Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The possible allergenic activity of slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) was tested according to OECD 406 and NF EN ISO 10993-10 (February 2003) concerning biological evaluation of medical devices: Tests for irritation and delayed-type hypersensitivity.Slag leachate was prepared by DIN 38414 -4 DEV S-4 by leaching for 24 h at a liquid/solid ratio of 10/1. For indcution, 21 Guinea pigs were exposed to the leachate in triplicate topical applications under occlusive dressing for 6 h, at 100%. After a 14-day rest phase, the challenge phase consisted of a single topical application (24 h) of the leachate at 100% and 50% dilution in demineralised water. No visible cutaneous reactions and no intolerance reaction were recorded in the challenge phase neither at 100% nor at 50%, and no reaction was recorded in the negative controls.Slag, ferrous metal, blast furnace is not irritating and does not need to be classified as a skin sensitiser. No signal word and no hazard statement are required.


Migrated from Short description of key information:
Slags, ferrous metal, blast furnace (air cooled – ABS) are not sensitizing when tested according to OECD 406 and NF EN ISO 10993-10 (February 2003) concerning biological evaluation of medical devices: Tests for irritation and delayed-type hypersensitivity.

Respiratory sensitisation

Endpoint conclusion
Additional information:

There is no indication of any sensitizing effect of ferrous slag.


Migrated from Short description of key information:
No data available

Justification for classification or non-classification

There is no skin sensitisation potential of slags, ferrous metal, blast furnace, as shown in a test according to OECD 406