Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
DNEL value:
79 mg/m³
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation is considered appropriate as the substance is not expected different metabolic pathways (e.g. no first pass effects) based on route.
AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic study
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.3 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):
100
Modified dose descriptor starting point:
NOAEL
DNEL value:
432 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation is considered appropriate as the substance is not expected different metabolic pathways (e.g. no first pass effects) based on route.
AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
rat-to-human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
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:
1.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
DNEL value:
79 mg/m³
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation is considered appropriate as the substance is not expected different metabolic pathways (e.g. no first pass effects) based on route.
AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic study
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.2 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:
432 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation is considered appropriate as the substance is not expected different metabolic pathways (e.g. no first pass effects) based on route.
AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
rat-to-human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.23 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:
45 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation is considered appropriate as the substance is not expected different metabolic pathways (e.g. no first pass effects) based on route.
AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
rat-to-human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
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