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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP but other quality assurance
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Principles of method if other than guideline:
Metal bioavailability was estimated through in vitro bio-accessibility testing in accordance Standard Operating Procedure (SOP) for Bioelution Testing of Metals, Inorganic Metal Compounds, and Metal-Containing Complex Materials: Simulated Gastric Fluid (Eurometaux, July 2016) which is based on ASTM D5517-07. Metal released to the medium were determined after 1 hour of agitation in a thermostatic orbital shaker at an agitation rate of 100 rpm and another hour to allow the sample to settle at 37°C.
GLP compliance:
no
Remarks:
other quality assurance

Test material

Constituent 1
Reference substance name:
slag, copper smelting
EC Number:
266-968-3
Cas Number:
67711-92-6
IUPAC Name:
slag, copper smelting
Details on test material:
The following samples were assesed:
Type Sample code
I, Granules, primary 6522
I, Granules, primary 6970
I, Granules, primary 7415
II, Granules, secondary 6366
II, Granules, secondary 6524
II, Granules, secondary 7000
III, Slow cooled, primary, stones 6361
III, Slow cooled, primary, stones 7410
IV, Slow cooled, secondary, stones 6520
III, Slow cooled, primary, fines 6519
II, Granules, secondary, fines 6172
Sample collection made according to the C1-sampling protocol (see IUCLID section 1.4)

Administration / exposure

Vehicle:
other: HCl 0.07 N, pH 1.5
Duration and frequency of treatment / exposure:
1 hour agitation and 1 hour to allow the sample to settle

Results and discussion

Any other information on results incl. tables

Results provide a conservatove estimate of the bioaccesability of metals in copper final slag.

Elemental composition and metal concentrations obtained after bioelution tests

 

Type

Sample

Metal

Composition, (%)

Bio-elution

(200 mg/l), µg/L

Relative release (%)

Bioaccessible concentration,

(%)

I, Granules, primary

6522

As

<0.01

0.6

-

0.000

Cd

<0.005

<0.05

-

0.000

Co

0.351

8.6

1.20%

0.004

Cr

0.146

29.1

10.00%

0.015

 

 

Cu

0.622

71.00

5.70%

0.035

Mo

0.15

40.40

13.00%

0.020

Ni

0.03

5.40

9.00%

0.003

Pb

0.019

2.90

7.60%

0.001

Zn

0.997

157

7.90%

0.078

I, Granules, primary

6970

As

0.1

7.8

3.90%

0.004

Cd

<0.01

0.14

-

0.000

Co

0.021

1.3

3.10%

0.001

Cr

0.019

<0.5

<0.13%

0.000

 

 

Cu

1.27

52

2.10%

0.027

Mo

0.627

33.7

2.70%

0.017

Ni

<0.02

0.7

-

0.000

Pb

0.181

11.2

3.10%

0.006

Zn

0.939

51

2.70%

0.025

I, Granules, primary

7415

As

0.08

5

3.10%

0.002

Cd

<0.01

0.63

-

0.000

Co

0.02

1.6

3.90%

0.001

Cr

0.04

<0.5

<0.063%

0.000

 

 

Cu

0.88

36

2.00%

0.018

Mo

0.17

9.3

2.70%

0.005

Ni

0.05

1.8

1.80%

0.001

Pb

0.28

19.1

3.40%

0.010

Zn

1.38

74

2.70%

0.037

II, Granules, secondary

6366

As

<0.01

<0.5

-

0.000

Cd

<0.005

0.11

-

0.000

 

 

Co

0.04

8.4

10.00%

0.004

Cr

0.661

11.7

0.88%

0.006

Cu

0.49

42

4.30%

0.021

Mo

0.028

7.2

13.00%

0.004

Ni

0.022

2.3

5.30%

0.001

Pb

0.452

93.5

10.00%

0.045

Zn

5.84

1828

16.00%

0.934

II, Granules, secondary

6524

As

<0.01

<0.5

-

0.000

Cd

<0.005

<0.05

-

0.000

 

 

Co

0.041

2.9

3.50%

0.001

Cr

1.07

1.8

0.08%

0.001

Cu

1.12

41

1.80%

0.020

Mo

0.054

4.1

3.80%

0.002

Ni

0.168

7.5

2.20%

0.004

Pb

0.313

17

2.70%

0.008

Zn

3.51

157

2.20%

0.077

II, Granules, secondary

7000

As

<0.01

<0.5

-

0.000

Cd

<0.01

0.11

0.54%

0.000

 

 

Co

0.031

3.7

6.00%

0.002

Cr

0.855

2.7

0.16%

0.001

Cu

1.33

103

3.90%

0.052

Mo

0.038

5

6.60%

0.003

Ni

0.118

5.2

2.20%

0.003

Pb

0.237

48.5

10.00%

0.024

Zn

5.6

670

6.00%

0.353

III, Slow cooled, primary, stones

6361

As

<0.03

0.50

-

0.000

Cd

<0.005

<0.05

-

0.000

 

 

Co

0.159

5.7

1.80%

0.003

Cr

0.16

<0.5

<0.16%

0.000

Cu

0.433

19

2.10%

0.009

Mo

0.051

1.6

1.60%

0.001

Ni

0.014

1.1

4.00%

0.001

Pb

0.277

21.5

3.80%

0.011

Zn

0.82

27

1.60%

0.013

III, Slow cooled, primary, stones

7410

As

0.08

<0.5

0.00%

0.000

Cd

<0.005

0.08

0.82%

0.000

 

 

Co

0.03

0.9

1.60%

0.001

Cr

0.04

<0.5

0.00%

0.000

Cu

0.62

22

1.70%

0.011

Mo

0.13

0.5

0.21%

0.000

Ni

0.04

1.6

2.00%

0.001

Pb

0.26

4.7

0.90%

0.002

Zn

1.23

23

0.91%

0.011

IV, Slow cooled, secondary, stones

6520

As

<0.01

<0.5

-

0.000

Cd

<0.005

<0.05

-

0.000

 

 

Co

0.048

2.6

2.70%

0.0013

Cr

0.706

<0.5

<0.035%

0.000

Cu

1.15

101

4.40%

0.051

Mo

0.021

2.1

4.90%

0.001

Ni

0.24

5.7

1.20%

0.003

Pb

0.43

119

14.00%

0.060

Zn

3.18

166

2.60%

0.083

III, Slow cooled, primary, fines

6519

As

0.073

17.1

12.00%

0.009

Cd

<0.005

0.5

-

0.000

 

 

Co

0.065

21.5

17.00%

0.011

Cr

<0.03

<0.5

-

0.000

Cu

0.412

136

17.00%

0.070

Mo

0.086

2.3

1.30%

0.001

Ni

0.118

20.2

8.60%

0.010

Pb

0.272

48.2

8.80%

0.024

Zn

1.21

286

12.00%

0.145

II, Granules, secondary,

6172

As

<0.03

<0.5

-

0.000

fines

Cd

<0.005

0.25

-

0.000

Co

0.059

9.9

8.40%

0.005

Cr

0.44

9.7

1.10%

0.005

Cu

0.509

46

4.50%

0.023

Mo

0.017

4.4

13.00%

0.002

Ni

0.028

3

5.20%

0.001

Pb

0.577

107

9.30%

0.054

Zn

5.66

1273

11.00%

0.623

 

 

Applicant's summary and conclusion

Conclusions:
The study can be used to estimate the amounts of metals in copper slag that are readily available for absorbtion and support conclusions on hazard classification.
Executive summary:

In-vitro bio-accessibility tests were performed in solvent that resembles gastric fluid according to the recommended Standard Operating Procedure (SOP) for Bioelution Testing of Metals, Inorganic Metal Compounds, and Metal-Containing Complex Materials: Simulated Gastric Fluid (Eurometaux, July 2016) which is based on ASTM D5517-07. The extent of dissolution of Copper final slags was investigated by exposing the slags to simulated gastric fluid at 37 °C and at pH 1.5 for 2 hours (0.2 g/L and 2 g/L loading). During the experiment the test vessels were agitated at a speed of 100 revolutions per minute (rpm) for 1 hour followed by 1 hour of setting (without shaking). The fraction of metals that solubilize under these conditions can be considered as worst case determinant of bio-accessibility of metals contained in the slag. The bio-elution endpoints were based on the dissolved arsenic, cadmium, cobalt, copper, chromium, molybdenum, nickel, lead and zinc concentrations obtained after 2 hours of extraction. Results demonstrate reduced relative bio-accessibility of metals (relative releases Cu 0.02 – 0.17, Co 0.01-0.17, Ni 0.01 – 0.09, Pb 0.01 – 0.14).