Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.4 mg/m³
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
540
Modified dose descriptor starting point:
other: LC50
Value:
5 090 mg/m³
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
No effects observed at the highest dose tested.
AF for differences in duration of exposure:
18
Justification:
Assuming chronic exposure of the worker.
AF for interspecies differences (allometric scaling):
1
Justification:
No correction for caloric demand for inhalation.
AF for other interspecies differences:
1
Justification:
Not needed.
AF for intraspecies differences:
3
Justification:
Difference in sensitivity among workers.
AF for the quality of the whole database:
10
Justification:
No repeated dose data 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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.93 mg/kg bw/day
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
2 160
Modified dose descriptor starting point:
other: LD50
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
No effects observed at the highest dose tested.
AF for differences in duration of exposure:
18
Justification:
Assuming chronic exposure of the worker.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to human.
AF for other interspecies differences:
1
Justification:
Not needed.
AF for intraspecies differences:
3
Justification:
Difference in sensitivity among workers.
AF for the quality of the whole database:
10
Justification:
No repeated dose data 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

See the CSR for more details.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.7 mg/m³
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
900
Modified dose descriptor starting point:
other: LC50
Value:
5 090 mg/m³
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
No effects observed at the highest dose tested.
AF for differences in duration of exposure:
18
Justification:
Assuming chronic exposure of the worker.
AF for interspecies differences (allometric scaling):
1
Justification:
No correction for caloric demand for inhalation.
AF for other interspecies differences:
1
Justification:
Not needed.
AF for intraspecies differences:
5
Justification:
Difference in sensitivity among individuals.
AF for the quality of the whole database:
10
Justification:
No repeated dose data 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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.56 mg/kg bw/day
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
3 600
Modified dose descriptor starting point:
other: LD50
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
No effects observed at the highest dose tested.
AF for differences in duration of exposure:
18
Justification:
Assuming chronic exposure of the worker.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to human.
AF for other interspecies differences:
1
Justification:
Not needed.
AF for intraspecies differences:
5
Justification:
Difference in sensitivity among individuals.
AF for the quality of the whole database:
10
Justification:
No repeated dose data 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:
0.56 mg/kg bw/day
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
3 600
Modified dose descriptor starting point:
other: LD50
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
No effects observed at the highest dose tested.
AF for differences in duration of exposure:
18
Justification:
Assuming chronic exposure of the worker.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to human.
AF for other interspecies differences:
1
Justification:
Not needed.
AF for intraspecies differences:
5
Justification:
Difference in sensitivity among individuals.
AF for the quality of the whole database:
10
Justification:
No repeated dose data available.
AF for remaining uncertainties:
1
Justification:
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

See the CSR for more details.