Tetraammineplatinum dichloride

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:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Test guideline 3

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Platinum(2+) tetraammine diacetate

Cas Number:

0127733-97-5

IUPAC Name:

Platinum(2+) tetraammine diacetate

Test material form:

solid

Remarks:

crystalline powder

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

10-mL samples were taken in duplicate from the test concentration and the blank control at the beginning and at the end of the test. Prior to analysis, samples were stored at room temperature.
In addition, singular reserve samples of 10 mL were taken for possible analysis. If not used, these samples were stored at room temperature for a maximum of three months.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: preparation of test solutions started with a solution of 100 mg test item/L. The test substance was completely dissolved in test medium by careful mixing. The final test solutions were all clear and colourless.
- Controls: test medium without test substance or other additives (blank control)
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: carp
- Strain: Linnaeus, 1758
- Source: Zodiac, proefacc, 'De Haar Vissen', Wageningen University and Research Centre, The Netherlands
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): mean length of 2.3 ± 0.3 cm (n = 10)
- Weight at study initiation (mean and range, SD): mean weight of 0.38 ± 0.11 g (n = 10)
- Method of breeding: F1 from a single parent-pair bred in UV-treated water

ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions (same as test or not): ISO-medium formulated using tap water purified by reverse osmosis
- Type and amount of food during acclimation: pelleted fish food and/or artemia, daily until 24 hours before start of test
- Health during acclimation (any mortality observed): mortality was less than 5 % during the 7 days prior to the start of the test

FEEDING DURING TEST: none

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

250 mg/L as CaCO3

Test temperature:

21.0 - 22.9 °C

pH:

7.4 - 7.9

Dissolved oxygen:

5.2 - 9.4 mg/L

Nominal and measured concentrations:

Nominal concentration: 100 mg test item/L (the only concentration tested)

Details on test conditions:

TEST SYSTEM
- Test vessel: 10-L glass vessels, containing 8 L of test solution
- Aeration: aeration was introduced after 48 hours of exposure and lasted until the end of the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.3 g fish/L, i.e. 7 fish per 8 L of test medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO-medium, formulated using tap water purified by reverse osmosis and composed by CaCl2.2H20 293.8 mg/L, MgSO4.7H20 123.8 mg/L, NaHCO3 64.8 mg/L, KCl 5.8 mg/L. The ISO-medium was aerated until the dissolved oxygen concentration reached saturation and the pH was stabilised.
- Total Hardness: 250 mg CaCO3/L
- Intervals of water quality measurement: pH, nitrate, nitrite and ammonia concentrations were measured once a week. Dissolved oxygen content, pH and temperature were measured every day.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours of light, daily
- Light intensity: not reported

EFFECT PARAMETERS MEASURED: mortality and any adverse effect were recorded at 3.15, 24, 48, 72 and 96 hours of exposure. In addition, every afternoon from day 0 and every morning from day 1, observation of any dead or severely distressed fish was made.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1.0, 10, 100 mg test item/L
- Results used to determine the conditions for the definitive study: no mortality or clinical effects were observed at any of the test concentrations throughout the test. Therefore, the expected LC50 was above 100 mg test item/L.

Reference substance (positive control):

yes

Remarks:

pentachlorophenol

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 46.95 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mortality (fish)

Remarks on result:

other: Pt concentrations calculated based on % Pt in the test material.

Effect concentrations 3

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

46.95 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mortality (fish)

Remarks on result:

other: Pt concentrations calculated based on % Pt in the test material.

Details on results:

No mortality or clinical effect were observed at any of the test concentration throughout the test period.

Results with reference substance (positive control):

A 96-hour acute toxicity study in the carp with pentachlorophenol (PCP) determined a 96-h LC50 of 0.15 mg/L (95% Confidence Interval of 0.10 - 0.22 mg/L), which was already reached at 48 hours.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1. Incidence of mortality and total mortality at 3.15, 24, 48, 72 and 96 hours of exposure to platinum(2 +) tetraammine diacetate for Cyprinus carpio

Nominal concentration (mg test item/L)	Initial No. of fish	Cumulative mortality					Total mortality (%)
		3.15 hours	24 hours	48 hours	72 hours	96 hours
Blank control	7	0	0	0	0	0	0
100	7	0	0	0	0	0	0

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on single nominal concentration, the 96-hour LC50 of platinum(2+) tetraammine diacetate for Cyprinus carpio was determined to be >100 mg test item/L corresponding to >46.95 mg Pt/L. The 96-hour NOEC was determined to be 100 mg test item/L (46.95 mg Pt/L).

Executive summary:

An acute study was performed with Cyprinus carpio for platinum(2+) tetraammine diacetate. The study is reliable without restrictions, being GLP-compliant and having followed standard test guidelines (OECD 203, EU Method C.1 and ISO 7346 -1 Part 1).

A static test procedure was followed. Based on a range-finding study, a limit test was conducted at a nominal test concentration of 100 mg/L, and this was analysed using ICP-MS. Measured test concentrations were found to be stable throughout the test and ranged from 101 % to 104 % of nominal. All validity criteria were met and no protocol deviations were recorded. Based on the limit test, the 96-hour LC50 of platinum(2+) tetraammine diacetate for Cyprinus carpio was determined to be > 100 mg test item/L corresponding to >46.95 mg Pt/L. The 96-hour NOEC was determined to be 100 mg test item/L (46.95 mg Pt/L).