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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Slags, ferronickel-manufg. /Electric Furnace Slag/ Converter Slag was tested for dermal sensitising properties according to the OECD Guidelines for Testing of Chemicals, number 429, “Skin Sensitisation: Local Lymph Node Assay” (adopted: July 22, 2010).

Based on the results of the preliminary test the test item was extracted according to ISO 10993-12 and assessed for sensitising properties at extract concentrations of 25 %, 50 % and 100 % (v/v).

The stimulation index at an extract concentration of 25% was1.1

The stimulation index at an extract concentration of 50% was1.2

The stimulation index at an extract concentration of 100% was1.1

At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality were observed.

Species/strain: Mice, CBA/CaOlaHsd

Number of animals:20/main test

Vehicle: AOO (3+1(v/v) acetone/olive oil)

The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3. Consequently, according to OECD 429 ISO 10993-12: 2007 “Sample preparation and reference materials” and the criteria given in Annex I of Regulation (EC) 1272/2008 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Official Journal of the European Communities, L 353, 31.12.2008, the test item Slags, ferronickel-manufg. /Electric Furnace Slag/ Converter Slag, as described in this report is expected to have no sensitising properties and therefore, should not be regarded as a dermal sensitiser.


Migrated from Short description of key information:
The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3. Consequently, according to OECD 429 ISO 10993-12: 2007 “Sample preparation and reference materials” and the criteria given in Annex I of Regulation (EC) 1272/2008 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Official Journal of the European Communities, L 353, 31.12.2008, the test item Slags, ferronickel-manufg./Electric Furnace Slag/ Converter Slag, as described in this report is expected to have no sensitising properties and therefore, should not be regarded as a dermal sensitiser.
The substance contains Nickel metal, which is classified as skin sensitiser 1. However, it is bound in the matrix of the slags and it exists in a low concentration (<0.5% w/w), not sufficient for classification, if the substance were to be regarded as a mixture. However, the test results show that no skin sensitising properties occur.
The test was performed on a grade of slags, ferronickel-manufg. with a high content of Nickel, which is the most notorious substance in regards to sensitisation. Since no effects were observed, no grade of the substance should be classified or considered a sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

According to ECHA Guidance Document R.7A, a chemical which fails to induce a positive response in LLNA testing most probably lacks the potential for respiratory allergy. Therefore, converter slag is not considered a respiratory allergen.


Migrated from Short description of key information:
According to ECHA Guidance Document R.7A, a chemical which fails to induce a positive response in LLNA testing most probably lacks the potential for respiratory allergy. Therefore, converter slag is not considered a respiratory allergen.

Justification for classification or non-classification

The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3. Consequently, according to OECD 429 ISO 10993-12: 2007 “Sample preparation and reference materials” and the criteria given in Annex I of Regulation (EC) 1272/2008 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Official Journal of the European Communities, L 353, 31.12.2008, the test item Slags, ferronickel-manufg./Electric Furnace Slag/ Converter Slag, as described in this report is expected to have no sensitising properties and therefore, should not be regarded as a dermal sensitiser. The substance contains Nickel metal, which is classified as skin sensitiser 1. However, it is bound in the matrix of the slags and it exists in a low concentration (<0.5% w/w), not sufficient for classification, if the substance were to be regarded as a mixture. However, the test results show that no skin sensitising properties occur.

It is advisable however, that in the SDS the presence of Nickel metal should be mentioned.

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