Registration Dossier
Registration Dossier
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EC number: 247-304-1 | CAS number: 25869-00-5
Toxicological Summary
Administrative data
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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