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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
176.3 mg/m³
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
DNEL (Derived No Effect Level)
Value:
250 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

The long-term systemic DNELs for workers are based on a subchronic 12 weeks oral gavage study performed on the read across substance Colloidal Prussian Blue, in which the subchronic oral NOAEL for rats was found to be ca. 2500 mg/kg bw/day.

DNELs were derived based on guidance document R8 (ECHA 2008).

Long-Term exposure-Systemic effects:

Dermal DNEL:

Assessment factors: inter species 4; remaining differences 2.5, intra species factor 5, and exposure duration factor 2.

Overall AF= 100

Rat oral NOAEL = ca. 2500 mg/ kg bw/day

A dermal absorption difference of 10% was used to modify the dose to the correct starting dose.

NAELcorr= 2500 mg/kg bw/d / 0.1 = 25000 mg/kg bw/day

DNEL = NAEL / AF = 25000 mg/kg bw/d / 100 = 250 mg/kg bw/day

 

Inhalation DNEL:

Assessment factors: inter species 2.5, intra species factor 5, and exposure duration factor 2.

Overall AF = 25

Rat oral NOAEL = 1000 mg/ kg bw/day

For calculating inhalation DNEL for workers, the oral NOAEL needs to be converted into an inhalatory NAECcorr rat by application of route-to route extrapolation:

NAECcorr= NOAEL x 1/0.38 x 6.7/10 = 4407.9 mg/m3/d

DNEL = NAECcorr/ AF = 4407.9 mg/m3/ 25 = 176.3 mg/m3

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.48 mg/m³
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
125 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.5 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

The long-term systemic DNELs for consumers are based on a subchronic 12 weeks oral gavage study performed on the read across substance Colloidal Prussian Blue, in which the subchronic oral NOAEL for rats was found to be ca. 2500 mg/kg bw/day.

DNELs were derived based on guidance document R8 (ECHA 2008).

Long term exposure-Systemic effects:

Dermal DNEL:

Assessment factors: inter species 4, remaining differences 2.5, intra species factor 10, and exposure duration factor 2.

Overall AF = 200

A dermal absorption difference of 10% was used to modify the oral NOAEL to the correct starting dose. NAELcorr= 2500 mg/kg bw/d / 0.1 = 25000 mg/kg bw/day

DNEL = NAEL / AF = 25000 mg/kg bw/d / 200 = 125 mg/kg bw/day

 

Inhalation DNEL:

Assessment factors: inter species 2.5, intra species factor 10, and exposure duration factor 2.

Overall AF= 50

Rat oral NOAEL = ca. 2500 mg/ kg bw/day

For calculating inhalation DNEL for consumers, the oral NOAEL needs to be converted into an inhalatory NAECcorr rat by application of route-to route extrapolation:

NAECcorr= NOAEL x 1 / 1.15 = 2173.9 mg/m3

DNEL = NAECcorr / AF = 2173.9 mg/m3/ 50 = 43.48 mg/m3

 

Oral DNEL:

Assessment factors: Inter species factor 2.5, allometric scaling factor 4, intra species factor 10, and exposure duration factor 2.

Overall AF = 200

DNEL = NOAEL / AF = 2500 mg/kg bw/d / 200 = 12.5 mg/kg bw/day

 

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