tetraammine platinum (II) hydrogen carbonate

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:

other: GLP compliant, guideline study, available as unpublished report, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

123439-82-7

Cas Number:

123439-82-7

IUPAC Name:

123439-82-7

Constituent 2

Reference substance name:

Tetrammine platinum (II) hydrogen carbonate

IUPAC Name:

Tetrammine platinum (II) hydrogen carbonate

Test material form:

solid

Remarks:

powder

Details on test material:

- Description: white powder

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Sampling was conducted on old and new media. Water samples were taken form the control and each replicate test vessel at 0, 24 and 96 hours for quantitative analysis.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: an amount of test material (4.00 g) was dispersed in reverse osmosis water with the aid of ultrasonication and the volume was adjusted to 1 L to give a 4.00 g/L stock solution. An aliquot of 500 mL of this stock solution was dispersed in dechlorinated tap water and the volume was adjusted to 20 L in order to give the 100 mg/L test concentration.
- Control: dechlorinated tap water without the test item

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Parkwood Trout Farm, Harrietsham, Kent, UK
- Age at study initiation: juvenilesrainbow trout
- Length at study initiation (mean and SD): 4.8 cm (SD=0.4)
- Weight at study initiation (mean and SD): 1.47 cm (SD=0.39)
- Feeding during test: no feeding during test or 24 hours prior to the test

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: commercial trout pellets
- Health during acclimation (any mortality observed): zero mortality

Fish were maintained in-house since 14 October 1996 in a glass fibre tank with "single pass" water renewal system. Fish were acclimatised to test conditions for 7 days prior to test and the lighting cycle was controlled to give a 16 hours of light and 8 hours dark.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

100 mg/l as CaCO3

Test temperature:

13 - 14 °C

pH:

7.5 - 8.1

Dissolved oxygen:

8.7 - 9.4 mg/L

Nominal and measured concentrations:

Nominal concentrations: 100 mg test item/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass vessels (covered)
- Material, size, headspace, fill volume: 20 L
- Aeration: areation was done via narrow bore glass tubes.
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.74 g body weight/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water dechlorinated by passage through an activated carbon filter
- Total Hardness: 100 mg/L as CaCO3
- Metals (mean values): calcium 81 mg/L, magnesium 14 mg/L, sodium 56 mg/L, potassium 4.4 mg/L, iron 58 mg/L, manganese < 6 μg/L, aluminum < 20 μg/L, copper 10 μg/L, zinc 20 μg/L, lead < 7 μg/L, cadmium < 0.5 μg/L, silver < 0.2 μg/L, boron 100 μg/L, barium 80 μg/L, arsenic < 1 μg/L, chromium < 5 μg/L, nickel 5 μg/L
- Alkalinity: 137 mg/L (mean)
- Conductivity: 627 μS/cm (mean)

OTHER TEST CONDITIONS
- Photoperiod: 16 light : 8 dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Any mortalities abd sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of the exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation.

TEST CONCENTRATIONS
A range-range finiding study was initially performed at 1, 10 and 100 mg/L test concentrations.
A limit test was conducted after the range finding test and it consisted of a test concentration of 100 mg/L.

Reference substance (positive control):

no

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.:

> 50.64 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mortality (fish)

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.:

>= 50.64 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mortality (fish)

Effect concentrations 5

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: sub-lethal effects

Effect concentrations 6

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 50.64 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

other: sub-lethal effects

Details on results:

- Behavioural abnormalities: none
- Mortality of control: zero mortality
- The NOEC was based upon zero mortalities and the absence of any sub-lethal effects of exposure at 100 mg test item/L

Reported statistics and error estimates:

An estimate of the LC50 and NOEC values was given by inspection of the mortality data.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1. Cumulative mortality data at 3, 6, 24, 48, 72 and 96 hours of exposure to the test item for Oncorhyncus mykiss

Nominal concentration (mg/L)	Cumulative mortality (Initial population - 10)						% mortality
	3 hours	6 hours	24 hours	48 hours	72 hours	96 hours	96 hours
Control	0	0	0	0	0	0	0
100 (Replicate 1)	0	0	0	0	0	0	0
100 (Replicate 2)	0	0	0	0	0	0	0

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on nominal concentrations, the 96-hour LC50 of tetraammineplatinum(2+) hydrogencarbonate to rainbow trout was greater than 100 mg test item/L corresponding to >50.64 mg Pt/L. Correspondingly the NOEC was greater than or equal to 100 mg test item /L (≥ 50.64 mg Pt/L).

Executive summary:

An acute Oncorhyncus mykiss study is available for tetraammineplatinum(2+) hydrogencarbonate. The study is reliable without restrictions, being GLP-compliant and having followed standard test guidelines (OECD 203 and EU Method C.1).

A semi-static test procedure was followed, and test solutions were renewed every 24 hours. Based on the range-finding study, a limit test was conducted at a nominal test concentration of 100 mg test item/L, and this was analysed using HPLC. Measured test concentrations ranged from 96 % to 101 % of nominal, and therefore results were based on nominal concentrations. The 96-hour LC50 was determined to be >100 mg test item/L corresponding to >50.64 mg Pt/L. The 96-hour NOEC was determined to be ≥ 100 mg test item/L (≥ 50.64 mg Pt/L).