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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:
2.03 mg/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):
25
Modified dose descriptor starting point:
NOAEC
DNEL value:
50.8 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC is used as starting point
AF for differences in duration of exposure:
2
Justification:
default AF for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
5
Justification:
default AF 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:
DNEL (Derived No Effect Level)
Value:
0.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
NOAEC is used as starting point
AF for differences in duration of exposure:
2
Justification:
default AF for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
5
Justification:
default AF 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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.056 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Modified dose descriptor starting point:
NOAEL
DNEL value:
10 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default AF for use of NOAEL as starting point
AF for differences in duration of exposure:
6
Justification:
default AF for subacute to chronic
AF for interspecies differences (allometric scaling):
2.4
Justification:
allometric scaling factor for rabbit
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
5
Justification:
default AF 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:
DNEL (Derived No Effect Level)
Value:
0.001 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
other: NOAEL
AF for dose response relationship:
5
Justification:
LOAEL as starting point. Edema, atonia and desquamation were observed at lowest dose.
AF for differences in duration of exposure:
2
Justification:
Most effects visible in 3rd week of treatment where already visibile in the 2nd week
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling applied
AF for other interspecies differences:
1
AF for intraspecies differences:
5
Justification:
default AF 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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The DNELs were derived in accordance with the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.051 mg/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):
50
Modified dose descriptor starting point:
NOAEC
DNEL value:
10.1 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC used as starting point
AF for differences in duration of exposure:
2
Justification:
default factor sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for the general population
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:
DNEL (Derived No Effect Level)
Value:
0.51 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
NOAEC is used as starting point
AF for differences in duration of exposure:
2
Justification:
default AF for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for the general population
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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.028 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
360
Modified dose descriptor starting point:
NOAEL
DNEL value:
10 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default AF for NOAEL
AF for differences in duration of exposure:
6
Justification:
default AF for subacute to chronic
AF for interspecies differences (allometric scaling):
2.4
Justification:
allometric scaling factor for rabbit
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for general population
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:
DNEL (Derived No Effect Level)
Value:
0.001 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor:
other: LOAEL
AF for dose response relationship:
5
Justification:
LOAEL as starting point. Edema, atonia and desquamation were observed at lowest dose.
AF for differences in duration of exposure:
2
Justification:
Most effects visible in 3rd week of treatment where already visibile in the 2nd week
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
1
AF for intraspecies differences:
10
Justification:
default AF for general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.54 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
107.5 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default AF when NOAEL is used as starting point DNEL calculation
AF for differences in duration of exposure:
2
Justification:
default AF for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for general population
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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The DNELs were derived in accordance with the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8.