Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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):
75
Modified dose descriptor starting point:
NOAEC
DNEL value:
525 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to ECHA REACH Guidance

AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute-> chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Still covered by route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
Default value for workers.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
333 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
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
DNEL value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

see comments

AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute -> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> human
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
According to ECHA REACH Guidance for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.75 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:
262.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to ECHA REACH Guidance

AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute-> chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Still covered by route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
According to ECHA REACH Guidance for general population.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
166 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:
100 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

see comments

AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute-> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> human
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
According to ECHA REACH Guidance for general population.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
0.5 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):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
According to ECHA REACH Guidance
AF for differences in duration of exposure:
6
Justification:
subacute-> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> human
AF for other interspecies differences:
2.5
Justification:
According to ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
According to ECHA REACH Guidance: Default value for general population.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
low hazard (no threshold derived)

Additional information - General Population