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 fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

12-02-1997 till 21-03-1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

The underlying hypothesis for the read-across is that chelates have the same mode of action based on their ability to chelate, remove or add metal cations to body causing perturbation of body’s micronutrients balance.
The source substance is a chelating agent in a target substance. The only difference between the target and the main source substance is presence of calcium (Ca) cation instead two Na+ 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

not specified

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

The concentrations of the C-containing components of the test medium were confirmed by TOC determination.

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Origin: Bio International B.V. (Netherlands)
Date of Birth : 13-03-1996
Date supplied : 13-08-1996
Body length: 2.5 - 3.5 cm
Mortality while kept < 2%
Medical pretreatment: none
Keeping water: synthetic freshwater according to the above guideline

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

no data

Test temperature:

22 ±2° C

pH:

7.5 - 7.8

Dissolved oxygen:

7.6 - 8.5 ml/L 02

Salinity:

not applicable

Nominal and measured concentrations:

nominal: 100 mg/l

Details on test conditions:

In the main test, defined concentrations of the test substance will lead to a certain percentage proportion of dead fish at the end of the study period. The LC O and the LC 100 are determined directly from the study, while the LC 50 is calculated or read from the dose­ response curve. The study lasts for 96 hours. During the test a temperature range of 20 - 24°C is to be maintained in the test vessels, with a maximum temperature fluctuation of+/- 1°C in each individual test. Mortality of fish is recorded every 24 hours. pH and oxygen values are measured at the beginning of the test and every 24 hours thereafter.

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 82.6 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: The above LC O refers to the arithmetic mean of TOC determinations, multiplied by a factor 3.5 (] mg/I TOC equals to 3.5 mg/I of the test substance)

Details on results:

Control and test fish exhibited normal swimming behaviour throughout the test period.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Mortality: no observed

Validity criteria fulfilled:

yes

Conclusions:

The LC O (acute fish toxicity) of IDS, sodium salt for the zebra fish (Brachydanio rerio) is > 82.6 mg/I.

Executive summary:

This study was designed to assess the acute toxic effects (mortality)  of

IDS, sodium salton a freshwater fish species (Brachydanio rerio) under static test conditions.

 

The study was conducted according to the Council Directive 67/548/EEC; Official Journal of the EC L 383 Part A/163(1992).

This test method is in most parts identical with OECD Guideline  203.

 

The method assesses the acute toxic effects (mortality) of various concentrations of a test substance on a fresh water fish species.

 

The purpose of this method is to determine that concentration which causes a 50% mortality rate (=LC 50) or, if conducted as a limit test, to determine the acute toxic effects at a maximum test concentration of 100 mg/I or at the limit ofwater solubility,  respectively.

The LC O (acute fish toxicity)  of IDS, sodium salt for the zebra fish (Brachydanio rerio) is > 82.6 mg/I.

Description of key information

The LCO (acute fish toxicity)  of IDHA, sodium salt (other name IDS, sodium salt) for the zebra fish (Brachydanio rerio) is >= 82.6 mg/I.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

82.6 mg/L