potassium;2-[bis[2-[bis(carboxymethyl)amino]ethyl]amino]acetate;dicalcium

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

REPORTING FORMAT FOR THE CATEGORY APPROACH

1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See the documentation in support for the category approach.

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See the documentation in support for the category approach.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: the control, the lowest, the highest concentrations and a concentration around the expected EC50 concentration: 0, 10, 328 and 1050 mg/L
- Sampling method: All the solutions will be analysed taken directly from the starting solutions without fish.
If the analyses are not carried out on time, the solutions are kept in refrigerator or freeze. It is notified in the final report.

Vehicle:

no

Details on test solutions:

According to the sponsor, the test item is soluble in water. The dilution water was the fish test medium, a weakly saline aqueous medium.
The solutions were prepared by adding directly the test item in fish test medium

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain: not specified
- Source: Elevage de la Grande Rivière, La Fond Garel, 69490 ST FORGEUX (Approval number : A69-200-1301). Batch Number: 150317
- Age at study initiation (mean and range, SD): not specified
- Length at study initiation (length definition, mean, range and SD): 25 to 30 mm
- Weight at study initiation (mean and range, SD): not specified

ACCLIMATION
- Acclimation period:
Every batch of fish received in the laboratory were held in the dilution water for a minimum time period of 12 days before testing.
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: not specified
- Feeding frequency during acclimation: not specified
- Health during acclimation (any mortality observed): free from any apparent malformations and diseases.

FEEDING DURING TEST
no

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

22.8-23.4°C

pH:

6.6-7.9

Dissolved oxygen:

90-98%

Nominal and measured concentrations:

nominal: 0, 10, 32, 102, 328, 1050
measured: see table below

Details on test conditions:

TEST SYSTEM
- Test vessel: aquarium
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 15cm * 15cm * 20 cm containing 2.5L of the test solution
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 8
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: 1.0 g/L

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light / 8 hours darkness
- Light intensity: not specified

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality

TEST CONCENTRATIONS
0, 10, 32, 102, 328, 1050
- Range finding stud: yes
- Test concentrations:
range finding study: 0, 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 050 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

The toxic response obtained on the reference item K2Cr2O7 for the Fish batch number 150317 gives a LC50-24h of 190.6 mg/L [169.9 – 213.7], in accordance with historical data obtained by our laboratory.

Reported statistics and error estimates:

See table below.

Sublethal observations / clinical signs:

The statistical treatment of the data permitted to giveLC₅₀values at different observation times.

 

LC₅₀values at different observation times (Value expressed in nominal test item concentration) are presented hereafter.

 

Observation time	24h	48h	72h	96h
LC50in mg/L	>1050 mg/L	>1050 mg/L	>1050 mg/L	>1050 mg/L

  Validity criteria conformity

Criteria	Validity for OECD 203	Validity for the test
Control mortality	≤ 1 fish	Ok (0)
Conditions	Constant	Ok (22.8 to 23.4 °C)
Dissolved oxygen concentration	> 60%	Ok (90%)
Concentrations maintaining	± 20%	YES (2.3 to 6.3%)

NA: Not applicable (see § 11.4.5)

 

All the validity criteria were successful.

Validity criteria fulfilled:

yes

Conclusions:

All the validity criteria were successful.

The results obtained for the test item « REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA» on the toxicological endpoint “mortality” give an LC50-96h higher than 1050 mg/L (highest tested concentration), values expressed in nominal test item concentration.

Executive summary:

This study was carried out in accordance with the study plan no.17/1107F/d dated October 23, 2017.

There was no deviation and no amendment during this study.

 

The aim of this study was to assess the effects of the test item «REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA» on the fishDanio rerio, according to the OECD 203 guideline, in static conditions.

 

According to the sponsor, chemical analyses of the test item in the test solutions were performed during the test.

 

Validity criteria conformity:

Criteria	Validity for OECD 203	Validity for the test
Control mortality	≤ 1 fish	Ok (0)
Conditions	Constant	Ok (22.8 to 23.4 °C)
Dissolved oxygen concentration	> 60%	Ok (90%)
Concentrations maintaining	± 20%	YES (2.3 to 6.3%)

 

All the validity criteria were successful.

Fish lethality

Nominal test item concentrations (mg/L)	Number of fish exposed at the start	Cumulative number of dead fish at each observation time (%)
		24h	48h	72h	96h
Control	8	0 (0%)	0 (0%)	0 (0%)	0 (0%)
10	8	0 (0%)	0 (0%)	0 (0%)	0 (0%)
32	8	0 (0%)	0 (0%)	0 (0%)	0 (0%)
102	8	0 (0%)	0 (0%)	0 (0%)	0 (0%)
328	8	0 (0%)	0 (0%)	0 (0%)	0 (0%)
1050	8	0 (0%)	0 (0%)	0 (0%)	0 (0%)

 

 

LC₅₀values at different observation times(Value expressed in nominal test item concentration) are presented hereafter.

 

Observation time	24h	48h	72h	96h
LC50in mg/L	> 1050 mg/L	> 1050 mg/L	> 1050 mg/L	> 1050 mg/L

 

The results obtained for the test item « REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA» on the toxicological endpoint “mortality” give an LC₅₀-96h higher than 1050 mg/L(highest tested concentration), values expressed in nominal test item concentration.

Description of key information

Information on the short-term toxicity to fish is available for one category member. The result is in line with the expectations i.e. that the aquatic toxicity is the result of the free (metal) ion that is complexed and that this ion is much less bioavailable and thus less toxic to aquatic life when complexed with the chelating agents.

The 96h LC50 for fish (OECD 203) was determined to exceed 1050 mg/L for the metal chelate with zinc.

Considering that the aquatic toxicity is determined by the metal ion and that K and Ca are orders of magnitude less toxic than Zn, the substance is not considered toxic to fish.