Aluminum chloride, basic, reaction products with silica

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

oxo[(oxoalumanyl)oxy]alumane

EC Number:

614-074-2

Cas Number:

675106-31-7

Molecular formula:

UVCB

IUPAC Name:

oxo[(oxoalumanyl)oxy]alumane

Test material form:

solid: fibres

Sampling and analysis

Analytical monitoring:

yes

Remarks:

Aluminium content assessed in test samples using ICP-MS

Details on sampling:

Water samples were taken from the control and 100% v/v saturated solution test vessel at 0, 24, 48 and 72 hours from fresh media and at 24, 48, 72 and 96 hours from old media for quantitative analysis. The 0, 24, 48 and 72-Hour samples were stored frozen prior to analysis with the 96-Hour samples.

Test solutions

Vehicle:

no

Details on test solutions:

A nominal amount of test item (1100 mg) was dispersed in 22 L of test water with the aid of propeller stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and any undissolved test item was removed by filtration through a 0.2 μm Sartorius Sartopore filter (first approximate 1 L used to pre-condition the filter was discarded) to give a 100% v/v saturated solution.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Strain: Not applicable
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Age at study initiation (mean and range, SD): Not specified
- Length at study initiation (length definition, mean, range and SD): 4.8 cm (SD = 0.2)
- Weight at study initiation (mean and range, SD): 0.85 g (SD 0.11)
- Method of breeding: Not at test site.
- Maintenance of the brood fish: Not applicable

ACCLIMATION
- Acclimation period: 5 to 12 April 2021
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food during acclimation: Commercial trout pellets
- Feeding frequency during acclimation: Not specified
- Health during acclimation (any mortality observed): There were no mortalities in the 7 days prior to the start of the test

FEEDING DURING TEST (as applicable)
- Fish were not fed during the test and for around 26 hours ahead of the definitive test

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

Standard as per OECD Guidelines

Post exposure observation period:

None required

Test conditions

Hardness:

Approximately 140 mg/L as CaCO3

Test temperature:

13 to 14°C

pH:

Control: 7.6 to 8.0
Test 100 % (v/v): 7.9 to 8.4

Dissolved oxygen:

Control: 10.3 to 11.7 mg O2/L
Test 100% (v/v): 10.1 to 10.9 mg O2/L

Salinity:

Not specified

Conductivity:

Typically 513 μS/cm at 20 °C

Nominal and measured concentrations:

Nominal: Control and 0.045 mg/L as aluminium (100 % v/v, 50 mg/L)
Measured: Control and 0.016 mg/L as aluminium

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria
- Type (delete if not applicable): open although covered to reduce evaporation
- Material, size, headspace, fill volume: 20L in 25 to 30L aquaria
- Aeration: Aerated using narrow bore glass tubes
- No. of organisms per vessel: 7
- 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: Not specified

TEST MEDIUM / WATER PARAMETERS
- The test water used for both the range-finding and definitive tests was the same as that used to maintain the stock fish.

Laboratory tap water was dechlorinated by passage through an activated carbon filter (Fleck 2750 Duplex Dechlorination unit) and partly softened (Elga Nimbus 1248D Duplex Water Softener) giving water with a total hardness of approximately 140 mg/L as CaCO3. After dechlorination and softening the water was passed through a series of computer controlled plate heat exchangers to achieve the required temperature.

OTHER TEST CONDITIONS
- Adjustment of pH: Not required
- Photoperiod: The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.
- Light intensity: Not specified

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Any mortalities and sub-lethal effects of exposure were recorded at 1, 3, 6, 24, 30, 48, 53, 72, 78 and 96 hours after the start of exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit concentration
- Justification for using less concentrations than requested by guideline: Limit tests are acceptable in the OECD test guideline.
- Range finding study
- Test concentrations: In the range-finding test fish were exposed to a series of nominal test concentrations of 0.10, 1.0, 10 and 100% v/v saturated solution for a period of 96 hours.
- Results used to determine the conditions for the definitive study: The results showed no mortalities at the test concentrations of 0.10, 1.0, 10 and 100% v/v saturated solution. Based on this information, a single test concentration of 100% v/v saturated solution was selected for the definitive test. This experimental design conforms to a "Limit test" to confirm that at the highest attainable test concentration, no mortalities or sub-lethal effects of exposure were observed.

Reference substance (positive control):

no

Remarks:

Not a guideline requirement

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.016 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

element

Remarks:

Aluminium

Basis for effect:

mortality (fish)

Details on results:

Mortality: There were no mortalities in seven fish exposed to a test concentration of 0.016 mg/L as Aluminium for a period of 96 hours.

Sub-lethal effects: There were no sub-lethal effects of exposure observed in the test.

Verification of aluminium concentrations: The substance is considered as insoluble and a UVCB with variable composition (which includes aluminium) and as such was considered to be pure and as a result, a saturation solution approach was used. The results of the alumina release represent the test item as a whole, with relatively low levels of alumina released into the solution at saturation concentration reflecting the low inherent solubility of the substance despite high alumina content. Analysis of the test preparations at 0, 24, 48 and 72 hours fresh showed measured test concentrations to range from 0.015 to 0.018 mg/L as Aluminium. There was no significant change in the measured concentrations at 24, 48, 72 and 96 hours in the old media and so the results are based on the average fresh measured test concentration only. Due to the presence of Aluminium in the control in the original samples, duplicate test samples were analyzed. Duplicate samples confirmed Aluminium to be present in the control however, this is taken to be representative of normal levels in the test media. As a result of this and as a standard was removed in the calibration of the initial analysis, duplicate results were used for reporting. All measured concentrations in the test samples were corrected for control values due to the presence of Aluminium in the media.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

An estimate of the LC50 values was given by inspection of the mortality data.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Definitive test results (analytical verifications):

Sample description	Time point (Hours)	Concentration detected (mg/L Al)
Control	0	0.0132
100% (v/v) saturated solution		0.0183
Control	24 old	0.0145
100% (v/v) saturated solution		0.0227
Control	24 fresh	0.0141
100% (v/v) saturated solution		0.0162
Control	48 old	0.0124
100% (v/v) saturated solution		0.0173
Control	48 fresh	0.0112
100% (v/v) saturated solution		0.0159
Control	72 old	0.0126
100% (v/v) saturated solution		0.0142
Control	72 fresh	0.0111
100% (v/v) saturated solution		0.0148
Control	96 old	0.0114
100% (v/v) saturated solution		0.0150

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The test was considered to be valid given that none of the control fish died or showed signs of stress during the test and that the oxygen concentration at the end of the test was ≥60% of ASV (6.2 mg O2/L) in the control and test vessels.

Conclusions:

The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and based on the average fresh measured test concentration gave a 96 hour LC50 of greater than 0.016 mg/L as Aluminium (> 50 mg/L as nominal loading rate).