Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26 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):
75
Modified dose descriptor starting point:
NOAEC
DNEL value:
1 952 mg/m³
AF for dose response relationship:
1
Justification:
default AF; clear NOAEL
AF for differences in duration of exposure:
6
Justification:
default AF for sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
no difference in metabolic rate (inhalation)
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
default AF for workers
AF for the quality of the whole database:
1
Justification:
default AF; GLP study
AF for remaining uncertainties:
1
Justification:
default AF; no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 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):
300
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default AF; clear NOAEL
AF for differences in duration of exposure:
6
Justification:
default AF for sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
differences in metabolic rate (rat/human)
AF for other interspecies differences:
2.5
Justification:
default for remaining differences
AF for intraspecies differences:
5
Justification:
default AF for workers
AF for the quality of the whole database:
1
Justification:
default AF; GLP study
AF for remaining uncertainties:
1
Justification:
default; no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

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:
6.48 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):
150
Modified dose descriptor starting point:
NOAEC
DNEL value:
972 mg/m³
AF for dose response relationship:
1
Justification:
default AF; clear NOAEL
AF for differences in duration of exposure:
6
Justification:
default AF for sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
no difference in metabolic rate (inhalation)
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
default AF for general population
AF for the quality of the whole database:
1
Justification:
default AF; GLP study
AF for remaining uncertainties:
1
Justification:
default AF; no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 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):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default AF; clear NOAEL
AF for differences in duration of exposure:
6
Justification:
default AF for sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
differences in metabolic rate (rat/human)
AF for other interspecies differences:
2.5
Justification:
default for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for general population
AF for the quality of the whole database:
1
Justification:
default AF; GLP study
AF for remaining uncertainties:
1
Justification:
default; no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 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):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default AF; clear NOAEL
AF for differences in duration of exposure:
6
Justification:
default AF for sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
differences in metabolic rate (rat/human)
AF for other interspecies differences:
2.5
Justification:
default for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for workers
AF for the quality of the whole database:
1
Justification:
default AF; GLP study
AF for remaining uncertainties:
1
Justification:
default; no 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