Registration Dossier

Administrative data

Description of key information

Both in vitro skin corrosion and skin irritation tests gave negative results. Moreover, in vivo studies mentioned in the medical Russian literature support the lack of skin irritating effects due to barium hexaferrite. Barium hexaferrite is not an eye irritant in vitro testing.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

In vitro tests on skin corrosion/irritation have been conducted in 2010 according to validated methods; in addition an in vivo test (as preliminary study of a guinea pig maximization test) was performed too. All carried out tests gave negative results. In vivo further testing was deemed not necessary at present, considering the coherence of available experimental results with old in vivo Russian literature data (Ermachencko, 1987) which document the lack of in vivo skin irritation.

In vitro test on eye irritation showed negative results. In vivo further testing was deemed not necessary, as the frictional action of the powder may significantly interfere with results, giving false positive responses not related to the chemical action.

Read-across justification: experimental data obtained with barium hexaferrite in in vitro eye irritation test, are evaluated together with clinical observations coming from the practical experience with iron oxide eye exposure. Indeed, both substances of interest are water insoluble and rather inert (intended as non reactive in contact with skin and mucous); it is deemed, in this context, that they can be jointly evaluated.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified neither for skin corrosion/irritation nor for eye irritation.