Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.49 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
DNEL value:
8.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
oral to inhalation
AF for dose response relationship:
1
Justification:
Based on NOAEL
AF for differences in duration of exposure:
6
Justification:
Based on subacute study (chronic exposure worker assumed)
AF for interspecies differences (allometric scaling):
1
Justification:
No correction for caloric demand for inhalation, is included in dose descriptor starting point
AF for other interspecies differences:
1
Justification:
No additional factor
AF for intraspecies differences:
3
Justification:
Difference in sensitivity among workers
AF for the quality of the whole database:
1
Justification:
Reliable studies
AF for remaining uncertainties:
1
Justification:
Not applicable
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high 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:
0.14 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
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
DNEL value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not relevant
AF for dose response relationship:
1
Justification:
Based on NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
no additional factor
AF for intraspecies differences:
3
Justification:
Difference in sensitivity among workers
AF for the quality of the whole database:
1
Justification:
reliable studies
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.25 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
3
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Based on NOAEL
AF for differences in duration of exposure:
1
Justification:
Not relevant
AF for interspecies differences (allometric scaling):
1
Justification:
Not relevant for local effects
AF for other interspecies differences:
1
Justification:
No additional factor
AF for intraspecies differences:
3
Justification:
Difference in sensitivity among workers
AF for the quality of the whole database:
1
Justification:
reliable studies
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high 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:
0.29 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
DNEL value:
8.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
oral to inhalation
AF for dose response relationship:
1
Justification:
based on NOAEL
AF for differences in duration of exposure:
6
Justification:
Based on subacute study (chronic exposure worker assumed)
AF for interspecies differences (allometric scaling):
1
Justification:
No correction for caloric demand for inhalation, is included in dose descriptor starting point
AF for other interspecies differences:
1
Justification:
no additional factor
AF for intraspecies differences:
5
Justification:
Difference in sensitivity among population
AF for the quality of the whole database:
1
Justification:
reliable studies
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
83 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
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
DNEL value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not relevant
AF for dose response relationship:
1
Justification:
based on NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
no additional factor
AF for intraspecies differences:
5
Justification:
Difference in sensitivity among population
AF for the quality of the whole database:
1
Justification:
Reliable studies
AF for remaining uncertainties:
1
Justification:
Not applicable
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.75 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
5
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
based on NOAEL
AF for differences in duration of exposure:
1
Justification:
Not relevant
AF for interspecies differences (allometric scaling):
1
Justification:
Not relevant for local effect
AF for other interspecies differences:
1
Justification:
No additional factor
AF for intraspecies differences:
5
Justification:
Difference in sensitivity among population
AF for the quality of the whole database:
1
Justification:
Reliable studies
AF for remaining uncertainties:
1
Justification:
Not relevant
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
42 µg/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
DNEL value:
5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not relevant
AF for dose response relationship:
1
Justification:
based on NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
No additional factor
AF for intraspecies differences:
5
Justification:
Difference in sensitivity among population
AF for the quality of the whole database:
1
Justification:
reliable studies
AF for remaining uncertainties:
1
Justification:
noit applicable
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population