Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
101 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: as proposed by ECETOC Technical Report #86.
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
612 mg/m³
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
2
Justification:
default for sub-chronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
No factor required for inhalation route of exposure
AF for other interspecies differences:
1
Justification:
as proposed by ECETOC Technical Report #86.
AF for intraspecies differences:
3
Justification:
as proposed by ECETOC Technical Report #86.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
402 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: See description below
Overall assessment factor (AF):
3
Modified dose descriptor starting point:
NOAEC
1 225
AF for dose response relationship:
1
Justification:
default
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation route of exposure
AF for other interspecies differences:
1
Justification:
as proposed by ECETOC Technical Report #86.
AF for intraspecies differences:
3
Justification:
as proposed by ECETOC Technical Report #86.
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
default

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
119 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: See description below. Read across from another substance using human volunteer data.
Overall assessment factor (AF):
1
Dose descriptor:
NOAEC
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)
364 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: see information below
Overall assessment factor (AF):
24
Modified dose descriptor starting point:
NOAEL
8 740 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
see detailed description below
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
2
Justification:
default for sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat to human extrapolation
AF for other interspecies differences:
1
Justification:
as proposed by ECETOC Technical Report #86.
AF for intraspecies differences:
3
Justification:
as proposed by ECETOC Technical Report #86.
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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)

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)
30 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: See details below
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
306 mg/m³
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
2
Justification:
default for sub-chronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation route of exposure
AF for other interspecies differences:
1
Justification:
as proposed by ECETOC Technical Report #86.
AF for intraspecies differences:
5
Justification:
as proposed by ECETOC Technical Report #86.
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
241 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: See description below
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEC
1 225 mg/m³
AF for dose response relationship:
1
Justification:
default
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation route of exposur
AF for other interspecies differences:
1
Justification:
default intraspecies factor for general population proposed by ECETOC Technical Report #86.
AF for intraspecies differences:
5
Justification:
default intraspecies factor for general population proposed by ECETOC Technical Report #86.
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
default

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
72 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: See justification and comments below.
Overall assessment factor (AF):
1.7
Dose descriptor:
NOAEC
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)
218 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: See comments below
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
8 740 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See detailed discussion below
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
2
Justification:
default for sub-chronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat to human extrapolation
AF for other interspecies differences:
1
Justification:
as proposed in the ECETOC Technical Report #86.
AF for intraspecies differences:
5
Justification:
as proposed in the ECETOC Technical Report #86.
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
6
Justification:
default for sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat to human extrapolation
AF for other interspecies differences:
1
Justification:
as proposed by ECETOC Technical Report #86.
AF for intraspecies differences:
5
Justification:
as proposed by ECETOC Technical Report #86.
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
default
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