Tetraammineplatinum dinitrate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

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:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Duplicate samples for analysis were taken from all test concentrations and the blank control, where 10 mL were taken from the approximate centre of each test vessel at the start and at the end of the test. Prior to analysis, samples were stored at room temperature.
Additionally, 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.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: preparation of test solutions started with a stock solution of 100 mg test item/L. The test substance was completely dissolved in the test medium by careful mixing. The lower test concentrations were prepared by subsequent dilutions of the stock in test medium. 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 (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain/clone: Straus, 1820
- Source: in-house laboratory culture with a known history
- Further details of test species: at least third generation of species, obtained by acyclical parthenogenesis from a healthy stock, 2nd to 5th brood, showing no signs of stress, presence of males, ephippia or discoloured animals
- Age of parental stock: more than two weeks old
- Age of test organisms: less than 24 hours old
- Feeding during test: none

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20.7 - 21.1 °C

pH:

7.9 - 8.0

Dissolved oxygen:

8.6 - 8.9 mg/L

Nominal and measured concentrations:

Nominal concentrations: 10, 18, 32, 56 and 100 mg test item/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100-mL glass test vessels, containing 80 mL test solution
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium, composed by macro salts (CaCl2.2H2O 293.8 mg/L, MgSO4.7H2O 123.3 mg/L, NaHCO2 64.8 mg/L, KCl 5.8 mg/L) dissolved in tap water purified by reverse osmosis (Milli-RO, Millipore Corp.)
- Intervals of water quality measurement: pH and dissolved oxygen were measured at the beginning and at the end of the test for all concentrations and controls. The temperature of medium was continuously measured in a temperature control vessel from the start of the test.

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

EFFECT PARAMETERS MEASURED: immobility of daphnids was observed at 24 and 48 hours of exposure.

RANGE-FINDING STUDY
- Test concentrations: 0.1, 1.0, 10, 100 mg test item/L
- Results used to determine the conditions for the definitive study: after 48 hours of exposure all organisms exposed to 100 mg test item/L were immobilised. No daphnids were found to be immobilised at the lower concentrations tested. Hence, the expected 48-hour EC50 was between nominal concentrations of 10 and 100 mg test item/L.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

20 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 16 - 29 mg test item/L

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

9.75 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 7.8 - 14.14 mg Pt/L. Pt concentrations calculated based on % Pt in the test material.

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

4.88 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Remarks on result:

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

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

86 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 80 - 98 mg test item/L

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

41.93 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 39 - 47.8 mg Pt/L. Pt concentrations calculated based on % Pt in the test material.

Details on results:

- In the control, no organisms were found to be immobilised or trapped at the surface of water.

Results with reference substance (positive control):

The 48-hour EC50 of potassium dichromate to Daphnia magna was estimated to be 0.63 mg/L with 5 % immobilisation at 0.56 mg/L and 100 % immobilisation at 1.0 mg/L.

Reported statistics and error estimates:

The EC50 values at 24 and 48 hours of exposure were calculated using Probit analysis with the maximum likelihood estimation method (Finney DJ, 1971).

Table 1. Acute immobilisation of Daphnia magna after 24 and 48 hours of exposure to platinum(2 +) tetraammine diacetate

Nominal concentration (mg test item/L)	Replicate No.	No. of exposed organisms	Response at 24 h		Response at 48 h
			number	total %	number	total %
Blank control	1	5	0	0	0	0
	2	5	0		0
	3	5	0		0
	4	5	0		0
10	1	5	0	5	0	5
	2	5	1		1
	3	5	0		0
	4	5	0		0
18	1	5	1	5	0	25
	2	5	0		3
	3	5	0		2
	4	5	0		0
32	1	5	0	5	5	90
	2	5	0		5
	3	5	0		5
	4	5	1		3
56	1	5	0	0	5	100
	2	5	0		5
	3	5	0		5
	4	5	0		5
100	1	5	5	75	5	100
	2	5	3		5
	3	5	4		5
	4	5	3		5

Validity criteria fulfilled:

yes

Conclusions:

Based on nominal concentrations, the 48-hour EC50 of platinum(2+) tetraammine diacetate for Daphnia magna was determined to be 20 mg/L (9.75 mg Pt/L). The NOEC was determined to be 10 mg test item/L (4.88 mg Pt/L).

Executive summary:

An acute Daphnia magna study was conducted with platinum(2+) tetrammine diacetate. The study is reliable without restrictions, being GLP-compliant and having followed standard test guidelines (OECD 202, ISO 6341 and EU Method C.2).

A static test system was followed. Based on a range-finding test, five test concentrations were used, and these were analysed using ICP-MS. A blank control and a positive control were also tested. Measured concentrations were found to be in agreement with nominal ones, and ranged from 86 to 97 % of nominal. Therefore, nominal concentrations were used for reporting of results. All validity criteria were met and no protocol deviations were recorded. The 48-hour EC50 of platinum(2+) tetraammine diacetate for Daphnia magna was determined to be 20 mg/L (9.75 mg Pt/L). The NOEC was determined to be 10 mg test item/L (4.88 mg Pt/L).

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH

The general principles applied for read across between metal substances are that ecotoxicity and the potential for adverse environmental effects are based on the metal ion in cases where the counter ions can reasonably be expected to be non-toxic, as is the case for many simple metals salts (e.g. anions such as SO42-, NO3-, OH-, see additional discussion below for Cl- compounds).

When reading across between different metal substances, the oxidation state of the metal ion needs to be carefully considered. For metals, chemical speciation can affect both the fate of the substance in the environment and its toxicity. For some metals (e.g. chromium and arsenic), large differences in environmental toxicity between difference oxidation states have been observed. For platinum substances, the database of ecotoxicity data is not as extensive as for other metal substances, but there may be a difference in toxicity between platinum (II) and platinum (IV) substances.

2. SOURCE AND TARGET CHEMICAL(S)

Source chemical: Platinum(2+) tetraammine diacetate
Target chemical: Tetraammineplatinum dinitrate

3. ANALOGUE APPROACH JUSTIFICATION

For platinum substances, the database of ecotoxicity data is not as extensive as for other metal substances, but there may be a difference in toxicity between platinum (II) and platinum (IV) substances. For this reason, read-across between different substances is limited to metal compounds in which the metal exists in the same oxidation state.

Generally, the strategies applied for read across between metal substances follow the principle that ecotoxicity and the potential for adverse environmental effects are based on the metal ion in cases where the counter ions can reasonably be expected to be non-toxic. There is some indication that for platinum (IV) substances, substances containing a chloro ligand are more toxic than those without a chloro ligand. As there is some evidence that platinum substances with a chloro ligand are more toxic, and this trend has been more clearly shown for other precious metal substances, read across for platinum (II) substances without a chloro ligand is only conducted from other platinum (II) substances without a chloro ligand.

Data for platinum(2+) tetraammine diacetate is therefore read across to tetraammineplatinum dinitrate, as both are platinum (II) substances that do not contain a chloro ligand.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

20 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 16 - 29 mg test item/L

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

9.75 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 7.8 - 14.14 mg Pt/L. Pt concentrations calculated based on % Pt in the test material.

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

4.88 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Remarks on result:

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

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

86 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 80 - 98 mg test item/L

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

41.93 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence Interval: 39 - 47.8 mg Pt/L. Pt concentrations calculated based on % Pt in the test material.

Validity criteria fulfilled:

yes

Conclusions:

Based on nominal concentrations, the 48-hour EC50 of platinum(2+) tetraammine diacetate for Daphnia magna was determined to be 20 mg/L (9.75 mg Pt/L). The NOEC was determined to be 10 mg test item/L (4.88 mg Pt/L).

Executive summary:

An acute Daphnia magna study was conducted with platinum(2+) tetrammine diacetate. The study is reliable without restrictions, being GLP-compliant and having followed standard test guidelines (OECD 202, ISO 6341 and EU Method C.2).

A static test system was followed. Based on a range-finding test, five test concentrations were used, and these were analysed using ICP-MS. A blank control and a positive control were also tested. Measured concentrations were found to be in agreement with nominal ones, and ranged from 86 to 97 % of nominal. Therefore, nominal concentrations were used for reporting of results. All validity criteria were met and no protocol deviations were recorded. The 48-hour EC50 of platinum(2+) tetraammine diacetate for Daphnia magna was determined to be 20 mg/L (9.75 mg Pt/L). The NOEC was determined to be 10 mg test item/L (4.88 mg Pt/L).

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance was introduced into the dilution water whilst stirring by the aid of a magnetic stirrer for 2 hours. The maximum concentration applied was 10 g/L
- Controls: dilution water without the test item
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): not reported

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain/clone: STRAUS
- Source: LWA Dusseldorf
- Age at study initiation: < 24 hours
- Feeding during test: none

ACCLIMATION
- Acclimation period: 48 hours
- Acclimation conditions (same as test or not): not reported
- Type and amount of food: not reported
- Health during acclimation (any mortality observed): not reported

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20.5 °C

pH:

7.53 - 8.07

Dissolved oxygen:

8.3 - 8.7 mg/L

Nominal and measured concentrations:

Nominal concentrations: 5, 10, 20, 40, 80 and 160 mg test item/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass vessels
- Type: covered with a paper sheet
- Fill volume: 10 mL
- Aeration: not reported
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: the dilution water was prepared from four stock solutions, respectively dissolved in 1 L of deionized water: a) 0.22 g KCl, b) 2.52 g NaHCO3, c) 11.76 g CaCl2 * 2 H20, d) 4.93 MgSO4 * 7 H2O. Then, 25 mL of each solution were added to 900 mL deionized water and stirred vigorously for about 30 minutes.
- Oxygen content: 8.6 mg/L

OTHER TEST CONDITIONS
Photoperiod: 16 hours light and 8 hours darkness

EFFECT PARAMETERS MEASURED: the swimming behaviour of organisms was determined every 24 hours. To this end, test vessels were gently agitated, and daphnids showing no swimming within 15 seconds were considered as immobile. Moving of antenna was not considered as swimming.

RANGE-FINDING STUDY
- Test concentrations: 10, 100, 1000 and 10000 mg tes item/L
- Results used to determine the conditions for the definitive study: results showed 100% immobilisation of organisms exposed to 100, 1000 and 10000 mg test item/L after 48 hours.

Reference substance (positive control):

yes

Remarks:

Potassium-dichromate

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

5.06 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

28 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

14.18 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

80 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

40.51 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Details on results:

The 48-hour EC50 value was calculated as the geometric mean of all values between EC0 and EC100. EC0 and EC100 were taken directly from the concentrations being tested.

Results with reference substance (positive control):

The sensitivity of the test system towards toxic substances was tested once a month using potassium-dichromate against daphnids of the same laboratory bred as used in the present test. The EC50 of potassium-dichromate was determined to be 1.2 mg/L.

Reported statistics and error estimates:

The concentrations of the test item and the respective % of immobilisation were plotted on a probit-paper in order to determine the EC50 value.

Table 1. Screening test results: No. of immobilised Daphnia magna organisms after exposure to tetraammineplatinum (2 +) hydrogencarbonate

Nominal concentration (mg test item/L)	Immobilised organisms (%)
	after 24 hours	after 48 hours
control	0	0
10	0	20
100	50	100
1000	100	100
10000	100	100

 

Table 2. Percentage of Immobilised Daphnia magna organisms after 24 and 48 hours of exposure to tetraammineplatinum (2 +) hydrogencarbonate

	Ratio immobilised organisms (%)
Nominal test concentration (mg test item/L)	24 h	48 h
Control	0	0
5	0	0
10	0	0
20	0	25
40	5	70
80	10	100
160	45	100

Validity criteria fulfilled:

yes

Conclusions:

Based on nominal concentrations, the 48-hour EC50 of tetrammineplatinum (2+) hydrogencarbonate was determined to be 28 mg test item/L (14.18 mg Pt/L).

Executive summary:

A 48 -h acute Daphnia magna study was conducted for tetraammineplatinum(2+) hydrogencarbonate. The study is reliable with restrictions, being GLP-compliant and having followed a standard test guideline (OECD 202), but with some limitations in design and reporting.

A static test system was followed. Six test concentrations were used, and the swimming behaviour of the organisms was recorded. All validity criteria were met. The 48-hour EC50 was observed to be 28 mg test item/L (14.18 mg Pt/L), and it was calculated as the geometric mean of all values between EC0 and EC100.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH

The general principles applied for read across between metal substances are that ecotoxicity and the potential for adverse environmental effects are based on the metal ion in cases where the counter ions can reasonably be expected to be non-toxic, as is the case for many simple metals salts (e.g. anions such as SO42-, NO3-, OH-, see additional discussion below for Cl- compounds).

When reading across between different metal substances, the oxidation state of the metal ion needs to be carefully considered. For metals, chemical speciation can affect both the fate of the substance in the environment and its toxicity. For some metals (e.g. chromium and arsenic), large differences in environmental toxicity between difference oxidation states have been observed. For platinum substances, the database of ecotoxicity data is not as extensive as for other metal substances, but there may be a difference in toxicity between platinum (II) and platinum (IV) substances.

2. SOURCE AND TARGET CHEMICAL(S)

Source chemical: Tetraammineplatinum(2+) hydrogencarbonate
Target chemical: Tetraammineplatinum dinitrate

3. ANALOGUE APPROACH JUSTIFICATION

For platinum substances, the database of ecotoxicity data is not as extensive as for other metal substances, but there may be a difference in toxicity between platinum (II) and platinum (IV) substances. For this reason, read-across between different substances is limited to metal compounds in which the metal exists in the same oxidation state.

Generally, the strategies applied for read across between metal substances follow the principle that ecotoxicity and the potential for adverse environmental effects are based on the metal ion in cases where the counter ions can reasonably be expected to be non-toxic. There is some indication that for platinum (IV) substances, substances containing a chloro ligand are more toxic than those without a chloro ligand. As there is some evidence that platinum substances with a chloro ligand are more toxic, and this trend has been more clearly shown for other precious metal substances, read across for platinum (II) substances without a chloro ligand is only conducted from other platinum (II) substances without a chloro ligand.

Data for tetraammine platinum hydrogen carbonate is therefore read across to tetraammineplatinum dinitrate, as both are platinum (II) substances that do not contain a chloro ligand.

Reason / purpose for cross-reference:

read-across source

Reference substance (positive control):

yes

Remarks:

Potassium-dichromate

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

5.06 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

28 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

14.18 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

80 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

40.51 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Pt

Basis for effect:

mobility

Details on results:

The 48-hour EC50 value was calculated as the geometric mean of all values between EC0 and EC100. EC0 and EC100 were taken directly from the concentrations being tested.

Results with reference substance (positive control):

The sensitivity of the test system towards toxic substances was tested once a month using potassium-dichromate against daphnids of the same laboratory bred as used in the present test. The EC50 of potassium-dichromate was determined to be 1.2 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

Based on nominal concentrations, the 48-hour EC50 of tetrammineplatinum (2+) hydrogencarbonate was determined to be 28 mg test item/L (14.18 mg Pt/L).

Executive summary:

A 48 -h acute Daphnia magna study was conducted for tetraammineplatinum(2+) hydrogencarbonate. The study is reliable with restrictions, being GLP-compliant and having followed a standard test guideline (OECD 202), but with some limitations in design and reporting.

A static test system was followed. Six test concentrations were used, and the swimming behaviour of the organisms was recorded. All validity criteria were met. The 48-hour EC50 was observed to be 28 mg test item/L (14.18 mg Pt/L), and it was calculated as the geometric mean of all values between EC0 and EC100.

Reference 5

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:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

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.

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 (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

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

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

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

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

Key result

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

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

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

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

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

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).

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

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 (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 (7.6 mg Pt/L). The 48-hour NOEC was determined to be 10 mg test item/L (5.06 mg Pt/L).

Reference 6

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH

The general principles applied for read across between metal substances are that ecotoxicity and the potential for adverse environmental effects are based on the metal ion in cases where the counter ions can reasonably be expected to be non-toxic, as is the case for many simple metals salts (e.g. anions such as SO42-, NO3-, OH-, see additional discussion below for Cl- compounds).

When reading across between different metal substances, the oxidation state of the metal ion needs to be carefully considered. For metals, chemical speciation can affect both the fate of the substance in the environment and its toxicity. For some metals (e.g. chromium and arsenic), large differences in environmental toxicity between difference oxidation states have been observed. For platinum substances, the database of ecotoxicity data is not as extensive as for other metal substances, but there may be a difference in toxicity between platinum (II) and platinum (IV) substances.

2. SOURCE AND TARGET CHEMICAL(S)

Source chemical: Tetraammineplatinum(2+) hydrogencarbonate
Target chemical: Tetraammineplatinum dinitrate

3. ANALOGUE APPROACH JUSTIFICATION

For platinum substances, the database of ecotoxicity data is not as extensive as for other metal substances, but there may be a difference in toxicity between platinum (II) and platinum (IV) substances. For this reason, read-across between different substances is limited to metal compounds in which the metal exists in the same oxidation state.

Generally, the strategies applied for read across between metal substances follow the principle that ecotoxicity and the potential for adverse environmental effects are based on the metal ion in cases where the counter ions can reasonably be expected to be non-toxic. There is some indication that for platinum (IV) substances, substances containing a chloro ligand are more toxic than those without a chloro ligand. As there is some evidence that platinum substances with a chloro ligand are more toxic, and this trend has been more clearly shown for other precious metal substances, read across for platinum (II) substances without a chloro ligand is only conducted from other platinum (II) substances without a chloro ligand.

Data for tetraammine platinum hydrogen carbonate is therefore read across to tetraammineplatinum dinitrate, as both are platinum (II) substances that do not contain a chloro ligand.

Reason / purpose for cross-reference:

read-across source

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

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

Key result

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

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

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

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

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

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

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 (76 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 (7.6 mg Pt/L). The 48-hour NOEC was determined to be 10 mg test item/L (5.06 mg Pt/L).

Description of key information

For tetraammine platinum dinitrate, ecotoxicity data are read across from other Pt(II) substances without a chloro ligand, tetraammine platinum hydrogen carbonate and platinum(2+) tetraammine diacetate.

The lowest EC50 value is a 48-hour EC50 of 7.6 mg Pt L^-1.

Additional information

For tetraammine platinum dinitrate, ecotoxicity data are read across from other Pt(II) substances without a chloro ligand, tetraammine platinum hydrogen carbonate and platinum(2+) tetraammine diacetate.

A 48-h acute Daphnia magna study is available for tetraammineplatinum(2+) hydrogencarbonate following OECD guideline 202 (Lebertz 1997). A static test system was followed. Six test concentrations were used, and the swimming behaviour of the organisms was recorded. All validity criteria were met. The 48-hour EC50 was observed to be 28 mg test item L-1 (14.18 mg Pt L-1), and it was calculated as the geometric mean of all values between EC0 and EC100.

A second 48-h acute immobilisation Daphnia magna study is also available for tetraammineplatinum(2+) hydrogencarbonate following OECD guideline 202 and EU Method C.2 (Wetton and Bartlett 1997). 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 close to nominal with the exception of the lowest test concentration, where measured values were 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-1, results were based on nominal test item concentrations. The 48-hour EC50 was estimated to be 15 mg test item L-1 (7.6 mg Pt L-1). The 48-hour NOEC was determined to be 10 mg test item L-1 (5.06 mg Pt L-1).

An acute Daphnia magna study is available for platinum(2+) tetraammine diacetate following OECD Guideline 202, ISO 6341 and EU Method C.2 (Migchielsen 2005). A static test system was followed. Based on a range-finding test, 5 test concentrations were used, and these were analysed using ICP-MS. A blank control and a positive control were also tested. Measured concentrations were found to be in agreement with nominal ones, and ranged from 86 to 97 % of nominal. Therefore, nominal concentrations were used for reporting of results. All validity criteria were met and no protocol deviations were recorded. The 48-hour EC50 was determined to be 20 mg L^-1 (9.75 mg Pt L^-1). The NOEC was determined to be 10 mg test item L^-1 (4.88 mg Pt L^-1).