Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Dose descriptor:
LOAEC
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

Workers - Hazard for the eyes

Additional information - workers

Descriptor choice

From the available data the most appropriate choice is the result of Gross et al, 1973 on subchronic toxicity of aluminium metal.

Corrected dose descriptor

 The descriptor has been corrected according to ECHA Guidance Document R.8 p 27

Assessment factors

  • Duration of exposure: The default assessment factor for extrapolation of exposure duration from sub-chronic to chronic exposure is 2 (ECHA Guidance Document R.8 p. 38). The duration of the study in question is longer than a standard sub-chronic but shorter than a standard chronic, nevertheless this factor has been chosen
  •  Interspecies difference: The default assessment factor for interspecies differences for local effects on the respiratory tract is 2.5 ECHA Guidance Document R.8 p. 38).
  •  Intraspecies difference: The default assessment factor for intraspecies differences is 5 ECHA Guidance Document R.8 p. 38).  Inhalable fraction: LOAEC calculated on fine aluminium dust (90% < 4μm) whereas aluminium dross consists of only 11% inhalable fraction (Smeykal, 2010). A final DNEL on total dust is extrapolated by division of DNEL by 0.11  Inhalable fraction: LOAEC calculated on fine aluminium dust (90% < 4μm) whereas aluminium dross consists of only 11% inhalable fraction (Smeykal, 2010). A final DNEL on total dust is extrapolated by division of DNEL by 0.11

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population