Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
27.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEC
Value:
502.3 mg/m³
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for other interspecies differences:
1
Justification:
AF for interspecies differences is not required for inhalation
AF for intraspecies differences:
3
Justification:
intraspecies differences for workers
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:
167.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
3
Dose descriptor:
NOAEC
AF for differences in duration of exposure:
1
Justification:
subacute to chronic - local effects
AF for other interspecies differences:
1
Justification:
AF for interspecies differences is not required for inhalation
AF for intraspecies differences:
3
Justification:
intraspecies differences for workers
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:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
24
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
For route to route extrapolation an assessment factor of 1 is taken into account as no information on dermal absorption is available.
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for other interspecies differences:
4
Justification:
interspecies difference for rat
AF for intraspecies differences:
3
Justification:
intraspecies differences for workers
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.33 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
250 mg/m³
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for other interspecies differences:
1
Justification:
interspecies differences are not relevant for inhalation
AF for intraspecies differences:
5
Justification:
differences for the general public
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:
50 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
AF for differences in duration of exposure:
1
Justification:
subacute to chronic - local effects
AF for other interspecies differences:
1
Justification:
interspecies differences are not relevant for inhalation
AF for intraspecies differences:
5
Justification:
differences for the general public
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:
3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
For route to route extrapolation an assessment factor of 1 is taken into account as no information on dermal absorption is available.
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for other interspecies differences:
4
Justification:
interspecies differences for rat
AF for intraspecies differences:
5
Justification:
intraspecies differences for general population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for other interspecies differences:
4
Justification:
interspecies differences for rat
AF for intraspecies differences:
5
Justification:
intraspecies differences for general population
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