Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 450 000 µg/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
AF for dose response relationship:
1
Justification:
standard assessment factor
AF for differences in duration of exposure:
6
Justification:
standard assessment factor
AF for interspecies differences (allometric scaling):
1
Justification:
standard assessment factor
AF for other interspecies differences:
1
Justification:
standard assessment factor
AF for intraspecies differences:
5
Justification:
standard assessment factor
AF for the quality of the whole database:
1
Justification:
standard assessment factor
AF for remaining uncertainties:
1
Justification:
not present
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
225 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
AF for dose response relationship:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
4
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
5
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.268 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
AF for dose response relationship:
1
Justification:
standard default
AF for differences in duration of exposure:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
1
Justification:
standard default
AF for other interspecies differences:
5
Justification:
standard default
AF for intraspecies differences:
1
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
AF for dose response relationship:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
1
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
5
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
AF for dose response relationship:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
4
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
5
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
400 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
AF for dose response relationship:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
1
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
5
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default

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:
0.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
AF for dose response relationship:
1
Justification:
standard default
AF for differences in duration of exposure:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
1
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
10
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.112 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
AF for dose response relationship:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
4
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
10
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
AF for dose response relationship:
1
Justification:
standard default
AF for differences in duration of exposure:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
1
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
10
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.45 mg/m³
DNEL related information
Overall assessment factor (AF):
10
AF for dose response relationship:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
1
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
10
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
Overall assessment factor (AF):
40
AF for dose response relationship:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
4
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
10
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
200 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
10
AF for dose response relationship:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
1
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
10
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
37.5 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
40
AF for dose response relationship:
1
Justification:
standard default
AF for interspecies differences (allometric scaling):
4
Justification:
standard default
AF for other interspecies differences:
1
Justification:
standard default
AF for intraspecies differences:
10
Justification:
standard default
AF for the quality of the whole database:
1
Justification:
standard default
AF for remaining uncertainties:
1
Justification:
standard default

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population