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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
24.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEC
Value:
440 mg/m³
Explanation for the modification of the dose descriptor starting point:
comparable systemic effects after exposure by inhaltion and by oral uptake expected
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required due to allometric scaling
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
3
Justification:
default value
AF for the quality of the whole database:
1
Justification:
high quality of database
AF for remaining uncertainties:
1
Justification:
not required
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:
3.47 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The bioavailability after oral exposure is higher than after dermal expsoure, hence the data from oral studies are considered to be worst case figures.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default value for extrapolation rat -> man
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
3
Justification:
default value for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
217 mg/m³
Explanation for the modification of the dose descriptor starting point:
comparable systemic effects after exposure by inhaltion and by oral uptake expected
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required due to allometric scaling
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
high quality of database
AF for remaining uncertainties:
1
Justification:
not required
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:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The bioavailability after oral exposure is higher than after dermal expsoure, hence the data from oral studies are considered to be worst case figures.
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default value for extrapolation rat -> man
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
high quality of database
AF for remaining uncertainties:
1
Justification:
not required
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:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute -> chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default value for extrapolation rat -> man
AF for other interspecies differences:
1
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
high quality of database
AF for remaining uncertainties:
1
Justification:
not required
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