K2Cr2O7:
EC50(24h) > 3.2 mg/L
EC50(48h) = 1.13 mg/L (0.93-1.37 mg/L)

Validity criteria fulfilled:

yes

Conclusions:

Median concentration causing 50% immobilization of Dapnia manga population (EC50) after 48h was above 100 mg/L, EC0 after 48h is above or equal 100 mh/L, and EC100 after 48H is above 100 mg/L.

Executive summary:

The toxicity assessment of Fe(III)IDHA was performed according to OECD Guideline 202 and test method C.2 and in compiance with GLP (OECD, 1997). The aim of the study was evaluation of acute toxicity to Daphnia manga exposed to a range of concentrations of the test material (determination of EC50, EC0 and EC100 in mg/L after 24h and 48h exposure).

The test material was used in only one concentration (limit test) - 100 mg/L. Because of no mortality was observed in tested Daphnia population the EC50/48h value is above 100 mg/L, EC0 value is equel or above 100 mg/L, and EC100 value is above 100 mg/L.

Description of key information

The toxicity assessment of FeNaIDHA was performed according to OECD Guideline 202 and test method C.2 and in compiance with GLP (OECD, 1997). The aim of the study was evaluation of acute toxicity to Daphnia manga exposed to a range of concentrations of the test material (determination of EC50, EC0 and EC100 in mg/L after 24h and 48h exposure).

The test material was used in only one concentration (limit test) - 100 mg/L. Because of no mortality was observed in tested Daphnia population the EC50/48h value is above 100 mg/L, EC0 value is equel or above 100 mg/L, and EC100 value is above 100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L