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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
4.25 mg/m³
Explanation for the modification of the dose descriptor starting point:
toxicokinetic properties allow a route to route extrapolation
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
not required, chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
not required due to corrected starting point
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
worker, default value ECHA
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 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):
50
Modified dose descriptor starting point:
NOAEL
Value:
4.83 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The resoprtion after oral and dermal application is considered to comparable.
AF for dose response relationship:
1
Justification:
not required
AF for differences in duration of exposure:
1
Justification:
not required, chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> man
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
worker, default value ECHA
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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

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:
0.08 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
2.1 mg/m³
Explanation for the modification of the dose descriptor starting point:
toxicokinetic properties allow a route to route
AF for dose response relationship:
1
Justification:
not required
AF for differences in duration of exposure:
1
Justification:
not required
AF for interspecies differences (allometric scaling):
1
Justification:
not required due to corrected starting point
AF for other interspecies differences:
2.5
Justification:
default value ECHA
AF for intraspecies differences:
10
Justification:
default value for general pouplation
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.05 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
4.83 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
toxicokinetic properties allow a route to route
AF for dose response relationship:
1
Justification:
not required
AF for differences in duration of exposure:
1
Justification:
not required
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> man
AF for other interspecies differences:
2.5
Justification:
default value ECHA
AF for intraspecies differences:
10
Justification:
default value general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.05 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
4.83 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not required
AF for dose response relationship:
1
Justification:
not required
AF for differences in duration of exposure:
1
Justification:
not required
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> man
AF for other interspecies differences:
2.5
Justification:
default value ECHA
AF for intraspecies differences:
10
Justification:
default value general population
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