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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:
0.14 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Value:
0.71 mg/m³
AF for dose response relationship:
1
Justification:
This factor is applied because the dose-descriptor starting point is a NOAEC.
AF for differences in duration of exposure:
1
Justification:
Local effects on the respiratory tract are related to the deposited dose per unit of surface area. Below a certain concentration the clearance capacity of the lungs is not overwhelmed and the lungs retain the ability to clear the deposited MWCNT. Therefore, the lung effects are not suspected to worsen with increasing exposure duration (from sub-acute to chronic).
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation.
AF for other interspecies differences:
1
Justification:
On the basis that inhalation exposure only produces local effects, an allometric scaling for interspecies variation was not performed. No additional assessment factor is added for interspecies extrapolation from rodent to human, since the respiratory rat of rats (0.29 m3/kg-day according to Pauluhn (2010)) leads to a greater lung tract burden as compared to humans (0.14 m3/kg-day); thus the effects observed in rat are exaggerated and provide a “built in” safety margin.
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
The key study is considered as a reliable study with a klimisch score of 1 and the database is complete and robust.
AF for remaining uncertainties:
1
Justification:
Not needed
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.26 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEC
Value:
1.3 mg/m³
AF for dose response relationship:
1
Justification:
This factor is applied because the dose-descriptor starting point is a NOAEC.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation.
AF for other interspecies differences:
1
Justification:
On the basis that inhalation exposure only produces local effects, an allometric scaling for interspecies variation was not performed. No additional assessment factor is added for interspecies extrapolation from rodent to human, since the respiratory rate of rats (0.29 m3/kg-day according to Pauluhn (2010)) leads to a greater lung tract burden as compared to humans (0.14 m3/kg-day) and the NOAEC is based on a total exposure of 30 hours; thus the effects observed in rats are exaggerated and provide a “built in” safety margin. 
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
The key study is considered as a reliable study with a klimisch score of 1 and the database is complete and robust.
AF for remaining uncertainties:
1
Justification:
Not needed

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

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:
DNEL (Derived No Effect Level)
Value:
0.025 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Value:
0.25 mg/m³
AF for dose response relationship:
1
Justification:
This factor is applied because the dose-descriptor starting point is a NOAEC.
AF for differences in duration of exposure:
1
Justification:
Local effects on the respiratory tract are related to the deposited dose per unit of surface area. Below a certain concentration the clearance capacity of the lungs is not overwhelmed and the lungs retain the ability to clear the deposited MWCNT. Therefore, the lung effects are not suspected to worsen with increasing exposure duration (from sub-acute to chronic).
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation.
AF for other interspecies differences:
10
Justification:
Default factor for general population
AF for intraspecies differences:
1
Justification:
On the basis that inhalation exposure only produces local effects, an allometric scaling for interspecies variation was not performed. No additional assessment factor is added for interspecies extrapolation from rodent to human, since the respiratory rate of rats (0.29 m3/kg-day according to Pauluhn (2010)) leads to a greater lung tract burden as compared to humans (0.14 m3/kg-day) and the NOAEC is based on a total exposure of 30 hours; thus the effects observed in rats are exaggerated and provide a “built in” safety margin. 
AF for the quality of the whole database:
1
Justification:
The key study is considered as a reliable study with a klimisch score of 1 and the database is complete and robust.
AF for remaining uncertainties:
1
Justification:
Not needed
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.13 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Value:
1.3 mg/m³
AF for dose response relationship:
1
Justification:
This factor is applied because the dose-descriptor starting point is a NOAEC.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation.
AF for other interspecies differences:
1
Justification:
On the basis that inhalation exposure only produces local effects, an allometric scaling for interspecies variation was not performed. No additional assessment factor is added for interspecies extrapolation from rodent to human, since the respiratory rate of rats (0.29 m3/kg-day according to Pauluhn (2010)) leads to a greater lung tract burden as compared to humans (0.14 m3/kg-day) and the NOAEC is based on a total exposure of 30 hours; thus the effects observed in rats are exaggerated and provide a “built in” safety margin. 
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
The key study is considered as a reliable study with a klimisch score of 1 and the database is complete and robust.
AF for remaining uncertainties:
1
Justification:
Not needed

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
low hazard (no threshold derived)

Additional information - General Population

According to the use and the exposure scenarii, no exposure of the general population is expected.