Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.7 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
Dose descriptor starting point:
NOAEL
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
616.7 mg/m³
AF for dose response relationship:
1
Justification:
starting point is a NOAEC
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
implicitly included in the corrected starting point
AF for other interspecies differences:
2.5
Justification:
toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
good quality and reliability
AF for remaining uncertainties:
1
Justification:
no significative remaining uncertainties
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:
7 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
Dose descriptor starting point:
NOAEL
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
700 mg/kg bw/day
AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default value
AF for other interspecies differences:
2.5
Justification:
toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
good quality and reliability
AF for remaining uncertainties:
1
Justification:
no significative remaining uncertainties
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:
3.7 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
Dose descriptor starting point:
NOAEL
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
185 mg/m³
AF for dose response relationship:
1
Justification:
starting point is a NOAEC
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
implicitly included in the corrected starting point
AF for other interspecies differences:
2.5
Justification:
toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
good quality and reliability
AF for remaining uncertainties:
1
Justification:
no significative remaining uncertainties.
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:
2.5 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
Dose descriptor starting point:
NOAEL
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
starting dose is a NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation form subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value
AF for other interspecies differences:
2.5
Justification:
toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
good quality and reliability
AF for remaining uncertainties:
1
Justification:
no significative remaining uncertainties
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:
2.5 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):
200
Dose descriptor starting point:
NOAEL
DNEL value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
starting dose is a NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation for subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value
AF for other interspecies differences:
2.5
Justification:
toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part).
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
good quality and reliability
AF for remaining uncertainties:
1
Justification:
no significative remaining uncertainties
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