Refractories, fibers, aluminosilicate

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; silanedione

EC Number:

604-314-4

Cas Number:

142844-00-6

Molecular formula:

amorphous glass Si(n)O(3n+1) polymeric anions bonded to Zr and Al(3+)

IUPAC Name:

oxo[(oxoalumanyl)oxy]alumane; silanedione

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 for quantitative analysis from the control and test group at 0, 24, 48 and 72 hours from fresh media and at 24, 48, 72 and 96 hours from old media. All samples were stored frozen prior to analysis.

Test solutions

Vehicle:

no

Details on test solutions:

A nominal amount of test item (2200 mg) was added to the surface of 22 L of test water to give the 100 mg/L loading rate. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 23 hours and the mixture allowed to stand for 2 hours. Visual observations made on the WAFs indicated that a significant amount of dispersed test item was present in the water column and hence it was considered justifiable to remove the WAF by filtering. At the request of the sponsor the WAF was filtered through two glass wool plugs and two filter papers. A wide bore glass tube, covered at one end with Nescofilm, was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. The glass wool plugs were inserted into the opposite end of the tubing and the WAF removed by mid-depth siphoning (the first 75 to 100 mL discarded) with the use of two filter papers to give the 100 mg/L loading rate WAF. Microscopic observations of the WAF were performed after filtering and showed small particles of test item to be observed. For the 48-Hour renewal, test preparation siphoning was delayed resulting in the standing period exceeding 2 hours. This was considered not to impact the study as sufficient time was taken for the test item to settle out of the water column.

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): 4.6 cm (SD = 0.2)
- Weight at study initiation (mean and range, SD): 0.74 g (SD 0.07)
- Method of breeding: Not at test site.
- Maintenance of the brood fish: Not applicable
- Loading rate: Based on the mean weight value this gave a loading rate of 0.26 g body weight/L.

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: 7.8 to 8.2
Test 100 mg/L: 7.9 to 8.2

Dissolved oxygen:

Control: 10.7 to 11.5 mg O2/L
Test 100 mg/L: 10.3 to 11 mg O2/L

Salinity:

Not specified

Conductivity:

Typically 513 μS/cm at 20 °C

Nominal and measured concentrations:

Nominal: Control and 100 mg/L nominal loading rate
Measured: The dissolved test item may have been one or several components of the test item. Given that toxicity cannot be attributed to a single component or mixture of components but to the test item as a whole, the results were based on nominal loading rates only. Analysis of the fresh test preparations at 0, 24, 48 and 72 hours showed measured test concentrations of between 0.010 and 0.021 mg/L as Aluminium. In the corresponding old test preparations at 24, 48, 72 and 96 hours, measured test concentrations were determined to decline to between 0.0078 and 0.013 mg/L as Aluminium. All values were corrected for the control values due to Aluminium being present in the media.

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 25L 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, 29, 48, 52.5, 72, 76 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 loading rates of 1.0, 10 and 100 mg/L.
- Results used to determine the conditions for the definitive study: There were no sub-lethal effects of exposure during the range-finding test. The results showed no mortalities at 1.0, 10 and 100 mg/L loading rate WAFs. Based on this information, a single loading rate of 100 mg/L was selected for the definitive test. This experimental design conforms to a "Limit test" to confirm that no mortalities or sub-lethal effects of exposure were observed.
Chemical analysis of the test preparations at 0 hours showed measured test concentrations of between not detected and 0.011 mg/L as Aluminium. Measured test concentrations at 24 hours showed values of between not detected and 0.011 mg/L as Aluminium therefore, the test item was considered to be stable at the level to be tested.

Reference substance (positive control):

no

Remarks:

Not a guideline requirement

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

mortality (fish)

Details on results:

Mortality: There were no mortalities in seven fish exposed to a 100 mg/L loading rate WAF for a period of 96 hours.

Sub-lethal effects: There were no sub-lethal effects of exposure observed in seven fish exposed to a 100 mg/L loading rate WAF for a period of 96 hours.

Verification of aluminium concentrations: Analysis of the fresh test preparations at 0, 24, 48 and 72 hours showed measured test concentrations of between 0.010 and 0.021 mg/L as Aluminium. In the corresponding old test preparations at 24, 48, 72 and 96 hours, measured test concentrations were determined to decline to between 0.0078 and 0.013 mg/L as Aluminium. All values were corrected for the control values due to Aluminium being present in the media. The dissolved test item may have been one or several components of the test item. Given that toxicity cannot be attributed to a single component or mixture of components but to the test item as a whole, the results were based on nominal loading rates only.

Vortex depth measurements: The vortex depth was recorded at the start and end of each mixing period and was observed to be a dimple at the water surface on each occasion.

Observations on test item solubility: Observations on the test media were carried out during the mixing and testing of the WAFs. At the start of the mixing period the 100 mg/L preparations were observed to be cloudy off white dispersions. After 23 hours stirring and a 2-Hour standing period the 100 mg/L preparations were observed to remain as cloudy off white dispersions. Visual inspection of the WAFs showed test item to be present. After siphoning using two glass wool plugs and two filter papers a few particles of test item were observed and for the duration of the test, the 100 mg/L preparation was observed to be a very slightly hazy homogenous dispersion. At the start and throughout the test all control solutions were observed to be clear colorless solutions.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

An estimate of the LL50 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):

Time point (hours)	Nominal concentration of test item in sample (mg/L)	Determined concentration of Aluminium in test sample (mg/L Al)	Percentage of nominal concentration (%)
0	Control	0.0106	-
	100	0.0103	-
24 old	Control	0.0123	-
	100	0.0078	-
24 fresh	Control	0.00826	-
	100	0.0113	-
48 old	Control	0.0132	-
	100	0.0087	-
48 fresh	Control	0.00917	-
	100	0.0164	-
72 old	Control	0.00918	-
	100	0.0133	-
72 fresh	Control	0.00706	-
	100	0.0208	-
96 old	Control	0.00781	-
	100	0.0127	-
P. Rec 1	0.0250	0.0259	104
P. Rec 2	0.0250	0.0259	104

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 gave a 96-Hour LL50 value of greater than 100 mg/L loading rate WAF.