Reaction mass of iron chelate of sodium salt N-[1,2 dicarboxyethyl] D,L aspartic acid and sodium chloride

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June, 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented guideline study in compliance with GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

exceeded size of fish and exceeded maximum fish load per liter which was 1.28 g/L insted of 1.0 g/L. Trout's sensitivity was checked and had no influence to final results. There no possibility to obtain fish of smaller size.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L (limit test)
- Sampling method:
5 ml of acetonitrile was added to 5 ml of water sample (control sample, sample with test amterial or fortificated with standar 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 acetonitrile.

Vehicle:

yes

Details on test solutions:

Natural de-chlorinated tap water was used as a vehicle.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Rainbow trout (Oncorhynchus mykiss) was obtained from Salmonidae Fish Farm in Zawoja, Małopolskie Voivodship of average lenght 6.93 cm =/- 0.77 (min. lenght 5.5 cm, max lenght 8.1 cm) and average weight 3.19 g (n= 30).
Trout's fry sensitivity was checked in the test with reference substance (K2Cr2O7) was similar to previous parties of this fish species. Fish were healthy and in good physiological condition.

ADAPTATION TO TEST CONDITION
After delivery, the fish were adapted one week before using in the experiment. Adaptation was performed in air-conditioned room. The tank had a volume of 2.5 m3 with a closed system with contious water circulation. Tap water was filtred continously (through layers of sponge, active carbon and volcanic lava), aerated with fresh air and disinfected by UV lamp. During adaptation fish were fed with standard granulated fish fodd in amount of 2% of their mean body weight per day (standard salmonid fry food, Aller Aqua 493 2-GR Denmark). The feeding was terminated 24 h before start of the test. Fish used in experiment were healthy and free from external parasites and as well visible deformation (veterinary control). The mortality in the fish population during adaptation perion was below 5%.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

The post exposure observation was not performed.

Hardness:

103.5 mg CaCO3/L

Test temperature:

13.7 - 14.3 oC

pH:

7.74

Dissolved oxygen:

60%

Salinity:

not applicable

Nominal and measured concentrations:

100 mg/L

Details on test conditions:

Experiment was carried out in 10 L aquariums in static manner i.e. test solutions weren't changed but they were mixed during aeration. Natural de-chlorinated tap water were used. The test duration was 96h. The test was run under natural photoperiod but in addition fluorescent light source was used in daily schedule: 16 h of light - 8 h of darknes. The fish were not fed during test period. Seven fish were used per concentration and the same in control.
Observations of intoxication (loss of balance, swimming behavior, respiratory function and pigmentation) and mortality were made after 3h and 6h of the test set up nd then every 24h. Fish are considered dead if there is no reaction to external stimuli.

Reference substance (positive control):

yes

Remarks:

K2Cr2O7

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

During the test no moratlity was observed not any effects of intoxication in tested fish population.

Validity criteria fulfilled:

yes

Remarks:

mortality in control 0%, concentration of dissolved oxygen 88.3 - 136.1 % of oxygen saturation

Conclusions:

The LC50/96h value is above 100 mg/L, LC0 value is equal or above 100 mg/L, and LC100 value is above 100 mg/L.

Executive summary:

Evaluation of acute toxicity of Fe(III)IDHA for rainbow trout was performed according to the OECD Guideline 203 , method C.1. and Principles of Good Laboratory Practice (GLP, OECD 1997).

The test material was used in only one concentration (limit test) - 100 mg/L in static manner. Contents and stability of test material in test concentration were determined in chemical analysis (HPLC) at t0 and t96. The test duration was 96h.

Observation of intoxication (loss of balance, swimming behavior, respiratory function and pigmentation) and mortality were made after three and six hours of the test set up and then every 24 hours. Because of no mortality was observed in tested fish popultion the LC50/96h value is above 100 mg/L, LC0 value is equal or abovve 100 mg/L, and LC100 value is above 100 mg/L.

Description of key information

The LC50/96h value is above 100 mg/L, LC0 value is equal or above 100 mg/L, and LC100

value is above 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The test substance Fe(III)IDHA was used in only one concentration (limit test) - 100 mg/L in static manner. Contents and stability of test material in test concentration were determined in chemical analysis (HPLC) at t0 and t96. The test duration was 96h.

Observation of intoxication (loss of balance, swimming behavior, respiratory function and pigmentation) and mortality were made after three and six hours of the test set up and then every 24 hours. Because of no mortality was observed in tested fish popultion the LC50/96h value is above 100 mg/L, LC0 value is equal or abovve 100 mg/L, and LC100 value is above 100 mg/L.