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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 - 24 April 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L and blank-control
- Sampling method: 10 mL samples were taken from the approximate centre of the test vessels at the start (t=0) and end of the limit test (96 hr).
- Sample storage conditions before analysis: Samples were stored at room temperature until transportation to the analysis laboratory.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A solution of 100 mg/L was prepared by dissolving the test material (white crystals) in test medium with no special treatment other than careful mixing.
- Eluate: Not applicable
- Differential loading: Not applicable
- Controls: Test medium without test substance or other additives (blank-control)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)):
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Test material was completely soluble in test medium
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Strain: Cyprinus carpio
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and research centre, the Netherlands
- Age at study initiation (mean and range, SD): No data
- Length at study initiation (length definition, mean, range and SD): 2.3 ± 0.3 cm (mean of 10 fish from the batch used for the test)
- Weight at study initiation (mean and range, SD): 0.38 ± 0.11 g (mean of 10 fish from the batch used for the test)
- Method of breeding: Single parent-pair bred in UV-treated water
- Feeding during test: No
- Food type: Not applicable
- Amount: Not applicable
- Frequency: Not applicable

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): No data
- Type and amount of food: Pelleted fish food and/or artemia (until 24 hours before the test initiation)
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): Less than 5%

QUARANTINE (wild caught)
- Duration: Not applicable
- Health/mortality: Not applicable
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
None
Hardness:
250 mg/L (as CaCO3)
Test temperature:
21 deg C (day 0)
pH:
7.8-7.9 (day 0)
Dissolved oxygen:
9.0 (day 0)
Salinity:
Not applicable
Nominal and measured concentrations:
100 mg/L nominal (measured concentrations were 101-104% of nominal throughout the test period)
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 litre, all-glass vessels
- Type (delete if not applicable): No data
- Material, size, headspace, fill volume: 8 litres test solution
- Aeration: None initially, but introduced after 48 hr and lasted until the end of the test
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): No data
- 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: 0.3 g fish/L

TEST MEDIUM / WATER PARAMETERS
ISO-medium, aerated until the dissolved oxygen concentration had reached saturation and the pH had stabilised.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hrs daily
- Light intensity: No data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality at 3.75, 24, 48, 72 and 96 hr

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable (limit test at recommended 100 mg/L concentration)
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study: Yes
- Test concentrations: 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality was observed in any group in the range-finding study so a limit test was conducted in the final test.
Reference substance (positive control):
yes
Remarks:
pentachlorophenol
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: No mortaility of overt signs of toxicity seen
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: No mortaility of overt signs of toxicity seen
Details on results:
- Behavioural abnormalities: No data
- Observations on body length and weight: No data
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test material was completely soluble in medium.
- Effect concentrations exceeding solubility of substance in test medium: Not applicable
Results with reference substance (positive control):
- Results with reference substance valid? Yes, the sensitivity of carp in the reference test to PCP falls within the range of sensitivities generally observed in historical controls.
- Mortality: None at 0.10 mg/L, but complete mortality at 0.22 and 0.46 mg/L
- LC50: 0.15 mg/L (95% confidence limit = 0.10 - 0.22 mg/L) (96-hr LC50 but reached within 48 hr of exposure).
Reported statistics and error estimates:
Measured concentrations were stable and in agreement with nominal throughout the test period (101-104%).

Table 1: Incidence of mortality and total mortality during the limit test

 Concentration test substance (mg/L)     Initial number of fish     Cumulative mortality              Total mortality (%)
 3.75 hr  24 hr  48 hr  72 hr  96 hr  
 Blank-control  7  0  0  0  0  0  0
 100  7  0  0  0  0  0  0

Table 2: pH values and dissolved oxygen concentrations (mg/L) during the limit test

   Concentration test substance (mg/L)      Day 0     Day 1     Day 2     Day 3     Day 4   
 pH  O2  pH O2   pH  O2  pH  O2  pH  O2
 Blank-control  7.9  9.0  7.4  7.6  7.5  5.9  7.6  9.4  7.6  8.7
 100  7.8  9.0  7.4  7.1  7.4  5.2  7.6  7.3  7.7  8.2

Aeration was introduced after 48 hr as the oxygen concentration tended to drop below the recommended level (60% of air saturation).

Table 3: Incidence of mortality observed in the reference study

 Concentration PCP(mg/L) nominal  Initial number of fish     Cumulative number of dead fish recorded at various time points after start of exposure              Total mortality (%)
 2.25 hr  24 hr  48 hr  72 hr  96 hr  
 0.10  5  0  0  0  0  0  0
 0.22  5  0  3  5  5  5  100
 0.46  5  0  5  5  5  5  100
Validity criteria fulfilled:
yes
Conclusions:
In an OECD guideline study, to GLP, platinum (2+) tetraammine diacetate induced no mortalities or overt signs of toxicity in a limit test at 100 mg/L. Therefore the 96-hr LC50 to freshwater carp was determined to be >100 mg/L (>46.95 mg Pt/L).
Executive summary:

The acute aquatic toxicity of platinum (2+) tetraammine diacetate to freshwater carp (Cyprinus carpio) was determined in a 96-hr static test conducted according to OECD guidelines and to GLP.

 

A limit test was performed to demonstrate that the test substance has no toxic effect on the test fish up to the nominal concentration of 100 mg/L. Thus, the only nominal concentration tested was100 mg/L, and a control. Test substance concentrations in excess of 100 mg/L were not tested (based on test guidelines).

 

The 96-hr NOEC (highest concentration tested without any toxic effect after the exposure period of 96 hr) was 100 mg/L. Therefore the 96-hr LC50 of platinum (2 +) tetraammine diacetate to carp was estimated to be >100 mg/L (>46.95 mg Pt/L).

Description of key information

In an OECD guideline study, to GLP, tetraammineplatinum(II) diacetate induced no mortalities or overt signs of toxicity in a limit test at 100 mg/L. Therefore the 96-hr LC50 to freshwater carp was determined to be >100 mg/L (>46.95 mg Pt/L) (Migchielsen, 2006a).

Key value for chemical safety assessment

Additional information

The acute aquatic toxicity of tetraammineplatinum(II) diacetate to freshwater carp (Cyprinus carpio) was determined in a 96-hr static test (Klimisch 1) conducted according to OECD guidelines and to GLP.

 

A limit test was performed to demonstrate that the test substance has no toxic effect on the test fish up to the nominal concentration of 100 mg/L. Thus, only the nominal concentration of 100 mg/L was tested, along with a control. Test substance concentrations in excess of 100 mg/L were not tested (based on test guidelines).

No toxic effects were observed after the 96-hr observation period. Thus, the only tested concentration (100 mg/L) was considered to be the study NOEC. The 96-hr LC50 of tetraammineplatinum(II) diacetate to carp could not be determined, but was >100 mg/L (>46.95 mg Pt/L) (Migchielsen, 2006a).