Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-11-30 to 1996-04-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and application of test substrate:

Since the test substance was soluble in water, a stock solution of 15.4 mg FeEDDHMANa per mL was prepared by adding quantitatively 7.71g of test substance to 500 mL of milli-RO water. This stock solution was used for the preparation of the test concentration of 160 and 1600 mg/kg dry mass. For preparation of the lower concentrations the stock solution was diluted 10 times. An amount of the formulation and deionised water were added to artificial soil (containing 5% water).

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworm, Eisenia foetida foetida
- Source: Notox B.V. facilities
- Age at test initiation (mean and range, SD): two months
- Weight at test initiation (mean and range, SD): 300-570 mg
- Feeding: No feeding from 24 hours prior to the test and during the total test period

ACCLIMATION
- Acclimation period: 1 day prior to the test

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test temperature:

18 to 22 °C

pH:

5.7 - 6.3

Moisture:

37.5%

Details on test conditions:

TEST SYSTEM
- Test container (material, size): approximately 1 litre, all glass, covered with a plastic lid
- Amount of soil or substrate:
- No. of organisms per concentration: 40 earthworms in the control and highest concentration, 10 earthworms per concentration in between

TEST MEDIUM
Artificial soil as described in the guideline:
- 10% sphagnum peat (Jongkind B.V., Aalsmeer, The Netherlands);
- 20% kaolin clay (Silex Pottenbakkermat., 's-Hertogenbosch, The Netherlands);
- approx. 69% industrial sand M32 (Gamma, 's-Hertogenbosch, the Netherlands).
pH was adjusted to 6.0 +/- 0.5 by addition of calcium carbonate

OTHER TEST CONDITIONS
- Light intensity: 500-550 lux

Nominal and measured concentrations:

nominal: 0.16, 1.6, 16, 160 and 1600 mg/kg dry mass of artificial soil

Reference substance (positive control):

no

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

>= 1 600 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

- Mortality at end of exposure period: No test substance related mortality or other effects to the earthworms were recorded at any of the concentrations tested throughout the whole 14-day period of exposure. One worm was missing (presumably dead) in vessel D of the highest concentration at the end of the test, but up to 10% spontaneous mortality is acceptable.
- Total mass of adults at beginning of test: In the control the reduction in mean earthworm mass was 14%. There was a reduction in mean earthwormmass during the test at all concentrations, which can be explained by the absence of food during the exposure period. The reduction was not test substance related.

Reported statistics and error estimates:

Not performed

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present study the test substance did not induce significant acute mortality of Eisenia foetida foetida at or below 1600 mg/kg dry soil after 14 days of exposure.

Executive summary:

FeNa-EDDHMA was investigated according to the OECD Guideline 207 on Earthworm Acute Toxicity Test.

Earthworms of the species Eisenia foetida foetida were exposed to 5 concentrations of the test item in medium for 14 days. Milli-RO water (tap water purified by reverse osmosis) was used to dissolve the test substance, before mixing it with the artificial soil. 40 Earthworms were exposed to the blank and the highest concentration, i.e. 10 per vessel, and 10 earthworms were exposed to the concentrations in between. The concentrations of the test substance in the final study were nominally 0.16, 1.60, 16, 160 and 1600 mg/kg dry mass of artificial soil (further referred to as dry soil).

No test substance related mortality or other effects to the earthworms were recorded at any of the concentrations tested throughout the whole 14-day period of exposure. There was a reduction in mean earthworm mass during the test at all concentrations, which can be explained by the absence of food during the exposure period. The reduction was not test substance related. In the control, no earthworms died or showed other effects during the total exposure period of 14 days. The average loss of biomass of the earthworms in the controls did not exceed 20%.

Finally, under the conditions of the present study the test substance did not induce significant acute mortality of Eisenia foetida foetida at or below 1600 mg/kg dry soil after 14 days of exposure (NOEC).

Reference 2

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Remarks:

A short-term toxicity test was performed and is considered to be sufficient to cover the endpoint, since the substance will not persist in soil due to its physico-chemical properties (high water solubility, low log Kow and log Koc)..

Type of information:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Read across justification is attached in chapter 13.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

>= 1 600 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Description of key information

LC50(14d) > 1600 mg/kg soil dw (nominal) for mortality of Eisenia foetida (OECD 207, read across)

Additional information

Since no studies investigating the toxicity of Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts (CAS No. 84539-55-9) to soil macroorganisms are available, the assessment was based on a study conducted with source substance N,N'-Bis(2-hydroxy-4-methylphenyl)ethylenediamine diacetic acid, ferric-sodium complex (CAS No. 149057-66-9) in a read across approach. This is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Further justification for suitability of read across between target and source substance is given in the read across justification document attached to chapter 13. Short-term toxicity tests are considered sufficient to cover the endpoint, since the sustance is a) highly soluble in water, b) the logPow and adsorption potential is low and c) the appropriate assessment factor was used for the environmental risk assessment.

The key study was performed according to OECD guideline 207 and GLP using Eisenia foetida as test organism (Van Erp 1995). Concentrations between 0.16 and 1600 mg/kg dw soil were tested in artificial soil over an exposure time of 14 days. The test substance did not induce mortality up to the highest concentration tested. Thuis, the 14d-LC50 is determined to be > 1600 mg/kg dry soil. Based on the suitability of the read across approach, this conclusion is also considered to be true for Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts (CAS No. 84539-55-9).