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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:
0.1 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
54
Modified dose descriptor starting point:
NOAEC
DNEL value:
5.36 mg/m³
Explanation for the modification of the dose descriptor starting point:
not applicable
AF for dose response relationship:
1
Justification:
the value is a NOAEL
AF for differences in duration of exposure:
18
Justification:
based on an acute study assuming chronic exposure of the worker
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand as starting point is an inhalation study
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
3
Justification:
difference is sensitivity among workers
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
3
Modified dose descriptor starting point:
NOAEC
DNEL value:
27 mg/m³
Explanation for the modification of the dose descriptor starting point:
not applicable
AF for dose response relationship:
1
Justification:
the value is a NOAEC
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand as starting point is an inhalation study
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
3
Justification:
difference is sensitivity among workers
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
3
Dose descriptor:
other: NOAEC of 0.12 mg/m3 for local effects
AF for dose response relationship:
1
Justification:
the value is a NOAEC
AF for differences in duration of exposure:
1
Justification:
for local effects
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand as starting point is an inhalation study
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
3
Justification:
difference is sensitivity among workers
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.3 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
3
Dose descriptor starting point:
other: NOAEC of 16 mg/m3 for local effects
AF for dose response relationship:
1
Justification:
the value is a NOAEC
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand as starting point is inhalation study
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
3
Justification:
difference is sensitivity among workers
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
DNEL value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
kinetics are considered to be similar for oral and dermal intake in the absence of evidence of the opposite
AF for dose response relationship:
1
Justification:
value is a NOAEL
AF for differences in duration of exposure:
6
Justification:
based on subacute study, assuming chronic exposure of the worker
AF for interspecies differences (allometric scaling):
4
Justification:
from rat to human
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
3
Justification:
difference is sensitivity among workers
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
90
Modified dose descriptor starting point:
NOAEC
DNEL value:
2.67 mg/m³
Explanation for the modification of the dose descriptor starting point:
not applicable
AF for dose response relationship:
1
Justification:
value is a NOAEC
AF for differences in duration of exposure:
18
Justification:
based on an acute study assuming chronic exposure of the general population
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand as starting point is an inhalation study
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
5
Justification:
difference is sensitivity among general population
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEC
DNEL value:
35 mg/m³
Explanation for the modification of the dose descriptor starting point:
not applicable
AF for dose response relationship:
1
Justification:
value is a NOAEC
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand as starting point is an inhalation study
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
5
Justification:
difference is sensitivity among general population
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.024 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
5
Dose descriptor:
other: NOAEC of 0.12 mg/m3 from a sub-chronic inhalationt toxicity study
AF for dose response relationship:
1
Justification:
value is a NOAEC
AF for differences in duration of exposure:
1
Justification:
local effects
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand as starting point is an inhalation study
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
5
Justification:
difference is sensitivity among general population
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.2 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: NOAEC of 16 mg/m3 from an acute inhalation study
AF for dose response relationship:
1
Justification:
value is a NOAEC
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand as starting point is an inhalation study
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
5
Justification:
difference is sensitivity among general population
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
DNEL value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral and dermal absorption are both 100%. Kinetics are considered to be similar for oral and dermal intake in the absence of evidence of the opposite.
AF for dose response relationship:
1
Justification:
value is a NOAEL
AF for differences in duration of exposure:
6
Justification:
from subacute to chronic, assuming chronic exposure of the general population
AF for interspecies differences (allometric scaling):
4
Justification:
from rat to human
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
5
Justification:
difference is sensitivity among general population
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance Technical Report No. 110, 2010
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
DNEL value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not applicable
AF for dose response relationship:
1
Justification:
value is a NOAEL
AF for differences in duration of exposure:
6
Justification:
from subacute to chronic, assuming chronic exposure of the general population
AF for interspecies differences (allometric scaling):
4
Justification:
from rat and human
AF for other interspecies differences:
1
Justification:
no additional factor required
AF for intraspecies differences:
5
Justification:
difference in sensitivity among general population
AF for the quality of the whole database:
1
Justification:
extensive data package with reliable studies
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population