tetraammine platinum (II) hydrogen carbonate

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

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other: GLP-compliant, guideline study, available as unpublished report, fully adequate for assessment.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 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

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:

The concentration and stability of the test material in the test solutions were verified by chemical analysis at 0 and 48 hours.

Test solutions

Vehicle:

no

Details on test solutions:

An amount of test material (200 mg) was dispersed in reconstituted water with the aid of ultrasonication and the volume was adjusted to 2 L to give the 100 mg/L test concentration. Dilutions were then made to give the remaining test concentrations: 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 mg test item/L.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: Daphnia magna were mantained in a laboratory culture originating from a strain supplied by the Institut National de Recherche Chimique Appliquee (IRCHA), France
- Age at study initiation: first instar
- Method of breeding: Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated 24 hours prior to the initiation of the test, the young daphnids produced overnight were then removed for testing.
- Feeding during test: none

ACCLIMATION
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: suspension of mixed algae (predominantly Chlorella ssp.)
- Feeding frequency: daily
- Health during acclimation (any mortality observed): none

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

270 mg/L as CaCO3

Test temperature:

21 °C

pH:

8.0 - 8.1

Dissolved oxygen:

7.7 - 8.2 mg/l

Nominal and measured concentrations:

Nominal concentrations: 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg test item/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL glass jars, containing 200 mL test solution
- Type: closed
- Aeration: No areation
- Renewal rate of test solution (frequency/flow rate): none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water, prepared from four stock solutions: a) CaCl2.2H2O 11.76 g/L, b) MgSO4.7H2O 4.93 g/L, c) NaHCO3 2.59 g/L, d) KCl 0.23 g/L. Twenty-five mL of each stock solution a-d were added to each L (final volume) of deionised water. The pH was equal to 7.8 ± 0.2, and adjusted (if necessary) with NaOH or HCl. The reconstituted water was aerated until the dissolved oxygen concentration was approximately air-saturation value.
- Conductivity: < 5 μS/cm
- Total Hardness: 270 mg/L as CaCO3

OTHER TEST CONDITIONS
- Photoperiod: 16 hours of light and 8 hours of dark

EFFECT PARAMETERS MEASURED: any immobilisation or adverse reactions to exposure were recorded at 24 and 48 hours. Daphnids were considered to be immobilised if they were unable to swim for approximately 15 seconds after gentle agitation.

TEST CONCENTRATIONS
A range-finding study was initially performed at 0.1, 1, 10 and 100 mg/L test concentrations. The results showed no immobilisation at the test concentrations of 0.1, 1 and 10 mg test item/L. However, immobilisation was observed at 100 mg test item/L. Based on this information test concentrations of 1, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg test item/L were selected for the definitive study.

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

52 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 46 - 59 mg test item/L

Effect concentrations 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

26.33 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 23.3 - 29.9 mg Pt/L

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

15 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 14 - 17 mg test item/L

Effect concentrations 4

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

7.6 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 7.09 - 8.61 mg Pt/L

Effect concentrations 5

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 6

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

16.2 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Effect concentrations 7

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 8

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

5.06 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Reported statistics and error estimates:

Immobilisation data was evaluated using the moving average method of Thompson (1947).

Any other information on results incl. tables

Table 1. Cumulative immobilisation data at 24 and 48 hours of exposure of tetrammineplatinum (2 +) hydrogen carbonate to Daphnia magna.

Nominal concentration (mg test item/L)	Cumulative immobilised Daphnia (Initial population: 10 per replicate)
	24 hours				48 hours
	Replicate 1	Replicate 2	Total	%	Replicate 1	Replicate 2	Total	%
Control	0	0	0	0	0	0	0	0
1.0	0	0	0	0	0	0	0	0
1.8	0	0	0	0	0	0	0	0
3.2	0	0	0	0	0	0	0	0
5.60	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0
18	0	0	0	0	8	7	15	75
32	0	0	0	0	10	10	20	100
56	7	6	13	65	10	10	20	100
100	10	10	20	100	10	10	20	100

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on nominal concentrations, the 48-hour EC50 of tetraammineplatinum (2+) hydrogen carbonate to Daphnia magna was determined to be 15 mg test item/L corresponding to 7.6 mg Pt/L).

Executive summary:

A 48-h acute immobilisation Daphnia magna study is available for tetraammineplatinum(2+) hydrogencarbonate. The study is reliable without restrictions, being GLP-compliant, and having followed standard test guidelines (OECD 202 and EU Method C.2).

A static test system was followed. Based on a range-finding test, 9 test concentrations were used, and these were analysed using HPLC. Measured test concentrations were closer to nominal with the exception of the lowest test concentration, whose measured values were of 144 % and 194 % of nominal at 0 and 48 hours, respectively. Since this test group was below the estimated NOEC of 10 mg test item/L, results were based on nominal test item concentrations. The 48-hour EC50 was estimated to be 15 mg test item/L corresponding to 7.6 mg Pt/L. The 48-hour NOEC was determined to be 10 mg test item/L (5.06 mg Pt/L).