Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEC
Value:
176 mg/m³
Explanation for the modification of the dose descriptor starting point:
No specific metabolism expected, thus oral to inhalation extrapolation based on absorption, which is considered 100% for both routes of exposure.
AF for dose response relationship:
1
Justification:
liver effects at LOAEL, no mortality
AF for differences in duration of exposure:
6
Justification:
extrapolation from subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand for inhalation
AF for other interspecies differences:
1
Justification:
according to ECETOC guidance
AF for intraspecies differences:
3
Justification:
standard factor for workers (ECETOC)
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
no factor is applied for the uncertainties in genotoxicity, the DNEL is provisional
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:
1.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No specific metabolism expected, thus oral to dermal extrapolation based on absorption, which is considered 100% for both routes of exposure.
AF for dose response relationship:
1
Justification:
liver effects at LOAEL, no mortality
AF for differences in duration of exposure:
6
Justification:
extrapolation from subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
correction for differences in allometric scaling between rat and human
AF for other interspecies differences:
1
Justification:
according to ECETOC guidance
AF for intraspecies differences:
3
Justification:
according to ECETOC guidance
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
no factor is applied for the uncertainties in genotoxicity; the DNEL is provisional.
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

To protect for corrosion effects to eyes, specific personal protection equipment will be prescribed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
87 mg/m³
Explanation for the modification of the dose descriptor starting point:
No specific metabolism expected, thus oral to inhalation extrapolation based on absorption, which is considered 100% for both routes of exposure.
AF for dose response relationship:
1
Justification:
liver effects at LOAEL, no mortality
AF for differences in duration of exposure:
6
Justification:
extrapolation from subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand for inhalation
AF for other interspecies differences:
1
Justification:
according to ECETOC guidance
AF for intraspecies differences:
5
Justification:
standard factor for workers (ECETOC)
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
no factor is applied for the uncertainties in genotoxicity; The DNEL is provisional
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:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No specific metabolism expected, thus oral to dermal extrapolation based on absorption, which is considered 100% for both routes of exposure.
AF for dose response relationship:
1
Justification:
liver effects at LOAEL, no mortality
AF for differences in duration of exposure:
6
Justification:
extrapolation from subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
correction for differences in allometric scaling between rat and human
AF for other interspecies differences:
1
Justification:
according to ECETOC guidance
AF for intraspecies differences:
5
Justification:
according to ECETOC guidance
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
no factor is applied for the uncertainties in genotoxicity. The DNEL is provisional.
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:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not relevant
AF for dose response relationship:
1
Justification:
relevant route tested
AF for differences in duration of exposure:
6
Justification:
extrapolation from subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
correction for differences in allometric scaling between rat and human
AF for other interspecies differences:
1
Justification:
according to ECETOC guidance
AF for intraspecies differences:
5
Justification:
differences within the general population
AF for the quality of the whole database:
1
Justification:
whole database is of good quality
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

To protect for corrosion effects to eyes, specific personal protection equipment will be prescribed.