Lithium potassium titanium oxide

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05/07/2004-26/07/2004

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:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

(1998)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: ISO 10706

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, crystaline
- Analytical purity: 100 %
- Lot/batch No.: 2D79A
- Expiration date of the lot/batch: 31 October 2004
- Storage condition of test material: At room temperature in the dark

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: blank and 100 mg/L filtrate
- Sampling method: 20 ml taken At the beginning and the end of three 48-hour intervals and one 72-hour interval of nominal days 2 and 4, 7 and 9, 14 and 16, 18 and 21
- Sample storage conditions before analysis: All samples were stored in a deep-freeze until shipment to Solvias AG, Basel, Switzerland.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with supersaturated solutions that were weekly prepared at nominally 100 mg/l. The solutions were magnetically stirred for a minimum of three and a maximum of seven days in the dark prior to testing. Part of the resulting dispersions were then filtered through a paper filter (Schleicher and Schuell 604) to remove the major fraction of non-dissolved test substance particles (> ca. 5 µm). The filtrates were clear and colourless. Test solutions were renewed three times a week.
- Controls: Test medium without test substance or other additives

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Straus, 1820
- Source: In-house laboratory culture with a known history
- Age of parental stock: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood
- Feeding during test. yes
- Food type: 0.25 ml of Chlorella pyrenoidosa suspension containing 2x10^8 cells/ml. Algae suspensions were made by inoculating growth medium with Chlorella pyrenoidosa from a pure culture. The suspensions were continuously aerated and exposed to light (6000-10000 lux; 60-120 µE.m-2.s-1) in a climate room at a temperature of 23 ± 2°C for 2-3 weeks
- Amount: 0.22-0.24 mg C/daphnid/day
- Frequency: daily

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Test conditions

Hardness:

290-360 mg/l CaCO3

Test temperature:

19.5-21.0

pH:

7.5-8.7

Dissolved oxygen:

7.5-10.3

Nominal and measured concentrations:

Nominal: 100 mg/L filtrate
Measured: Analysis of the samples taken from the freshly prepared and 48 or 72-hour old filtrates 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. The concentration measured during the major part of the study was between 3.0 and 3.7 mg/l, except for the samples from the last renewal interval (i.e. days 18 and 21) when the measured concentration ranged between 5.4 and 5.7 mg/l. The time weighed average (TWA) concentration for the 21-day test period was determined to be 4.0 mg/l. Extrapolating this concentration to the concentration of the test substance TERRACESS L resulted in a concentration of 23 mg/l (using the formula: K concentration analysed / 0.76*M K )*M TERRACESS L).

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 ml, all-glass
- Material, size, headspace, fill volume: 50 ml
- Renewal rate of test solution (frequency/flow rate): Three times a week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 20
- No. of vessels per control (replicates): 20


TEST MEDIUM / WATER PARAMETERS
Composition of medium M7:

ISO-medium: the following chemicals (analytical grade) were dissolved in freshly prepared ultra-pure water (tap water
purified by reverse osmosis (milli-RO); Millipore Corp., Bedford, Mass., USA) (mg/l):
CaCl2.2H2O 293.8
MgSO4.7H2O 123.3
NaHCO3 64.8
KCl 5.8
Medium M7: trace elements, macro nutrients and vitamins are added to freshly prepared ISO-medium to reach the
following concentrations: Trace elements (mg/l):
B 0.125
Fe 0.05
Mn 0.025
Li, Rb and Sr 0.0125
Mo 0.0063
Br 0.0025
Cu 0.0016
Zn 0.0063
Co and I 0.0025
Se 0.0010
V 0.0003
Na2EDTA.2H2O 2.5

Macro nutrients (mg/l):
Na2SiO3.9H2O 10.0
NaNO3 0.27
KH2PO4 0.14
K2HPO4 0.18

Vitamins (µg/l):
Thiamine 75.0
B12 1.0
Biotin 0.75

The hardness: 250 mg/l expressed as CaCO3 and the pH: 8.0 ± 0.2 after aeration

- Culture medium different from test medium: no
- Intervals of water quality measurement: start/end; just before/after water removal

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 hours photoperiod daily
- Light intensity: range 700-796 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): survival (immobility and mortalty), reproduction, body length, presence of eggs

VEHICLE CONTROL PERFORMED: not applicable

RANGE-FINDING STUDY

- Results used to determine the conditions for the definitive study: the results obtained from the acute Daphnia study

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

> 4 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

element

Remarks:

Potassium

Basis for effect:

reproduction

Remarks on result:

other: (>WSL)

Effect concentrations 2

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

> 23 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Remarks:

Terracess L

Basis for effect:

reproduction

Remarks on result:

other: (>WSL)

Details on results:

Terracess L caused no effects on reproduction at its maximum solubility in test medium
- Mortality of parent animals: Not more than 3 parental daphnids died during the test period in the controls (15%). Two of them were found dead on the last day of exposure. No parental daphnids died in the TERRACESS L treated test solution. Hence, no treatment related mortality of parental daphnids was observed.
- No. of offspring produced per day per female: the mean number of living young per parent varies from: in blank 0 (day 8) to 82.4 (day 21) and in 100 mg/L filtrate: 1.6 (day 8) to 110.4 (day 21)
- Body length and weight of parent animals: the average body length ( mm) of the parents measured at the end of the test was in blank of 3.9 +/- 0.7 and in 100 mg/L filtrare of 4.0 +/- 0.6
- Other biological observations: No aborted eggs were observed in any of the concentrations tested. Also, no immobilised or dead offspring was recorded.
- Effect concentrations exceeding solubility of substance in test medium: not applicable (no effects observed)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the test, Terracess L did not affect the reproduction of Daphnia magna at a loading rate of 100 mg/L, after 21 days.Due to very low solubility of Terracess L in water, a concentration that can affect the reproduction of daphnids could not be reached.