Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEC
Value:
7 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
The substance is not bioavailable according to Lipinski rule. The phys-chem parameters indicate that the substance is not inhalable.
AF for dose response relationship:
1
Justification:
standard factor
AF for differences in duration of exposure:
6
Justification:
standard factor for the extrapolation of subacute studies
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor for rat -> man
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
5
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
study quality rating according to Klimisch is 1
AF for remaining uncertainties:
1
Justification:
standard factor
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
7 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
The phys-chem parameters indicate that the substance is not inhalable.
AF for dose response relationship:
1
Justification:
standard factor
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor for rat -> man
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
5
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
study quality rating according to Klimisch is 1
AF for remaining uncertainties:
0.2
Justification:
Extrapolation from subactue study to acute study

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:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The LD50 dermal is >2000 mg/kg, indicating absent / low dermal absorption or non-toxicity. The substance is also not bioavailable on the oral route according to Lipinski rule. The phys-chem parameters indicate that the substance is not inhalable.
AF for dose response relationship:
1
Justification:
standard factor
AF for differences in duration of exposure:
6
Justification:
standard factor for extrapolation subacute -> chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor for rat -> man
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
5
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
study quality rating according to Klimisch is 1
AF for remaining uncertainties:
1
Justification:
standard factor
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.83 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEC
Value:
3 500 mg/m³
Explanation for the modification of the dose descriptor starting point:
The substance is not bioavailable according to Lipinski rule. The phys-chem parameters indicate that the substance is not inhalable.
AF for dose response relationship:
1
Justification:
standard factor
AF for differences in duration of exposure:
6
Justification:
standard factor
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor
AF for other interspecies differences:
2.5
Justification:
standard factor
AF for intraspecies differences:
10
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
standard factor
AF for remaining uncertainties:
1
Justification:
standard factor
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:
low hazard (no threshold derived)
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:
no DNEL required: short term exposure controlled by conditions for long-term

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population