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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEC
Value:
440 mg/m³
Explanation for the modification of the dose descriptor starting point:
comparable systemic effects after exposure by inhaltion and by oral uptake expected
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required due to allometric scaling
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
3
Justification:
default value
AF for the quality of the whole database:
1
Justification:
high quality of database
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.47 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The bioavailability after oral exposure is higher than after dermal expsoure, hence the data from oral studies are considered to be worst case figures.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default value for extrapolation rat -> man
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
3
Justification:
default value for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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:
7.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
217 mg/m³
Explanation for the modification of the dose descriptor starting point:
comparable systemic effects after exposure by inhaltion and by oral uptake expected
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required due to allometric scaling
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
high quality of database
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local 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 via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The bioavailability after oral exposure is higher than after dermal expsoure, hence the data from oral studies are considered to be worst case figures.
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default value for extrapolation rat -> man
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
high quality of database
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default value for extrapolation rat -> man
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
high quality of database
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population