Aluminum chloride, basic, reaction products with silica

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

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.2 (Acute Toxicity for Daphnia)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation 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

Details on sampling:

Samples were taken from the control and the 100% v/v saturated solution test group from the bulk test preparation at 0 hours and from the pooled replicates at 48 hours for quantitative analysis. All 0-Hour samples were stored frozen and taken for analysis with the 48-Hour samples. Duplicate sets of samples were taken at 0 and 48 hours and stored frozen for further analysis if necessary.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- A nominal amount of test item (550 mg) was dispersed in 11 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 (the 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):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Straus
- Justification for species other than prescribed by test guideline: Standard as per test guideline
- Age at study initiation (mean and range, SD): Less that 24 hours old
- Weight at study initiation (mean and range, SD): Not specified
- Length at study initiation (length definition, mean, range and SD): Not specified
- Stage and instar at study initiation: First instar
- Method of breeding: Obtained from in house cultures and conditions ensured that reproduction was by parthenogenesis.
- Source: In-house cultures
- Age of parental stock (mean and range, SD): Not specified
- Feeding during test
- Food type: No feeding during test

ACCLIMATION
- Acclimation period: Not specified
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: Each culture was fed with a mixture of algal suspension (Raphidocelis subcapitata) and GEMMA Micro 300 fish food suspension.
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): None noted

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS: Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Remarks on exposure duration:

Standard as per OECD guideline

Post exposure observation period:

Not required

Test conditions

Hardness:

The reconstituted water had an approximate theoretical total hardness of 250 mg/L as CaCO3.

Test temperature:

Maintained at approximately 19 to 20°C throughout the test

pH:

Control: 7.3 to 7.9
Test (0.14 mg/L as aluminium): 7.6 to 7.9

Dissolved oxygen:

Control: 8 to 9.3 mg O2/L
Test (0.14 mg/L as aluminium): 9.2 to 9.5 mg O2/L

Salinity:

Not specified

Conductivity:

Not specified

Nominal and measured concentrations:

Nominal: Control and 0.19 mg/L as aluminium (loading rate 50 mg/L)
Measured: Control and 0.14 mg/L as aluminium

Details on test conditions:

TEST SYSTEM
- Test vessel: 150 mL glass vessels
- Type (delete if not applicable): open although covered to reduce evaporation
- Material, size, headspace, fill volume: 150 mL vessels containing 100 mL of test or control preparations.
- Volume of solution: 100 mL
- Aeration: No
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: Not specified

TEST MEDIUM / WATER PARAMETERS
- Reconstituted water (ISO media) used for the range-finding and definitive tests. The reconstituted water had a pH of 7.8 ±0.2 adjusted (if necessary) with NaOH or HCl and was aerated until the dissolved oxygen concentration was approximately air-saturation value. The reconstituted water had an approximate theoretical total hardness of 250 mg/L as CaCO3.

OTHER TEST CONDITIONS
- Adjustment of pH: Only where necessary in stock water
- 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: between 200 and 1200 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Any immobilization or adverse reactions to exposure were recorded at 24 and 48 hours after the start of exposure. The criterion of effect used was that Daphnia were considered to be immobilized if they were unable to swim within 15 seconds after gentle agitation.

VEHICLE CONTROL PERFORMED: No as no vehicle utilised

RANGE-FINDING STUDY
- Test concentrations: Control, 0.1, 1.0, 10 and 100% v/v saturated solution
- Results used to determine the conditions for the definitive study: No immobilization was observed at the test concentrations of 1.0, 10 and 100% v/v saturated solution however; a single immobilization was observed at 0.10% v/v saturated solution.
Sub-lethal effects of exposure were observed in the control, 0.10, 1.0 and 10% v/v saturated solution test concentrations. These responses were trapping at the surface and reduced mobility. Given that effects were also observed in the control and no effects were observed in the 100% v/v saturated solution test concentration, effects seen are considered not to be test item related.
Based on this information, a single test concentration of four replicates, of 100% v/v saturated solution was selected for the definitive test. This experimental design conforms to a "Limit test" to confirm that at highest attainable test concentration, no significant immobilization was observed.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.14 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

element

Remarks:

Aluminium

Basis for effect:

mobility

Details on results:

Verification of test solutions:
The substance is considered as insoluble and a UVCB with variable composition. The batch of test sample used in the study had a high concentration of Alumina 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 preparation at 0 hours showed a measured test concentration of 0.14 mg/L as Aluminium. There was no significant change in the measured concentration at 48 hours and so the results are based on the 0-Hour measured test concentration only.

Immobilisation data:
There was no significant immobilization in 20 daphnids exposed to a test concentration of 0.14 mg/L as Aluminium for a period of 48 hours (5% immobilization observed).

Results with reference substance (positive control):

A positive control study used potassium dichromate as the reference item at concentrations of 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L. The positive control was conducted between 05 January 2021 and 29 January 2021 and provided a 48 hour EC50 of 0.50 mg/L.

Analysis of the immobilization data was carried out using the Weibull analysis using linear maximum-likelihood regression at 24 and 48 hours. All statistical analysis was carried out using the ToxRat Professional computer software package. The results from the positive control with potassium dichromate were within the normal range for this reference item.

Reported statistics and error estimates:

Due to the nature of the data it was not possible to calculate the slope and error of response curve at 24 and 48 hours.

Any other information on results incl. tables

Cumulative immobilisation observed in the definitive test:

0-hour measured concentration (mg/L as aluminium)	48 hours
	Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate)						Observations
	R1	R2	R3	R4	Total	%	R1	R2	R3	R4
Control	0	0	0	0	0	0	5N	5N	5N	5N
0.14	0	0	1	0	1	5	5N	5N	5N	5N

Analytical results of test samples

Time point (hours)	Nominal concentration of test item in sample (% v/v saturated solution)	Determined concentration of aluminium in test sample (mg/L Al)	Percentage of nominal concentration (%)
0	Control	< LOQ	-
	100	0.143	-
48	Control	<LOQ	-
	100	0.148	-
P. Rec 1	0.0250	0.0253	101
P. Rec 2	0.0250	0.0260	104

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The test was considered to be valid given that none of the control daphnids showed immobilization or other signs of disease or stress and that the oxygen concentration at the end of the test was equal to or greater than 3 mg/L in the control and test vess

Conclusions:

The acute toxicity of the test item to the freshwater invertebrate Daphnia magna has been investigated and based on the 0-Hour measured test concentration gave a 48 hour EC50 value of greater than 0.14 mg/L as Aluminium (> 50 mg/L as nominal loading rate). This study showed that there were no toxic effects at saturation.