Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.