Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: the estimated DL50 value is higher than 2000 mg/kg bw.
Acute inhalation toxicity: no DL50 value may be estimated. The substance can cause adverse effects to the lungs.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 001 mg/kg bw

Additional information

Study results indicate that the barium hexaferrite does not cause any acute toxic effect when it is administered at 2000 mg/kg by oral route.

Study results indicate that the inhaled barium hexaferrite powder can be retained inside the lungs for a long time period even after an acute inhalation exposure. As described in the Kosova et al (1972) paper, the substance can cause adverse local effects (as fibrosis) which are manifested after a long time period.

Read-across justification: data regarding barium hexaferrite are provided as key study; at the same time further literature data concerning other substances, which are deemed closely similar, are reported as supporting studies.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that the substance should not be classified for acute oral toxicity.

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified for acute toxicity by inhalation route in terms of mortality, but requires STOT SE cat 2 H371 for its effects on lungs by inhalation.