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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.