Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.25 mg/m³
DNEL related information
DNEL derivation method:
other: OEL from SCOEL for CrIII
Explanation for the modification of the dose descriptor starting point:

For CrIII a OEL was set by SCOEL at 0.5 mg/m3. This value was transfered to the value for the UVCB based on a CrIII content of 8%, leading to the value of 6.25 mg/m3.

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25 mg/m³
DNEL related information
Explanation for the modification of the dose descriptor starting point:

For CrIII a short-tterm OEL was set by SCOEL at 2 mg/m3. This value was transfered to the value for the UVCB based on a CrIII content of 8%, leading to the value of 25 mg/m3.

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
DNEL (Derived No Effect Level)
Value:
7.5 mg/kg bw/day
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The EFSA Contam Panel has derived a TDI of 0.3 mg/kg bw/d. For worker an adjustment factor of two was used leading to 0.6 mg/kg bw/d. This value was transfered to the value for the UVCB based on a CrIII content of 8%, leading to the value of 7.5 mg/kg bw/d.

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 mg/kg bw/day
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:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.25 mg/m³
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Same value as for worker was used, as route to route extrapolation from EFSA TDI leads to a higher value: 0.3 x70/20 = 1.05 mg/m3 CrIII => 13.125 mg/n3 UVCB

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.25 mg/m³
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:
DNEL (Derived No Effect Level)
Value:
3.75 mg/kg bw/day
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The EFSA Contam Panel has derived a TDI of 0.3 mg/kg bw/d. This value was transfered to the value for the UVCB based on a CrIII content of 8%, leading to the value of 3.75 mg/kg bw/d.

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.75 mg/kg bw/day
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:
DNEL (Derived No Effect Level)
Value:
3.75 mg/kg bw/day
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The EFSA Contam Panel has derived a TDI of 0.3 mg/kg bw/d. This value was transfered to the value for the UVCB based on a CrIII content of 8%, leading to the value of 3.75 mg/kg bw/d.

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.75 mg/kg bw/day
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population