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:
4 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: German occupational value of the respirable fraction for inert dusts (Staubgrenzwert): 4 mg/m3
Overall assessment factor (AF):
1
Dose descriptor:
other: German occupational value of the respirable fraction for inert dusts (Staubgrenzwert): 4 mg/m3
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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

The substance is considered as insoluble and inert since water solubility is < 0.1 mg/L (see IUCLID chapter 4.8, water solubility) and a negligible bioavailability of the metal ions was proven for the inhalation and oral route (see IUCLID chapter 7.1.1 basic toxicokinetics).

For the assessment of the DNELs the German AGW value (maximum occupational limit; formerly MAK) for inert dusts was taken into account. In 1997, the German MAK commission stated the AGW of the respirable fraction of inert dusts to be 4 mg/m3 in order to prevent unspecific local effects in the respiratory tract (predominantly chronic bronchitis). This value is used for the derivation of the No Effect Level for long-term exposure of local effects.

The AGW of the alveolar fraction was stated to be 1.5 mg/m3.

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 pure substance is not handeled by the general population and has no consumer use. The concentration in articles is 5% maximum.