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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DMEL (Derived Minimum Effect Level)
Value:
0.15 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
9.19 mg/m³
Explanation for the modification of the dose descriptor starting point:
n.a., no route extrapolation
AF for dose response relationship:
1
Justification:
default factor
AF for differences in duration of exposure:
6
Justification:
default factor for subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation
AF for other interspecies differences:
1
Justification:
not required for inhalation
AF for intraspecies differences:
5
Justification:
default value worker
AF for the quality of the whole database:
1
Justification:
default factor
AF for remaining uncertainties:
1
Justification:
default factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.01 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
default factor LOAEL
AF for differences in duration of exposure:
6
Justification:
default factor for subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation
AF for other interspecies differences:
1
Justification:
not required for inhalation
AF for intraspecies differences:
5
Justification:
default factor worker
AF for the quality of the whole database:
1
Justification:
default factor
AF for remaining uncertainties:
1
Justification:
default factor
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:
no hazard identified
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.01 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
450
Modified dose descriptor starting point:
NOAEC
Value:
9.19 mg/m³
Explanation for the modification of the dose descriptor starting point:
n.a. no route extrapolationb
AF for dose response relationship:
1
Justification:
default factor
AF for differences in duration of exposure:
6
Justification:
default factor subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation
AF for other interspecies differences:
1
Justification:
not required for inhalation
AF for intraspecies differences:
10
Justification:
default factor public
AF for the quality of the whole database:
1
Justification:
default factor
AF for remaining uncertainties:
1
Justification:
default factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.005 ng/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
default LOAEC
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
hot required for local
AF for other interspecies differences:
1
Justification:
hot required for local
AF for intraspecies differences:
10
Justification:
public
AF for the quality of the whole database:
1
Justification:
default factor
AF for remaining uncertainties:
1
Justification:
default factor
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:
no hazard identified
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:
DMEL (Derived Minimum Effect Level)
Value:
0.45 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
51.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not relevant, oraö tp oral
AF for dose response relationship:
1
Justification:
Default factor
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometic scaling factor
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
10
Justification:
public
AF for the quality of the whole database:
1
Justification:
default factor
AF for remaining uncertainties:
1
Justification:
default factor
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