Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
DNEL value:
181.9 mg/m³
Explanation for the modification of the dose descriptor starting point:
not required
AF for dose response relationship:
1
Justification:
NOAEC used as starting point
AF for differences in duration of exposure:
6
Justification:
standard factor for subacute to chronic, conservative considering exposure for 52 days.
AF for interspecies differences (allometric scaling):
1
Justification:
not required
AF for other interspecies differences:
1
Justification:
Leading effect is local irritation, for which no further difference in addition to those based on respiration volume and exposure time are expected. Rather, irritation is expected to be worse in rats as obligate nasal breathers. Additionally, a conservative approach was already chosen for time extrapolation.
AF for intraspecies differences:
5
Justification:
default value
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
LOAEC used as starting point
AF for differences in duration of exposure:
1
Justification:
effects observed after 52 days were minimal even at the mid dose
AF for interspecies differences (allometric scaling):
1
Justification:
not required
AF for other interspecies differences:
1
Justification:
Irritation is expected to be worse in rats as obligate nasal breathers.
AF for intraspecies differences:
5
Justification:
Default factor
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population