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EC number: 273-729-7 | CAS number: 69012-29-9 By-product from the production of ferronickel from a complex ore. Consists primarily of oxides of aluminum, iron, magnesium and silicon.
Endpoint summary
Administrative data
Description of key information
Slags, ferronickel-manufg is not expected to be absorbed via the gastrointestinal tract after oral administration. This is inferred by the study of acute toxicity via oral route (conducted as limit test) where no sign of systemic toxicity was found at a dose of 2000mg/kg bw. Acute toxicity via inhalation route also showed no adverse effect in a nominal atmosphere containing 5.16 mg/m3.
Studies on dermal exposure were disregarded since dermal contact in the production and/or use is unlikely and inhalation is likely
Key value for chemical safety assessment
Additional information
Two grades of slag are considered for the purposes of the registration dossier, Electric Arc Furnace slag (EFS) and Converter Slag (CS). Both contain high levels of iron oxides, but CS contains higher amounts of the skin irritant Calcium Oxide and of metallic nickel. EFS contains higher levels of silicon dioxide, which has, however, been proven to be amorphous after XRD analysis with Rietveld quantitative phase analysis. Additionaly, no hexavalent Cr was detected after alkaline digestion (EPA method 3060A) and colorimetric analysis in various grades of Ferronickel slags from different production facilities (EPA method 7196A). It is therefore considered that CS is capable of producing stronger toxicological responses and this quality has been used as the test substance, whenever a test was identified to be required. Results obtained with CS can be safely considered valid for EFS as well.
Acute oral toxicity:
Under the conditions of the present study, a single oral application of the test item Slags, ferronickel-manufg. / Electric Furnace Slag / Converter Slag to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.
The median lethal dose of Slags, ferronickel-manufg. / Electric Furnace Slag / Converter Slag after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): unclassified
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC [7] the test item Slags, ferronickel-manufg. / Electric Furnace Slag / Converter Slag has no obligatory labelling requirement for toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item Slags, ferronickel-manufg. / Electric Furnace Slag / Converter Slag has no obligatory labelling requirement for toxicity and is unclassified.
According to OECD-GHS (Globally Harmonised Classification System) the test item Slags, ferronickel-manufg. / Electric Furnace Slag / Converter Slag has no obligatory labelling requirement for toxicity.
Inhalation toxicity:
An acute inhalation toxicity test was conducted with rats to determine the potential for Slags, Ferronickel-manufg., CAS No: 69012-29-9, to produce toxicity from a single exposure via the inhalation (nose-only exposure) route. Under the conditions of this study, the single exposure acute inhalation LC50 of the test substance is greater than 5.16 mg/L in male and female rats. After establishing the desired generation procedures during pre-test trials, ten healthy rats (5/sex) were exposed to the test atmosphere for 4 hours. Chamber concentration and particle size distributions of the test substance were determined periodically during the exposure period. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days following exposure. Body weights were recorded prior to exposure and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.
The substance showed no toxic or other adverse effects after the exposure of ten rats to a concentration of 5.15mg/l. The substance is considered non-toxic for inhalatory exposure.
On the basis of the test results of the acute inhalation toxicity test and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC as well as in Annex I of Regulation (EC) 1272/2008, the substance should be:not classified for acute inhalation toxicity
Acute dermal toxicity
The rules for adaptation in Column 2 of the REACH Annex VIII state that, “in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 [inhalation and dermal acute toxicity] shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided”. The rules for adaptation also state that, “Testing by the dermal route is appropriate if…(1) inhalation of the substance is unlikely…”. As oral and inhalation routes of exposure are more relevant and data for these have been provided, testing for acute dermal toxicity is therefore waived based on this information. Furthermore, dermal toxicity of the constituents of the substance is insignificant, based and on their low water solubility. (see also CSR).
Justification for classification or non-classification
Slags, ferronickel-manufg is not expected to be absorbed via the gastrointestinal tract after oral administration. This is inferred by the study of acute toxicity via oral route (conducted as limit test) where no sign of systemic toxicity was found at a dose of 2000mg/kg bw. Acute toxicity via inhalation route also showed no adverse effect in a nominal atmosphere containing 5.16 mg/m3.
On the basis of the test results of the acute oral toxicity test and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC as well as in Annex I of Regulation (EC) 1272/2008, the substance should be:not classified for acute oral toxicity
On the basis of the test results of the acute inhalation toxicity test and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC as well as in Annex I of Regulation (EC) 1272/2008, the substance should be:not classified for acute inhalation toxicity
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