Lithium potassium titanium oxide

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30/06/2003-04/07/2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium Potassium Titanium Oxide

EC Number:

445-620-6

Cas Number:

39318-30-4

Molecular formula:

Hill Empirical formula: K(0.5-0.7) Li(0.27) Ti(1.73) O(3.8-3.95) CAS Empirical formula: K(0.5-0.7) Li(0.27) Ti(1.73) O(3.8-3.95)

IUPAC Name:

Lithium Potassium Titanium Oxide

Details on test material:

- Name of test material (as cited in study report): TERRACESS L
- Substance type: white powder
- Physical state: solid

- Lot/batch No.: 2D79A
- Expiration date of the lot/batch: 11 April 2004
- Storage condition of test material: At room temperature in the dark

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 5 µm filtered solution prepared from a 100 mg/l suspension and the control.
- Sampling method: 20 ml from the approximate centre of the test vessels
- Sample storage conditions before analysis: stored in a deep-freeze until shipment to Solvias AG, Basel, Switzerland

Test solutions

Vehicle:

no

Details on test solutions:

Identity and concentration of auxiliary solvent for dispersal: None.
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A 5 µm filtered solution prepared at a loading rate of 100 mg/l (filtered after 3 days of stirring) and dilutions containing 0.1, 1.0 and 10% of the filtrate.

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Strain: Teleostei, Cyprinidae
- Source: Zodiac, proefacc, "De Haar Vissen", L.U. Wageningen, the Netherlands.
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): 2.0 ± 0.2 cm
- Weight at study initiation (mean and range, SD): 0.21 ± 0.04 g
- Method of breeding: F1 from a single parent-pair bred in UV-treated water.
- Feeding during test: No feeding from 48 hours prior to the test and during the total test period.

ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): yes
- Type and amount of food: Trouvit
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

250 mg CaCO3/L

Test temperature:

Blank control: 20.3 (day 0) to 20.9 (day 4)
0.1 % filtrate: 20.3 (day 0)
1 % filtrate: 20.4 (day 0)
10% filtrate: 20.7 (day 0)
100 % filtrate: 20.6 (day 0) to 21.0 (day 4)
Test groups represent percentages of a 5 µm filtered solution prepared at a nominal loading of 100 mg/l.

pH:

Blank control: 7.2-7.9
100 % filtrate: 7.1-8.3

Dissolved oxygen:

Blank control: 6.7-8.8
100 % filtrate: 6.3-8.8

Nominal and measured concentrations:

The nominal concentrations of Terracess L were prepared as follows: A 5 µm filtered solution prepared at a loading rate of 100 mg/l (3 days stirring) and dilutions containing 0.1, 1.0 and 10% of the filtrate.
The blank-filtrate: Test medium without test substance or other additives (0 mg/l).
Analysis of the samples taken from the 5 µm filtrate prepared at a loading rate of 100 mg/l showed that measured concentrations based on Lithium and Titanium were below the detection limit of the analytical method, i.e. below 0.1 mg/l. The Potassium concentration could be measured and remained stable at 3 mg/l during the 96-hour test period.
Extrapolating this concentration to the concentration of the test substance TERRACESS L resulted in a concentration of 13 mg/l (using the formula: K concentration analysed / 0.76* M K )* M TERRACESS L).

Details on test conditions:

TEST SYSTEM
- Test vessel: 6.5 litres, all-glass.
- Aeration: The test media were not aerated during the test.
- Type of flow-through: static
- No. of organisms per vessel: 3 ( for the 0.1, 1 and 10 % of the filtrate) and 7 ( for the blank-control and 100 mg/L filtered through 5 um filter)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: Control and 100 mg/l filtrate: 0.37 g fish/litre, i.e. 7 fish per 4 litres of test medium; Dilutions: 0.16 g fish/litre, i.e. 3 fish per 4 litres of test medium.


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO-medium, formulated using Milli-Ro water (tap-water purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA) with the following composition:
CaCl2.2H2O 293.8 mg/l
MgSO4.7H2O 123.3 mg/l
NaHCO3 64.8 mg/l
KCl 5.8 mg/l


- Culture medium different from test medium: no
- Intervals of water quality measurement: pH, nitrate and nitrite concentration and ammonia concentration: once a week. Temperature: every day.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod daily

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study: no
- Test concentrations: Test groups (0.1; 1; 10 and 100) represent percentages of a 5 µm filtered solution prepared at a nominal loading of 100 mg/l (filtrate).
- Results used to determine the conditions for the definitive study: No mortality or clinical effects observed in the limit/range finding test.

Reference substance (positive control):

yes

Remarks:

pentachlorophenol (PCP)

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 3 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

element

Remarks:

Potassium

Basis for effect:

mortality (fish)

Remarks on result:

other: (> WSL)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 17.62 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

Terracess L

Basis for effect:

mortality (fish)

Remarks on result:

other: (> WSL)

Details on results:

- Behavioural abnormalities: none
- Mortality of control: no
- Other adverse effects control: no

Results with reference substance (positive control):

- Results with reference substance valid? yes
Under the conditions of the present test PENTACHLOROPHENOL induced no lethal effects in carp at or below 0.15 mg/l. The 96h-LC50 for carp exposed to PCP was 0.21 mg/l (95 % confidence interval between 0.19 and 0.27 mg/l). The 24h-LC50 was 0.24 mg/l (95% confidence interval between 0.21 and 0.30 mg/l), and remained unchanged until 72h. The range of the 96h-LC50 for carp is generally between 0.10 and 0.46 mg/l based on historical data of reference tests performed approximately every 3 months from April 1988 until the end 2000, and annually since then. The response observed in carp originating from the present batch falls within this range.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present test TERRACESS L induced no visible effects in carp at or below a 5 µm filtered solution prepared at a loading rate of 100 mg/l.
The 95-h LC50 was above WSL .