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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:
10 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):
5
Modified dose descriptor starting point:
NOAEC
Value:
152 mg/m³
Explanation for the modification of the dose descriptor starting point:

Systemic effects

AF for dose response relationship:
1
Justification:
the NOAEL was at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic (2-year) study
AF for interspecies differences (allometric scaling):
1
Justification:
has already been done at the correction in sRV
AF for other interspecies differences:
1
Justification:
hardly absorbed and not metabolized
AF for intraspecies differences:
5
Justification:
standard assessment factor
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
10 mg/m³
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:
62 500 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):
20
Modified dose descriptor starting point:
NOAEL
Value:
1 250 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

systemic effects

AF for dose response relationship:
1
Justification:
NOAEL is at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
allomteric scaling
AF for other interspecies differences:
1
Justification:
hardly absorbed and not metabolized
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no 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:
2.5 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):
10
Modified dose descriptor starting point:
NOAEC
Value:
75 mg/m³
Explanation for the modification of the dose descriptor starting point:

systemic effects

AF for dose response relationship:
1
Justification:
NOAEL is at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
has already been done at the correction in sRV
AF for other interspecies differences:
1
Justification:
hardly absorbed and not metabolized
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no remaning 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:
31 250 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):
40
Modified dose descriptor starting point:
NOAEL
Value:
1 250 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

systemic effects

AF for dose response relationship:
1
Justification:
NOAEL at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling
AF for other interspecies differences:
1
Justification:
hardly absorbed and not metabolized
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no 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:
6.25 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):
40
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

systemic effects

AF for dose response relationship:
1
Justification:
NOAEL at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling
AF for other interspecies differences:
1
Justification:
remaining differences in case of systemic effects
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no reamining 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

See at justification and comments