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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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
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
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
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
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
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
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