Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.15 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Based on experimental studies results, the inhaled barium hexaferrite powder can be retained in the lungs for a long time period. Inside the lungs, the substance can cause adverse local effects as fiber deposition and subsequently pneumoconiosis.

Therefore, a specific DNEL is established in order to characterize the risk for the long-term inhalation exposure.

Experimental data show that inhaled barium hexaferrite powder may induce pneumoconiosis (identified as critical effect) following repeated exposure at concentration higher than 30 mg/m3 (NOAEC). Starting from this value, a DNEL of 0,15 mg/m3 was derived using an assessment factor of 200 calculated as follows:

- 10 for intraspecies variability

- 10 for interspecies variability

- 2 for accounting of differences in daily duration of exposure (4 h/day in animals, 8 h/day workers).

Whilst the substance is acutely hazardous by inhalation (it is classified as STOT SE 2), a reliable D(M)NEL cannot be identified from the available data. The information has to be intended as a qualitative indication which allows to adopt all suitable risk management measures in case of incidents or massive substance releases.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The substance is provided to general population within articles (as polymer bonded magnet), which do not foresee any substance release. Consequently, general population exposure is not expected and no D(M)NEL has to be derived.