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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:
2010
Report date:
2010

Materials and methods

Principles of method if other than guideline:
Metal release in human digestive system was estimated through in vitro bio-accessibility test in extraction solvent that resembles gastric fluid (using HCl 0.07N at pH 1.5) in accordance with the ASTM D 5517-07 standard. Metal released to the medium were determined after 1 hour of agitation at 171 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, nickel smelting
IUPAC Name:
Slag, nickel smelting
Details on test material:
The following sample was assesed:
Sample Code Sample size Description
4683 Less 500 μm C2 Nickel Slag, Granules

Sample collection made according to the C2-sampling protocol (see IUCLID section 1.4)

Administration / exposure

Vehicle:
other: HCl 0.07N ,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 nickel slag after ingestion.

Table 1.Bio-elution results of slag samples in gastric mimetic fluid. Test media was HCl 0.07N, pH 1.5 with 200 mg/L sample loading, an agitation rate of 171 rpm and 37°C. MDL= method detection limit (MDL) considering the dilution of the samples at 200 mg/L loading; BDL = Below detection limit (below MDL); Mean = Average concentration; SD = Standard deviation. 

 

Sample

Metal

Bio-elution (200 mg/L), µg/L

Mean               CV, %

MDL, µg/L

4883

C2 Slag

 granules

Cu

7.8                     10

0.8

Ni

16.1                    11

0.6

As

BDL                     -

2

Pb

BDL                     -

0.4

Zn

BDL                     -

10

Cd

0.03                    27

0.02

Mo

BDL                     -

3

Co

16.36                    15

0.01

 

Applicant's summary and conclusion

Conclusions:
The study can be used to estimate the amounts of metals in nickel 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 ( using HCl at pH 1.5) according to ASTM D5517.07.

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. Results demonstrate reduced relative bio- accessibility of metals (Cu 0.04, Ni 0.05, Co 0.06).Dissolved concentrations of Pb and As were below detection limit.