Bis(acetato-O)hydroxyaluminium

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:

2019-02-11 to 2019-02-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

17 July 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

30 May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

October 2016

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling method: For determination of the test item concentration samples were taken from the test solution and control at the start and at the end of the test (5×50 mL at the start and 5×60 mL at the end).

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution used in the test was prepared by mechanical dispersion without using of any solubilising agent. The test item is poorly water soluble material. For preparation of the test solution a supersaturated solution (100 mg/L nominal loading) was first prepared by dispersing/dissolving an amount of 0.3 g test item in 3000 mL dilution water (ISO Medium). This solution was agitated by orbital shaker for approx. 3 days and then the non-dissolved test material was separated by filtration through a membrane filter (0.22 μm) in order to obtain the saturated test solution. Untreated control ran parallel in the test. After the formulation procedure the test animals were immediately introduced into test solution.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: Akvárium magazin Kft. (Pasaréti Gyula) 1222 Budapest, Dévény u. 36.
- Age at study initiation: Juveniles were used
- Length at study initiation (range): 2 ± 1 cm

ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions: same conditions as used during the exposure period
- Type of food during acclimation: During holding, fish were fed with appropriate, commercial diet for fish
- Feeding frequency during acclimation: Fish were fed at least three times per week until one day before the test start.
- Health during acclimation: The health of the breeding was continuously monitored and any mortality or abnormal behaviour recorded. No significant mortality (less than 5 % of population) occurred in seven days before the start of the experiment, therefore the batch was considered to be acceptable for testing.

FEEDING DURING TEST : The fish were not fed during the test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

249 mg/L (as CaCO3)

Test temperature:

21.7 – 22.3 °C

pH:

5.84 – 7.69

Dissolved oxygen:

64.9 – 81.4 % of the air saturation

Salinity:

Not applicable.

Conductivity:

No data.

Nominal and measured concentrations:

Nominal: 100 mg/L
Measued (geometric mean): 1.46 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquariums with 3 litre test liquid.
- Aeration: Slight aeration was used in the test item treated aquarium from the 72-h observation period as decrease of oxygen concentration (measured value at this day was 65.7 mg/L) was noted in this aquarium.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): no replicates were used
- No. of vessels per control (replicates): no replicates were used
- Biomass loading rate: The loading did not exceed 1.0 g/L.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to guideline 203

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light: 8 h dark

EFFECT PARAMETERS MEASURED: Fish were observed at approximately 4, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1.46 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1.31 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: calculated value for anhydrous substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1.46 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1.31 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: calculated value for anhydrous substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 1.46 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 1.31 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: calculated value for anhydrous substance

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Observations on body length: The measured body length of the fish were within the range of 2.20 – 2.75 cm which is recommended for the species by the test guideline (OECD No. 203).
- Observations on body weight: The loading of the test-aquariums was calculated and was 0.64 g/L in the control and 0.67 g/L in the test item treated group
- Mortality: There were no mortalities or any sub-lethal effects observed in 10 fishes in the control group or in 10 fishes exposed to the saturation concentration (equivalent to 100 mg/L nominal concentration; 1.46 mg/L measured) during the 96-h test period

Sublethal observations / clinical signs:

Validity of the Study

- No mortality was observed in the control group during the test.

- The dissolved oxygen concentration in the test solutions did not fall below 60% of air saturation value during the study.

- No significant change (more than one unit) in the pH value was observed during the test.

All acceptance criteria were met therefore the study was considered to be valid.

Analytical Results

During the experiment the test item was tested at aquatic saturation (equivalent to 100 mg/L nominal concentration). A concurrent control ran.

The measured concentrations of the test item Aluminium hydroxide diacetate hydrate was 1.74 mg/L at the start and 1.22 mg/L at the end of the test.

Exposure concentration of the test item was calculated as the geometric mean of the measured start and end concentrations and was determined to be 1.46 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

In this 96-hour static acute toxicity test on Zebrafish (Danio rerio) the test item Aluminium hydroxide diacetate hydrate had no toxic effect on fish at aquatic saturation (measured value: 1.46 mg/L; equivalent to 100 mg/L nominal concentration). Accordingly, the 96-h LC50 value was determined to be > 1.46 mg/L (equivalent to 100 mg/L nominal concentration). The 96-h NOEC was determined to be 1.46 mg/L (equivalent to 100 mg/L nominal concentration). All validity criteria were met.

Executive summary:

The acute toxicity of Aluminium hydroxide diacetate hydrate on Zebrafish (Danio rerio) was evaluated according to OECD guideline 203 (reference 6.1.1-1). A limit test was performed in which the test animals were exposed to aqueous test media containing the test item for 96 hours at the limit of its solubility in the test medium (i.e. saturation) plus a control in order to demonstrate that the test item is not toxic to Zebrafish up to at least the saturation concentration. In the limit test a single concentration at saturation corresponding to 100 mg/L nominal concentration of the test item was used. The concentration of the saturated test solution was analytically determined to be 1.46 mg/L (calculated as the geometric mean of start and end concentrations). Fish were exposed to aqueous test media containing the test item for 96 hours in a static test. Ten fish were exposed to the test concentration or run as control (no replicates were used). Fish were observed at approximately 4, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality.

Mortality and any sub-lethal effects were not observed during the 96-h exposure period either in the treated or in the control group. Accordingly, the 96-h NOEC was determined as 1.46 mg/L (equivalent to 100 mg/L nominal concentration). The LOEC and the LC50 values were determined to be higher than 1.46 mg/L (equivalent to > 100 mg/L nominal concentration). Based on the molecular weight the recalculated NOEC for the anhydrous substance is 1.31 mg/L. The LOEC and the LC50 for the anhydrous substance was calculated to be higher than 1.31 mg/L. All validity criteria were met.

Description of key information

In this 96-hour static acute toxicity test on Zebrafish (Danio rerio, reference 6.1.1 -1) the test item Aluminium hydroxide diacetate hydrate had no toxic effect on fish at aquatic saturation (measured value: 1.46 mg/L; equivalent to 100 mg/L nominal concentration). Accordingly, the 96-h LC50 value was determined to be >1.46 mg/L (equivalent to 100 mg/L nominal concentration). The 96-h NOEC was determined to be 1.46 mg/L (equivalent to 100 mg/L nominal concentration). Based on the molecular weight the recalculated NOEC for the anhydrous substance is 1.31 mg/L. The LOEC and the LC50 for the anhydrous substance was calculated to be higher than 1.31 mg/L.

Additional information

The acute toxicity of Aluminium hydroxide diacetate hydrate on Zebrafish (Danio rerio) was evaluated according to OECD guideline 203 (reference 6.1.1-1). A limit test was performed in which the test animals were exposed to aqueous test media containing the test item for 96 hours at the limit of its solubility in the test medium (i.e. saturation) plus a control in order to demonstrate that the test item is not toxic to Zebrafish up to at least the saturation concentration. In the limit test a single concentration at saturation corresponding to 100 mg/L nominal concentration of the test item was used. The concentration of the saturated test solution was analytically determined to be 1.46 mg/L (calculated as the geometric mean of start and end concentrations). Fish were exposed to aqueous test media containing the test item for 96 hours in a static test. Ten fish were exposed to the test concentration or run as control (no replicates were used). Fish were observed at approximately 4, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality.

Mortality and any sub-lethal effects were not observed during the 96-h exposure period either in the treated or in the control group. Accordingly, the 96-h NOEC was determined as 1.46 mg/L (equivalent to 100 mg/L nominal concentration). The LOEC and the LC50 values were determined to be higher than 1.46 mg/L (equivalent to > 100 mg/L nominal concentration). Based on the molecular weight the recalculated NOEC for the anhydrous substance is 1.31 mg/L. The LOEC and the LC50 for the anhydrous substance was calculated to be higher than 1.31 mg/L. All validity criteria were met.