Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 347 µg/m³
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14 694 µg/m³
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 347 µg/m³
DNEL related information
Overall assessment factor (AF):
60
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 347 µg/m³
DNEL related information
Overall assessment factor (AF):
60
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 333 µg/kg bw/day
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16 666 µg/kg bw/day
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 388 µg/cm²
DNEL related information
Overall assessment factor (AF):
60
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 388 µg/cm²
DNEL related information
Overall assessment factor (AF):
60
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Additional information - workers

All the DNELs values were derived starting from the OECD 421 combined repro study in rodent where a clear NOAEL (500 mg(kg/day) was determined by oral administration of the substance at fixed doses of 250, 500 and 1000 mg/kg/day. This reference NOAEL was selected as the lowest one. Those observed in the 28-day study after dietary administration of the substance were 831 and 963 mg/kg bw/day for male and female respectively. Inhalation and dermal systemic DNELs were calculated adopting a route to route extrapolation assessment considering differences in the absorption rate by oral rat and inhalation humans. Concerning the DNELdermal local we considered as starting point the calculation done on the basis of the data from the irritation study by skin application as the worst case approach.

DNELacute where also calculated in order to evaluate possible peak exposures (short exposure of 15 minutes) in particular for inhalation and dermal effects where. A factor of 2 was applied to the NOAELoral and deemed enough conservative.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 812 µg/m³
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 623 µg/m³
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 812 µg/m³
DNEL related information
Overall assessment factor (AF):
120
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 812 µg/m³
DNEL related information
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEC

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 167 µg/kg bw/day
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 333 µg/kg bw/day
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
694 µg/cm²
DNEL related information
Overall assessment factor (AF):
120
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
694 µg/cm²
DNEL related information
Overall assessment factor (AF):
120
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 167 µg/kg bw/day
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 333 µg/kg bw/day
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

All the DNELs values were derived starting from the OECD 421 combined repro study in rodent where a clear NOAEL (500 mg(kg/day) was determined by oral administration of the substance at fixed doses of 250, 500 and 1000 mg/kg/day. This reference NOAEL was selected as the lowest one. Those observed in the 28-day study after dietary administration of the substance were 831 and 963 mg/kg bw/day for male and female respectively. Inhalation and dermal systemic DNELs were calculated adopting a route to route extrapolation assessment considering differences in the absorption rate by oral rat and inhalation humans. Concerning the DNELdermal local we considered as starting point the calculation done on the basis of the data from the irritation study by skin application as the worst case approach.

DNELacute where also calculated in order to evaluate possible peak exposures (short exposure of 15 minutes) in particular for inhalation and dermal effects where. A factor of 2 was applied to the NOAELoral and deemed enough conservative.