Lithium nickel potassium oxide

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20th September 2019 to 06th February 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 2: Semi-static method)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Details on sampling:

The concentration control analysis was performed with all test groups.
The test substance contains lithium and nickel. The nickel content was determined in prepared
test solutions.
Sampling for concentration control analysis was performed for 2 renewal intervals (Interval 1
and Interval 4). For the first interval samples were collected within 30 min before insertion of
the test organisms (0 h) and after 24 hours from all test vessels. For the fourth interval, samples
were collected from fresh test solutions within 30 min of test solution renewal at 72 h and after
96 hours from all test vessels.
The samples for analysis were collected with a glass pipette inserted in the middle of the test
vessel. The required sample volume of 5mL was deposited into 22 mL glass ampoules.

Vehicle:

no

Details on test solutions:

TEST SUBSTANCE PREPARATIONS
Test groups: 0 (control) and 100 mg/L as nominal concentrations based on test substance mass without a correction for purity
Test replicates: One aquarium with 7 fish per test group
Reason for the selection of the
test concentrations:
According to OECD-guideline, the highest suggested test
concentration is 100 mg/L for a limit test.

TEST SUBSTANCE PREPARATIONS
The test treatments were prepared separately for each test vessel. The defined volume of test water was filled into the test vessel. An aliquot from the test water in the test vessel was taken and mixed with the test substance using a high shear mixer (Ultra Turrax, IKA Werke GmbH & Co. KG, Germany) and the mixture was poured into the test vessel and the whole test batch
was homogenized again with an overhead stirrer (RW 20, IKA Werke GmbH & Co. KG, Germany or similar). The test treatments were then stirred for 2 days to ensure that the saturated test solution was obtained. Undissolved test substance was removed by filtration with a membrane filter (Whatman OE67,
pore width 0.45 μm). At least the first 500 mL of filtered solution were discarded (used to condition the filter). The aqueous fraction was inspected visually for the presence of any undissolved test substance by observing the scattering of a laser light through the test solution (Tyndall effect) and the Tyndall effect was negative. The aqueous fraction of the test solution,
after separation of the undissolved material, was considered the water saturated fraction (WSF) in test media.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Test species: Zebrafish (Danio rerio)

The fish were acclimatized to the testing conditions including test water, temperature and light
regime for at least 14 days. The general conditions during acclimatization were as follows:
Housing: Prior to testing, the batch of fish are housed in in a glass tank (approx. 45 L) receiving a continuous supply of fresh test water.
Photoperiod: 16 hours light, 8 hours dark
Water quality: The water used for housing and test purposes is nonchlorinated charcoal filtered drinking water (Frankenthal, Germany) mixed with deionized water and aerated to achieve the following water characteristics. The mixed test water is sanitized by UV treatment prior to entering the aquaria.
Total hardness: Approx. 1 mmol/L = 100 mg/L CaCO3
Conductivity: Approx. 250 μS/cm (at 25°C)
Ca content: Approx. 40 mg/L
Mg content: Approx. 5 mg/L
Acid capacity: Approx. 2.5 mmol/L
pH-value: Generally 7.5 – 8.5
Oxygen content: >80% saturation
TOC: Generally <2mg/L
Temperature: 23 ±1°C

Test type:

semi-static

Water media type:

other: The water used for housing and test purposes is nonchlorinated charcoal filtered drinking water (Frankenthal, Germany) mixed with deionized water and aerated to achieve the following water characteristics. The mixed test water is sanitized by UV treatment

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

96 hours semi-static, 24 hour test solution renewal

Hardness:

Total hardness: Approx. 1 mmol/L = 100 mg/L CaCO3

Test temperature:

23 ±1°C

pH:

Generally 7.5 – 8.5

Dissolved oxygen:

The concentrations of dissolved oxygen were maintained above 60% of the maximum
saturation at the test temperature of 22ºC (i.e. > 5.3 mg/L).

Conductivity:

Approx. 250 μS/cm (at 25°C)

Nominal and measured concentrations:

TEST SUBSTANCE PREPARATIONS
Test groups: 0 (control) and 100 mg/L as nominal concentrations based on test substance mass without a correction for purity
Test replicates: One aquarium with 7 fish per test group
Reason for the selection of the
test concentrations:
According to OECD-guideline, the highest suggested test
concentration is 100 mg/L for a limit test.

TEST SUBSTANCE PREPARATIONS
The test treatments were prepared separately for each test vessel. The defined volume of test water was filled into the test vessel. An aliquot from the test water in the test vessel was taken and mixed with the test substance using a high shear mixer (Ultra Turrax, IKA Werke GmbH & Co. KG, Germany) and the mixture was poured into the test vessel and the whole test batch
was homogenized again with an overhead stirrer (RW 20, IKA Werke GmbH & Co. KG, Germany or similar). The test treatments were then stirred for 2 days to ensure that the saturated test solution was obtained. Undissolved test substance was removed by filtration with a membrane filter (Whatman OE67,
pore width 0.45 μm). At least the first 500 mL of filtered solution were discarded (used to condition the filter). The aqueous fraction was inspected visually for the presence of any undissolved test substance by observing the scattering of a laser light through the test solution (Tyndall effect) and the Tyndall effect was negative. The aqueous fraction of the test solution,
after separation of the undissolved material, was considered the water saturated fraction (WSF) in test media.

Details on test conditions:

EXPERIMENTAL PROCEDURE
Test temperature: 22°C
Test water: non chlorinated charcoal-filtered drinking water from the municipal water works of the city of Frankenthal mixed with deionized water, hardness approx. 100 mg/L as CaCO3, pH generally 7.5 - 8.5
Test vessels: Approx. 10 Liter stainless steel aquaria (29 x 21 x 22 cm)
Test volume: Approx.10 L
Loading: 7 Fish/ test vessel, max. approx. 0.091 g fish/L
Randomization: The test organisms were introduced into the test vessels
according to a randomization plan prepared by using a program of the laboratory data evaluation group of the testing facility.
Feeding: None
Photoperiod 16h light, 8h dark
Light intensity: Approx. 84 – 308 Lux (the light intensity is determined in regular intervals at the surface of the aquaria)
Oxygen content: >60% ASV (air saturation value)
Aeration: Continuous slight aeration via glass capillary.
pH-value: No adjustment of the pH-value
Route of exposure: Semi-static daily renewal exposure via test water
Reason: To help ensure constant exposure conditions
throughout the test, this study was conducted as a semi-static renewal
exposure. The renewal period was 24 hours.


OBSERVATIONS AND MEASUREMENTS
The fish were observed for mortality and toxic signs (changes appearance and abnormal
behavior in comparison to the control group) within 1 hour after start of exposure and 6, 24, 48,
72 and 96 hours after start of exposure. Fish were considered dead if there was no visible
movement and no reaction after touching.
Temperature, oxygen content and pH-value were measured in each test vessel (at the start
and the end of each interval) and the appearance of the test solutions and dissolution behavior
of the test substance was observed.
At the end of exposure the body wet weight and total length of a representative sample of fish
were determined. The representative sample consisted of all surviving fish from the lowest
concentration and control group.

VALIDITY CRITERIA
All the following validity criteria were met and the experiment is considered valid.
Exposure criteria
• The pH was not varied by more than one unit
• Oxygen concentration ≥ 60% of the saturation value
• All test vessels are identical.
• Fish were randomly assigned to all test vessels.
• No feeding during exposure.
Control performance criteria
• At least one negative control group was included in the test design.
• ≤ 10 % mortality in the control group

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

ANALYTICAL CONCENTRATION CONTROL
Since the test substance is a poorly water soluble inorganic chemical, only the dissolved content of the constituent element (nickel) was analytically determined. All reasonable efforts were taken to produce a saturated solution of the test substance in test media, following the guidance in OECD 23. According to OECD 23, for tests with chemicals that can not be
quantified by analytical methods at the concentrations causing effects, the effect concentration can be expressed based on the nominal concentrations (the loading rate). According to the preliminary information of the Competence Center Analytics of BASF SE, the component (nickel) was measured at the tested loading rate, which indicates that test item must have been present.

DISSOLUTION BEHAVIOR
All test treatments were visibly clear over the entire exposure period and no undissolved material was observed.

CONCLUSION
In a 96 hour acute toxicity study, zebrafish (Danio rerio) were exposed to KDLNO at a loading rate of 0 (control) and 100 mg/L under static renewal conditions in accordance with the OECD 203 test guideline. The water pH, temperature and dissolved oxygen were within acceptable guideline specifications.

The 96 hour LC50 / LL50 was >100 mg/L based on the loading rate of the test substance.

The results in this study are consistent with all validity criteria and the test is valid according to the guidelines of this study. No deviations from test guidelines or other incidents occurred during the course of the reported test which may have influenced the results.

Validity criteria fulfilled:

yes

Conclusions:

The 96 hour LC50 was >100 mg/L based on the loading rate of the test substance.

Executive summary:

KDLNO – Acute Toxicity Study in the Zebrafish

(Danio rerio)

 

Guidelines: OECD 203

Commission Regulation (EC) No 440/2008, C. 1

 

Test groups: 0 (control), 100 mg/L as loading rate based on test substance mass without correction for purity.

 

Test Results: The following effect concentrations (mg/L) were obtained

based on loading rate:

LC50 /LL50 (96 h): >100 mg/L

Description of key information

KDLNO – Acute Toxicity Study in the Zebrafish

(Danio rerio)

 

Guidelines: OECD 203

Commission Regulation (EC) No 440/2008, C. 1

 

Test groups: 0 (control), 100 mg/L as loading rate based on test substance mass without correction for purity.

 

Test Results: The following effect concentrations (mg/L) were obtained

based on loading rate:

LC50 /LL50 (96 h): >100 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

100 mg/L