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Diss Factsheets

Administrative data

Endpoint:
biodegradation in soil: simulation testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
transformation / dissolution of metals and inorganic metal compounds
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14-07-2017 to 11-09-2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Series on Testing and Assessment No. 29 (23-Jul-2001): Guidance document on transformation/dissolution of metals and metal compounds in aqueous media
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 97.1 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate
Loading of aqueous phase:
100 other: mg/L of test item
Incubation duration:
2 h
Test conditions:
- Reconstituted standard based on ISO 6341;
- The aqueous medium solution sterilized by filtration (0.2 µm)
- pH=7;
- 20 +/- 1 °C;
- dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 97.7 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate
Loading of aqueous phase:
100 other: mg/L of test item
Incubation duration:
6 h
Test conditions:
- Reconstituted standard based on ISO 6341;
- The aqueous medium solution sterilized by filtration (0.2 µm)
- pH=7;
- 20 +/- 1 °C;
- dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 97.5 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate
Loading of aqueous phase:
100 other: mg/L of test item
Incubation duration:
12 h
Test conditions:
- Reconstituted standard based on ISO 6341;
- The aqueous medium solution sterilized by filtration (0.2 µm)
- pH=7;
- 20 +/- 1 °C;
- dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 97.7 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate
Loading of aqueous phase:
100 other: mg/L of test item
Incubation duration:
24 h
Test conditions:
- Reconstituted standard based on ISO 6341;
- The aqueous medium solution sterilized by filtration (0.2 µm)
- pH=7;
- 20 +/- 1 °C;
- dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 96.9 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate
Loading of aqueous phase:
100 other: mg/L of test item
Incubation duration:
72 h
Test conditions:
- Reconstituted standard based on ISO 6341;
- The aqueous medium solution sterilized by filtration (0.2 µm)
- pH=7;
- 20 +/- 1 °C;
- dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 98.6 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate
Loading of aqueous phase:
100 other: mg/L of test item
Incubation duration:
168 h
Test conditions:
- Reconstituted standard based on ISO 6341;
- The aqueous medium solution sterilized by filtration (0.2 µm)
- pH=7;
- 20 +/- 1 °C;
- dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 54.1 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate; Calcium
Loading of aqueous phase:
10 g/L
Incubation duration:
0 h
Test conditions:
- Purified water adjusted to pH 2;
- 37 +/- 1°C;
- Dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 98.1 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate; Calcium
Loading of aqueous phase:
10 g/L
Incubation duration:
0.5 h
Test conditions:
- Purified water adjusted to pH 2;
- 37 +/- 1°C;
- Dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 99.3 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate; Calcium
Loading of aqueous phase:
10 g/L
Incubation duration:
2 h
Test conditions:
- Purified water adjusted to pH 2;
- 37 +/- 1°C;
- Dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 97.8 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate; Calcium
Loading of aqueous phase:
10 g/L
Incubation duration:
4 h
Test conditions:
- Purified water adjusted to pH 2;
- 37 +/- 1°C;
- Dark conditions.
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
ca. 97.5 other: Total recovery (%)
Element analysed:
Sodium; Potassium; Sulphate; Calcium
Loading of aqueous phase:
10 g/L
Incubation duration:
6 h
Test conditions:
- Purified water adjusted to pH 2;
- 37 +/- 1°C;
- Dark conditions.

2-RESULTS

2.1-TRANSFORMATION/DISSOLUTION AT PH 7

2.1.1-ION CHROMATOGRAPHY

The mean concentrations (mg/L, corrected for matrix blank), concentration per unit mass (mg/kg) and as a percentage recovery for the sodium, potassium and sulphate analyses are shown in the following tables

Sodium

Sample

Meanconcentration

(mg/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 2hr

6.9337

68043.8

6.80

SPL 2 2hr

7.1597

65624.8

6.56

SPL 3 2hr

6.6097

67791.5

6.78

SPL 1 6hr

7.3312

71944.7

7.19

SPL 2 6hr

7.6312

69946.5

7.00

SPL 3 6hr

6.5822

67509.4

6.75

SPL 1 12hr

7.2342

70992.8

7.10

SPL 2 12hr

7.2722

66656.0

6.67

SPL 3 12hr

6.5552

67232.5

6.72

SPL 1 24hr

7.2432

71081.1

7.11

SPL 2 24hr

7.6817

70409.4

7.04

SPL 3 24hr

6.9537

71319.7

7.13

SPL 1 72hr

6.8797

67513.9

6.75

SPL 2 72hr

6.5607

60134.4

6.01

SPL 3 72hr

6.1462

63037.6

6.30

SPL 1 168hr

7.6570

75142.0

7.51

SPL 2 168hr

6.8207

62517.6

6.25

SPL 3 168hr

6.6382

68083.8

6.81

 

Potassium

Sample

Meanconcentration

(mg/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 2hr

33.8808

332491

33.25

SPL 2 2hr

35.8413

328518

32.85

SPL 3 2hr

32.0138

328347

32.83

SPL 1 6hr

34.0973

334616

33.46

SPL 2 6hr

35.8568

328660

32.87

SPL 3 6hr

32.1033

329265

32.93

SPL 1 12hr

34.0898

334542

33.45

SPL 2 12hr

35.8863

328931

32.89

SPL 3 12hr

32.0808

329034

32.90

SPL 1 24hr

34.0133

333791

33.38

SPL 2 24hr

35.8743

328821

32.88

SPL 3 24hr

32.1443

329686

32.97

SPL 1 72hr

34.2493

336107

33.61

SPL 2 72hr

35.8843

328912

32.89

SPL 3 72hr

32.0253

328465

32.85

SPL 1 168hr

36.2023

355273

35.53

SPL 2 168hr

35.8283

328399

32.84

SPL 3 168hr

32.7953

336362

33.64

 

Sulphate

Sample

Meanconcentration

(mg/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 2hr

58.8786

577807

57.78

SPL 2 2hr

62.9819

577286

57.73

SPL 3 2hr

55.2756

566929

56.69

SPL 1 6hr

59.2475

581428

58.14

SPL 2 6hr

62.9803

577271

57.73

SPL 3 6hr

55.6540

570811

57.08

SPL 1 12hr

59.1072

580051

58.01

SPL 2 12hr

62.6056

573837

57.38

SPL 3 12hr

55.9918

574275

57.43

SPL 1 24hr

58.9411

578421

57.84

SPL 2 24hr

62.5150

573003

57.30

SPL 3 24hr

55.7930

572236

57.22

SPL 1 72hr

59.1190

580167

58.02

SPL 2 72hr

61.9963

568252

56.83

SPL 3 72hr

55.9563

573911

57.39

SPL 1 168hr

59.2752

581700

58.17

SPL 2 168hr

61.6852

565400

56.54

SPL 3 168hr

56.9305

583903

58.39

2.1.2-ICP-MS (confirmatory analysis)

From the analysis of the sample solutions, the counts per second for each analyte were interpolated from the respective calibrations to give the concentration of analyte (mg/L). The mean concentrations (mg/L), concentration per unit mass (mg/kg) and as a percentage recovery for the sodium, potassium and sulphate analyses are shown in the following tables:

Sodium

Sample

Meanconcentration

(mg/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 2hr

7.17

70345

7.03

SPL 2 2hr

8.59

78709

7.87

SPL 3 2hr

7.44

76328

7.63

SPL 1 6hr

8.24

80848

8.08

SPL 2 6hr

7.44

68186

6.82

SPL 3 6hr

7.41

75967

7.60

SPL 1 12hr

7.78

76379

7.64

SPL 2 12hr

7.65

70107

7.01

SPL 3 12hr

9.11

93424

9.34

SPL 1 24hr

8.36

82054

8.21

SPL 2 24hr

9.12

83582

8.36

SPL 3 24hr

8.47

86842

8.68

SPL 1 72hr

10.2

100362

10.0

SPL 2 72hr

8.87

81275

8.13

SPL 3 72hr

8.39

86031

8.60

SPL 1 168hr

10.1

99181

9.92

SPL 2 168hr

8.53

78216

7.82

SPL 3 168hr

8.08

82886

8.29

 

Potassium

Sample

Meanconcentration

(mg/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 2hr

37.2

364925

36.5

SPL 2 2hr

32.4

297010

29.7

SPL 3 2hr

30.8

315478

31.6

SPL 1 6hr

32.1

314940

31.5

SPL 2 6hr

34.1

312152

31.2

SPL 3 6hr

29.8

305441

30.5

SPL 1 12hr

31.7

310825

31.1

SPL 2 12hr

34.3

314660

31.5

SPL 3 12hr

30.3

310682

31.1

SPL 1 24hr

34.3

336110

33.6

SPL 2 24hr

35.3

324221

32.4

SPL 3 24hr

31.4

321639

32.2

SPL 1 72hr

34.6

339226

33.9

SPL 2 72hr

35.5

325232

32.5

SPL 3 72hr

32.5

333472

33.4

SPL 1 168hr

34.9

342158

34.2

SPL 2 168hr

34.8

318893

31.9

SPL 3 168hr

31.6

323864

32.4

 

Sulphate

Sample

Meanconcentration

(mg/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 2hr

52.0

509811

51.0

SPL 2 2hr

57.1

523100

52.3

SPL 3 2hr

52.2

535301

53.5

SPL 1 6hr

56.7

556379

55.6

SPL 2 6hr

61.3

561922

56.2

SPL 3 6hr

46.0

471789

47.2

SPL 1 12hr

50.4

495081

49.5

SPL 2 12hr

59.0

541034

54.1

SPL 3 12hr

47.7

488835

48.9

SPL 1 24hr

51.7

507445

50.7

SPL 2 24hr

61.1

559708

56.0

SPL 3 24hr

52.6

539425

53.9

SPL 1 72hr

55.6

545592

54.6

SPL 2 72hr

64.2

588460

58.9

SPL 3 72hr

49.8

511104

51.1

SPL 1 168hr

55.6

545856

54.6

SPL 2 168hr

61.0

559220

55.9

SPL 3 168hr

50.7

519631

52.0

 

2.1.3-DISCUSSION

The definitive results obtained by ion chromatography were assessed for reproducibility from the triplicate flasks for all time points. This demonstrated mean relative standard deviation of 4.06% for sodium, 1.50% for potassium, 0.99% forsulphate and therefore the test was considered to be consistent across the flasks at all the time points.

Comparison of the results obtained in the test with the theoretical concentrations from the Certificate of Analysis (sodium 66.0 g/kg, potassium 313 g/kg,sulphate564 g/kg), demonstrates that the test item was essentially fully dissolved in the test media at all time points.

The pH of the test solutions was stable (<0.2 pH unit deviation) over the duration of the study.  

The dissolved oxygen level in all the test solutions was greater than 70% saturation (6.0 mg/L) and thus satisfied the guideline.

The calcium content of the solutions was not determined since there was a significant amount of calcium present in the test medium, and therefore it was considered that it would not be possible to obtain reliable results.

The ICP-MS confirmatory analysis demonstrated no significant difference in the levels of sodium, potassium andsulphate in the samples solutions.

The study results reported from the ion chromatography analysis were considered acceptable.

 

2.2-TRANSFORMATION/DISSOLUTION AT PH 2

2.2.1-ION CHROMATOGRAPHY

Sodium

Sample

Meanconcentration

(g/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 0hr

0.236

2.31 x 104

2.31

SPL 2 0hr

0.276

2.65 x 104

2.66

SPL 3 0hr

0.285

2.75 x 104

2.75

SPL 1 0.5hr

0.537

5.26 x 104

5.26

SPL 2 0.5hr

0.546

5.26 x 104

5.26

SPL 3 0.5hr

0.537

5.19 x 104

5.19

SPL 1 2hr

0.590

5.78 x 104

5.78

SPL 2 2hr

0.534

5.14 x 104

5.14

SPL 3 2hr

0.547

5.29 x 104

5.29

SPL 1 4hr

0.528

5.18 x 104

5.18

SPL 2 4hr

0.550

5.30 x 104

5.30

SPL 3 4hr

0.559

5.40 x 104

5.40

SPL 1 6hr

0.541

5.30 x 104

5.30

SPL 2 6hr

0.535

5.15 x 104

5.15

SPL 3 6hr

0.541

5.23 x 104

5.23

 

Potassium

Sample

Meanconcentration

(g/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 0hr

1.69

1.66 x 105

16.6

SPL 2 0hr

1.97

1.90 x 105

19.0

SPL 3 0hr

1.88

1.81 x 105

18.1

SPL 1 0.5hr

3.36

3.29 x 105

32.9

SPL 2 0.5hr

3.42

3.30 x 105

33.0

SPL 3 0.5hr

3.40

3.29 x 105

32.9

SPL 1 2hr

3.48

3.41 x 105

34.1

SPL 2 2hr

3.40

3.28 x 105

32.8

SPL 3 2hr

3.40

3.28 x 105

32.8

SPL 1 4hr

3.34

3.27 x 105

32.7

SPL 2 4hr

3.42

3.29 x 105

32.9

SPL 3 4hr

3.38

3.27 x 105

32.7

SPL 1 6hr

3.33

3.26 x 105

32.6

SPL 2 6hr

3.43

3.30 x 105

33.0

SPL 3 6hr

3.36

3.25 x 105

32.5

 

Calcium

Sample

Meanconcentration

(g/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 0hr

2.60 x 10-2

2.55 x 103

0.255

SPL 2 0hr

2.37 x 10-2

2.28 x 103

0.228

SPL 3 0hr

3.04 x 10-2

2.94 x 103

0.294

SPL 1 0.5hr

3.47 x 10-2

3.40 x 103

0.340

SPL 2 0.5hr

3.41 x 10-2

3.29 x 103

0.329

SPL 3 0.5hr

3.24 x 10-2

3.14 x 103

0.314

SPL 1 2hr

3.71 x 10-2

3.64 x 103

0.364

SPL 2 2hr

3.49 x 10-2

3.36 x 103

0.336

SPL 3 2hr

3.33 x 10-2

3.22 x 103

0.322

SPL 1 4hr

3.32 x 10-2

3.25 x 103

0.325

SPL 2 4hr

3.48 x 10-2

3.35 x 103

0.335

SPL 3 4hr

3.37 x 10-2

3.25 x 103

0.325

SPL 1 6hr

3.08 x 10-2

3.01 x 103

0.301

SPL 2 6hr

3.44 x 10-2

3.32 x 103

0.332

SPL 3 6hr

3.47 x 10-2

3.35 x 103

0.335

 

Sulphate

Sample

Meanconcentration

(g/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 0hr

3.18

3.11 x 105

31.1

SPL 2 0hr

3.65

3.52 x 105

35.2

SPL 3 0hr

3.51

3.39 x 105

33.9

SPL 1 0.5hr

6.08

5.96 x 105

59.6

SPL 2 0.5hr

6.20

5.97 x 105

59.7

SPL 3 0.5hr

6.15

5.95 x 105

59.5

SPL 1 2hr

6.31

6.18 x 105

61.8

SPL 2 2hr

6.19

5.96 x 105

59.6

SPL 3 2hr

6.16

5.95 x 105

59.5

SPL 1 4hr

6.05

5.93 x 105

59.3

SPL 2 4hr

6.19

5.96 x 105

59.6

SPL 3 4hr

6.14

5.94 x 105

59.4

SPL 1 6hr

6.04

5.92 x 105

59.2

SPL 2 6hr

6.16

5.93 x 105

59.3

SPL 3 6hr

6.11

5.91 x 105

59.1

 

2.2.2-ICP-MS (confirmatory analysis)

From the analysis of the sample solutions, the counts per second for each analyte were interpolated from the respective calibrations to give the concentration of analyte (mg/L). The mean concentrations (g/L), concentration per unit mass (mg/kg) and percentage recovery for the sodium, potassium, calcium and sulphate analyses are shown in the following tables:

Sodium

Sample

Meanconcentration

(g/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 0hr

0.401

3.93 x 104

3.93

SPL 2 0hr

0.547

5.27 x 104

5.27

SPL 3 0hr

0.369

3.56 x 104

3.56

SPL 1 0.5hr

0.596

5.84 x 104

5.84

SPL 2 0.5hr

1.04

1.00 x 105

10.0

SPL 3 0.5hr

0.917

8.87 x 104

8.87

SPL 1 2hr

0.707

6.92 x 104

6.92

SPL 2 2hr

1.01

9.78 x 104

9.78

SPL 3 2hr

0.971

9.39 x 104

9.39

SPL 1 4hr

0.663

6.50 x 104

6.50

SPL 2 4hr

1.11

1.07 x 105

10.7

SPL 3 4hr

0.844

8.16 x 104

8.16

SPL 1 6hr

0.721

7.07 x 104

7.07

SPL 2 6hr

1.06

1.02 x 105

10.2

SPL 3 6hr

0.963

9.31 x 104

9.31

 

Potassium

Sample

Meanconcentration

(g/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 0hr

2.10

2.06 x 105

20.6

SPL 2 0hr

2.73

2.63 x 105

26.3

SPL 3 0hr

2.70

2.61 x 105

26.1

SPL 1 0.5hr

3.75

3.67 x 105

36.7

SPL 2 0.5hr

4.82

4.64 x 105

46.4

SPL 3 0.5hr

4.89

4.73 x 105

47.3

SPL 1 2hr

3.82

3.75 x 105

37.5

SPL 2 2hr

4.57

4.40 x 105

44.0

SPL 3 2hr

4.93

4.77 x 105

47.7

SPL 1 4hr

3.77

3.70 x 105

37.0

SPL 2 4hr

5.24

5.05 x 105

50.5

SPL 3 4hr

5.02

4.85 x 105

48.5

SPL 1 6hr

3.94

3.86 x 105

38.6

SPL 2 6hr

4.72

4.55 x 105

45.5

SPL 3 6hr

4.99

4.82 x 105

48.2

 

Calcium

Sample

Meanconcentration

(g/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 0hr

2.51 x 10-2

2.46 x 103

0.246

SPL 2 0hr

2.44 x 10-2

2.35 x 103

0.235

SPL 3 0hr

2.48 x 10-2

2.40 x 103

0.240

SPL 1 0.5hr

3.28 x 10-2

3.22 x 103

0.322

SPL 2 0.5hr

4.07 x 10-2

3.93 x 103

0.393

SPL 3 0.5hr

3.61 x 10-2

3.49 x 103

0.349

SPL 1 2hr

3.63 x 10-2

3.56 x 103

0.356

SPL 2 2hr

3.90 x 10-2

3.76 x 103

0.376

SPL 3 2hr

3.47 x 10-2

3.35 x 103

0.335

SPL 1 4hr

3.31 x 10-2

3.25 x 103

0.325

SPL 2 4hr

3.73 x 10-2

3.60 x 103

0.360

SPL 3 4hr

3.10 x 10-2

3.00 x 103

0.300

SPL 1 6hr

3.48 x 10-2

3.41 x 103

0.341

SPL 2 6hr

4.24 x 10-2

4.09 x 103

0.409

SPL 3 6hr

3.51 x 10-2

3.39 x 103

0.339

 

Sulphate

Sample

Meanconcentration

(mg/L)

Meanconcentration (mg/kg)

Recovery

(%)

SPL 1 0hr

2.60 x 103

2.55 x 105

25.5

SPL 2 0hr

3.34 x 103

3.27 x 105

32.7

SPL 3 0hr

3.40 x 103

3.33 x 105

33.3

SPL 1 0.5hr

4.68 x 103

4.58 x 105

45.8

SPL 2 0.5hr

5.58 x 103

5.47 x 105

54.7

SPL 3 0.5hr

5.46 x 103

5.35 x 105

53.5

SPL 1 2hr

4.52 x 103

4.42 x 105

44.2

SPL 2 2hr

5.65 x 103

5.54 x 105

55.4

SPL 3 2hr

5.66 x 103

5.55 x 105

55.5

SPL 1 4hr

4.65 x 103

4.56 x 105

45.6

SPL 2 4hr

5.44 x 103

5.33 x 105

53.3

SPL 3 4hr

5.47 x 103

5.36 x 105

53.6

SPL 1 6hr

4.57 x 103

4.48 x 105

44.8

SPL 2 6hr

5.76 x 103

5.64 x 105

56.4

SPL 3 6hr

6.16 x 103

6.04 x 105

60.4

 

2.2.3-DISCUSSION

The definitive results obtained by ion chromatography were assessed for reproducibility from the triplicate flasks for all time points. This demonstrated mean relative standard deviations of 3.89% for sodium, 2.07% for potassium, 6.13% for calcium and 1.80% for sulphate. Sodium, potassium and sulphate analysis were considered to be consistent (<5% RSD) across the flasks at all the time points. The higher variability in the calcium results was considered to be due to lower concentrations present in the sample solutions.

Comparison of the results obtained in the test with the theoretical concentrations from the Certificate of Analysis (sodium 66.0 g/kg, potassium 313 g/kg, sulphate 564 g/kg, calcium 0.285 g/kg), demonstrates that the test item was essentially fully dissolved in the test media after 30 minutes.

Although the ICP-MS confirmatory analysis demonstrated minor differences in reported concentrations, the analysis served to confirm the analyte species and approximate levels in the sample solutions. 

For the analysis by IC, matrix blanks were demonstrated generally low and inconsistent peak areas, therefore it was not considered necessary to correct the sample results for the contribution from the matrix blanks. In the ICP-MS analysis, matrix blanks were significant for sulphur(sulphate analysis) and therefore matrix blank corrections were applied to all ICP-MS analysis.

At each time point from 0.5 hour onwards, all of the samples were observed to be clear colorless and free from excess undissolved test item.

The pH of all the test solutions increased after addition of test item to pH 2.3 and remained stable throughout the duration of the test.   

The dissolved oxygen level in all the test solutions was greater than 70% saturation (6.0 mg/L) and thus satisfied the guideline.

 

 

Conclusions:
The transformation/dissolution of the test item in reconstituted standard water based on ISO6341 at pH 7 at 100 mg/L at 20± 1 °C has been determined by ion chromatography. The results demonstrate that the test item is effectively completely transformed/dissolved within 2 hours.
The transformation/dissolution of the test item in purified water adjusted to pH 2 at 10 g/L at 37 °C ± 1 °C has been determined by ion chromatography. The results demonstrate that the test item is effectively completely transformed/dissolved within 30 minutes.
Executive summary:

The transformation/dissolution of the test item has been determined using a GLP-compliant procedure designed to be compatible with Annex 10, Guidance on Transformation/Dissolution of Metals and Metal Compounds in Aqueous Media, OECD Environment, Health and Safety Publications, Series on Testing and Assessment, No.29, Environment Directorate,Organisationfor Economic Co-operation and Development, 23 July 2001.

The results are summarized below:

The transformation/dissolution of the test item in reconstituted standard water based on ISO6341 at pH 7 at 100 mg/L at 20 ± 1 °C has been determined by ion chromatography. The results of the analysis by ion chromatography are shown in the following table:

Shaking time at 20°C (hours)

Sodium
(g/kg)

Potassium
(g/kg)

Sulphate
(g/kg)

Residue
(g/kg)

Total recovery (%)

2

67.2

330

574

-

97.1

6

69.8

331

577

-

97.7

12

68.3

331

576

-

97.5

24

70.9

331

575

-

97.7

72

63.6

331

574

-

96.9

168

68.6

340

577

None detected

98.6

The results demonstrate that the test item is effectively completely transformed/dissolved within 2 hours into  Na+, K+, SO4-- ions when added in ISO 6341 medium at pH 7 and  20°C (calcium was not analysed because its level in EXP was too low compared to the concentration of calcium in the tested medium).

The transformation/dissolution of the test item in pH 2 purified water at 10 g/L at 37 °C ± 1 °C has been determined by ion chromatography. The results of the analysis by ion chromatography are shown in the following table:

Shaking time at 37°C (hours)

Sodium
(g/kg)

Potassium
(g/kg)

Calcium
(g/kg)

Sulphate (g/kg)

Residue

(g/kg)

Total recovery (%)

0

25.7

179

2.59

334

-

54.1

0.5

52.4

329

3.28

596

-

98.1

2

54.0

332

3.41

603

-

99.3

4

52.9

328

3.29

594

-

97.8

6

52.3

327

3.23

592

4.0

97.4

The results demonstrate that the test item is effectively completely transformed/dissolved within 30 minutes into Na+, K+, Ca++, SO4-- ions when added in purified water at pH 2 and  37°C.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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