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EC number: 920-632-9
CAS number: -
Complex metal containing substanceWater solubility of the substance is poor (for metal constituents)Several high quality studies on nickel slag and analogue substance (copper slag) demonstrate no negative effects .An LDs 50 of > 2000 mg/kg bw were assessed. Nickel slag is considered non toxic via oral, dermal and inhalation route.Classification based on rules for mixtures In vitro bio-accessability in artificial biological fluids ( gastric and sweat)
The nickel slag is a complex metal containing
substance (UVCB). It
mainly contains iron silicate and silicates of aluminum and calcium.
Traces of metals exist in metal, mineral form or included in silicate
Substance is used in massive or granular form
with varying particle size distribution (IUCLID section 4.5). Routes for
exposure to consider are therefore oral and inhalation.
Nickel slag is inorganic solid poorly soluble
in water. It is not
likely to penetrate though organic media. Absorption of nickel slag
through the skin is therefore considered to be of less significance than
absorption through the respiratory and gastrointestinal routes.
The following test data
were obtained for the analogue substance (copper slag)
- The acute oral effects - LD50>
2000 mg/kg (3 studies)
- The acute dermal effects - LD50>
2000 mg/kg (2 studies)
These data are used to predict the absence of
acute oral and dermal effects (LD50> 2000 mg/kg ) for the
nickel slag based on read accross from the analogue substance.
Additionally classification of the nickel
slag was derived based on rules for mixtures:
calculated Oral Acute toxicity estimate of the mixture is > 2000 mg/kg
calculated Inhalation Acute toxicity estimate of the mixture is > 5mg/l
Results from calculated classification are
further supported (WoE) by consideration of physical chemical properties
of the UVCB substance.
Chemistry and mineralogy of the slag (see
IUCLID section 4.23 chemical and mineralogical characterization) were
taken into account.
Water solubility (IUCLID section 4.8) and
Sequential dissolutions (IUCLID 4.23 Chemical assays) furthermore
confirmed species present and their solubility behavior.
In vitro measurements of bio-accessibility in
solvent that resembles gastric fluid performed according to ASTM
D5517.07. (pH 1.5) The
fraction of metals that solubilize under these conditions can be
considered as worst case determinant of bio-associability of metals
contained in the slag. Results
demonstrated reduced bio-accessibility of metals (Cu 0.04, Ni 0.05, Co
0.06, dissolved concnetrations of Pb and As below detection limit) thus
further confirm that there is no need for classification.
Acute oral classification
Based on the available acute oral toxicity
data for the analogue substance (i. e LD50> 2000 mg/kg) and calculated
Oral Acute toxicity estimate (ATE >2000 mg/kg) nickel slag is not
classified as hazardous for acute toxicity by the oral route.
No test data on acute inhalation toxicity are
available. The calculated Inhalation Acute toxicity estimate of the
mixture is > 5mg/l thus nickel slag is not classified as hazardous for
acute toxicity by the inhalation route. Result is further confirmed by
extrapolation from oral to inhalation route based on worst case 100%
absorption rate. Using ATE oral: 2000 mg/kg bw and the extrapolation
formula 1mg/kgbw = 0.0052 mg/l/4h, theinhalation ATE will be 10.4
Consideration of available acute dermal
toxicity data on the analogue substance (i. e. LD50>2000
mg/kg) leads to the conclusion that the target substance nickel slag
does not require classification for acute lethal effects.
Nickel slag is an inorganic solid poorly
soluble in water. It is not likely to penetrate through skin in any
significant quantity and so would therefore not cause any toxic effects
following dermal exposure. Furthermore, negligible metal release in
in-vitro bio-accessibility test in artificial sweat fluid was observed
(0.018 µg Ni/cm2/week).
The classification derived is applicable
to all nickel slags.See end-point
record and discussion above for detailed justifications.
The assessed samples and derived
classifications are representative for typical nickel slags, across the
industry, and defined within the concentration ranges outlined under
IUCLID section 1.2.
Self-classification of the UVCB substance
(IUCLID Section 2.1 & 2.2) was performed based on the following outline:
The substance is accurately described with
elemental composition (typical concentrations and concentration
ranges–IUCLID Section 1.2), and specific speciation data (mineralogical
from the respective representative samples (IUCLID Section 4, in
particular 4.23). This detailed information on the substance identity is
used as a basis for the classification.
2. Classification by the rules for mixtures
The UVCB is considered as complex metal
containing substance with number of discrete constituents (metals, metal
compounds, non-metal inorganic compounds).
The classification is based on summation
(additivity) referring to the classified constituents present in the
UVCB substance. Specific concentration limits are taken into account.
This concept and classification rules are
incorporated in easy to use IT tool which is used to classify the UVCB
3. Bridging or Read-Across
Toxicological data (oral and dermal toxicity)
are available for the analogue/surrogate substance copper slag.
Read accross from the analogue substance
(copper slag) to the target substance (nickel slag) is applied
(structural analogues with similar chemical and mineralogical
composition and physical/chemical properties).
Considering variability in composition, read-across
and bridging is applied by using representative mineralogical/speciation
composition combined with the metal concentration ranges (see
composition in section 1.2) as a basis for the classification of the
UVCB substance see IUCLID 1.4 for information on Sampling procedure).
4. Bioavailability consideration
Data from bio-accessibility test in solutions
that resemble gastric fluid and sweat are used to further confirm the
SeeArche Complex Metal Mixture
classification calculator (copper version June 2010); MeCLAS webpage:
www. meclas. eu
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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