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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-04-27 to 2010-06-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Name of test material (as cited in study report): Acetic acid,oxo-,sodium salt (FeNaEDDHA)
-Synonym: Acetic acid,oxo-,sodium salt, reaction products with ethylenediamine and phenol,iron sodium salts
- Physical state: Solid/ red, dark
- Analytical purity: 100 % (UVCB)
- Lot/batch No.: 09226BR8
- Expiration date of the lot/batch: 07 Mar 2012
- Storage condition of test material: At ambient temperature under exclusion of light

Analytical monitoring:

yes

Details on sampling:

Samples for analytical determination of the concentration were taken within 30 minutes before insertion of the test organisms (start of exposure) and at the end of the exposure after approx. 96 hours. Water samples were taken from the middle of the test vessel using a glass pipette and were transported to the analytical laboratory in glass ampoules.
The transport to the Analytical Laboratory was done on the day of sampling.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The test substance (1.20168 g) was weighed into a beaker. The defined volume of test water (10 L) was filled into the test vessel and an aliquot was removed and mixed with the test substance in a beaker using an ultra turrax high shear mixer. The mixture was then poured into the test vessel and theentire volume of test solution was homogenized again with an ultra turrax.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: ZF BioLabs, Ronda da Valdecarrizo 41°B. 28760, Tres Cantos (Madrid), Spain
- Age at study initiation (mean and range, SD): Approx. 12 months
- Length at study initiation: 3.3 cm (3.2 – 3.4 cm)
- Weight at study initiation: 0.35 g (0.25 – 0.48 g)
- Feeding during test: ad libitum, additionally generally on workdays live brine shrimp (artemia nauplii).
- Food type: Commercial fish diet “Tetramin“,

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

Approx. 1 mmol/L = 100 mg/L CaCO3

Test temperature:

24 degree C

pH:

7.5 - 8.5

Dissolved oxygen:

> 80 % saturation

Nominal and measured concentrations:

Nominal concentration based on test substance mass without a correction for composition: 120 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Stainless steel aquaria (29 cm long, 21 cm wide, 22 cm high) partially covered with a black cover
- Volume of water: 10 L
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- Aeration: Slight

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Non chlorinated charcoal filtered tap water (Frankenthal, Germany) mixed with deionized water, aerated
- Conductivity: Approx. 250 uS/cm (at 25 degree C)

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: The experiment was performed under reduced light intensity, since the test substance is potentially light sensitive.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The fish were observed for mortality and toxic signs (changes appearance and abnormal behaviour in comparison to the control group) within 1 hour after start of exposure and 6, 24, 48, 72 and 96 hours after start of exposure. Fish were considered dead if there was no visible movement and no reaction after touching. Dead fish were removed from the test vessels.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: None
- Mortality of control: No
- Other adverse effects control: None

Reported statistics and error estimates:

Since the study is designed as a limit test, no statistical analysis was performed.

Sublethal observations / clinical signs:

Cumulative mortality (number of dead animals):

Nominal concentration [mg/L]	Number of fish	1 hour	6 hours	24 hours	48 hours	72 hours	96 hours
0	7	0	0	0	0	0	0
120	7	0	0	0	0	0	0

Toxic signs:

Nominal concentration [mg/L]	Number of fish	1 hour	6 hours	24 hours	48 hours	72 hours	96 hours
0	10	n	n	n	n	n	n
120	10	n	n	n	n	n	n

Explanation of abbreviations

n = no toxic signs observed                   

The following effect concentrations (mg/L) were obtained based on nominal concentrations:

	Observation time (hours after start of exposure)
	1 hour	6 hours	24 hours	48 hours	72 hours	96 hours
LC0	>120	>120	>120	>120	>120	>120
LC50 (95% confidence limits)	> 120 -	> 120 -	> 120 -	> 120 -	> 120 -	> 120 -
LC100	> 120	> 120	> 120	> 120	> 120	> 120
NOEC	>120	>120	>120	>120	>120	>120

- insufficient data for calculation

Validity criteria fulfilled:

yes

Conclusions:

In conclusion the 96 hour LC50 value for FeNaEDDHA with the zebrafish (Danio rerio) was > 120 mg/L based on the nominal concentration of the testsubstance and > 122 mg/L based on the mean of analytically determined concentrations. The 96 hour NOEC was determined to be greater than or equal to 120 mg/L.

Executive summary:

The acute toxic effects (lethality) of FeNaEDDHA to zebrafish over a 96 hour static exposure period were determined according to the principles of OECD-Guideline 203 and EU method C.1 (limit test). The test substance was tested at 120 mg/L, which was analytically confirmed.

The 96 hour LC50 value for FeNaEDDHA with the zebrafish (Danio rerio) was greater than 120 mg/L based on the nominal concentration of the test substance and greater than 122 mg/L based on the mean of analytically detemined concentrations. The 96 hour NOEC was determined to be greater than or equal to 120 mg/L. Since the analytically determined concentrations of the test substance in the test solutions were within +/- 20% of the nominal concentrations, the effect concentration is expressed relative to the nominal concentration.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1977

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

In accordance with the method reported by Bathe et al (1974) which is a modification of the procedure proposed by the United States Department of the Interior Fish and Wildlife Service, reported in "Procedure for Evaluation of Acute Toxicity of Pesticides to Fish and Wildlife".

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): technical CGA 65047, identical to FeNaEDDHA
- Lot/batch No.: P. 2/3/4
- Analytical purity: 100 % (UVCB)

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
Various concentrations of CGA 65047 were prepared by adding the test material dissolved in aqua dest. (stock solution). (solubility of active ingr. in water: well miscible) at the appropriate amount ensuring that the total volume in each vessel remained the same.

Test organisms (species):

other: Salmo gairdneri, Cyprinus carpio, Ictalurus nebulosus, Lepomis macrochirus

Details on test organisms:

TEST ORGANISM
1. Rainbow trout (Salmo gairdneri), supplied by "Mändli", Liestal, Switzerland, fish breeding station.
Average Weight: 6.8 g
Average Length: 82 mm

2. Carp (Cyprinus carpio), supplied by "Riegger", Ettenheim, W.Germany, fish breeding station.
Average Weight: 7.5 g
Average Length: 80 mm

3. Catfish (Ictalurus nebulosus), supplied by "Weber", Wohlen Switzerland.
Average Weight: 3.9 g
Average Length: 65 mm

4. Bluegill (Lepomis macrochirus), supplied by "Exotarium Stubenvoll", Allschwil, Switzerland.
Average Weight: 4.3 g
Average Length: 60 mm

Prior to testing, the fish were adapted to laboratory conditions for a minimum of 10 days. They were kept in 250 lit. glass tanks containing normal drinking water which was aerated and filtered continuously through a filter bed of activated charcoal. The fish were fed daily. Prior to testing the food was withdrawn for 3 days.

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

14 +/- 2 degree C (trout, bluegill)
22 +/- 2 degree C (carp, catfish)

Nominal and measured concentrations:

rainbow trout: 28 mg/kg, 100 mg/L
carp: 49 mg/kg, 100 mg/L
catfish: 49 mg/kg, 100 mg/L
bluegill: 49 mg/kg, 100 mg/L

Details on test conditions:

TEST SYSTEM
The fish were tested in glass tanks, of 12 and 15 litre capacity. Testing was performed in reconstituted water prepared of deionised water to which salts were added in the following amount per litre: 30 mg calcium sulphate, 30 mg magnesium sulphate, 48 mg sodium bicarbonate, 3 mg potassium chloride. With exception of experiments on trout the water was not aerated during testing. Three to four fish were placed in each tank resulting in the following weights of fish per volume of water:
Rainbow trout: 1. 8 g/Le
Carp: 2.0 g/L
Catfish: 1. 0 g/L
Bluegill: 1.4 g/L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: for Rainbow trout, Carp, Catfish and Bluegill

Validity criteria fulfilled:

not specified

Conclusions:

In this acute toxicity test with Rainbow trout, Carp, Catfish and Bluegill the 96 h LC50 was greater than 100 mg/L. These results are based on nominal concentrations. The test material is practically devoid of acute toxicity to trout, carp, catfish and bluegill when tester and evaluated according to the procedure of Bathe et al.

Executive summary:

The acute toxic effects of FeNaEDDHA to Rainbow trout, Carp, Catfish and Bluegill were determined. The fish were tested in glass tanks of 12 and 15 litre capacity. Testing was performed in reconstituted water prepared of deionised water. Various concentrations of FeNaEDDHA were prepared by adding the test material dissolved in aqua dest. (stock solution). (solubility of active ingr. in water: well miscible) at the appropriate amount ensuring that the total volume in each vessel remained the same.

In this acute toxicity test with Rainbow trout, Carp, Catfish and Bluegill the 96 h LC50 was greater than 100 mg/L. These results are based on nominal concentrations. FeNaEDDHA is practically devoid of acute toxicity to trout, carp, catfish and bluegill when testet and evaluated according to the procedure of Bathe et al. (1974).

Description of key information

LC50(96h) > 120 mg/L (nominal, limit test) for mortality of Danio rerio (OECD 203)

Additional information

In the key study the acute toxic effects of FeNaEDDHA to zebrafish were determined according to the principles of OECD-Guideline 203 and EU method C.1. A limit test with a nominal concentration of 120 mg/L was carried out in a static system. The LC50 for a 96 hour exposure was greater than 120 mg/L and the NOEC was greater than or equal to 120 mg/L for zebrafish.

The supporting acute toxicity study to rainbow trout, carp, catfish and bluegill was performed according to the method reported by Bathe et al. (1974). Various concentrations of FeNaEDDHA were prepared by adding the test material dissolved in aqua dest. (stock solution), at the appropriate amount ensuring that the total volume in each vessel remained the same. The LC50 for a 96 hour exposure was greater than 100 mg/L for rainbow trout, carp, catfish and bluegill.