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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
8.167 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):
120
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
no data available
AF for differences in duration of exposure:
6
Justification:
according to ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor
AF for other interspecies differences:
1
Justification:
no data available
AF for intraspecies differences:
5
Justification:
according to ECHA TGD
AF for the quality of the whole database:
1
Justification:
no data available
AF for remaining uncertainties:
1
Justification:
no data available
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.167 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):
120
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
no data available
AF for differences in duration of exposure:
6
Justification:
according to ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling
AF for other interspecies differences:
1
Justification:
no data available
AF for intraspecies differences:
5
Justification:
according to ECHA TGD
AF for the quality of the whole database:
1
Justification:
no data available
AF for remaining uncertainties:
1
Justification:
no data available
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)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.458 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):
240
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
no data available
AF for differences in duration of exposure:
6
Justification:
according to ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling
AF for other interspecies differences:
1
Justification:
no data available
AF for intraspecies differences:
10
Justification:
according to ECHA TGD
AF for the quality of the whole database:
1
Justification:
no data available
AF for remaining uncertainties:
1
Justification:
no data available
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.417 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):
240
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
no data available
AF for differences in duration of exposure:
6
Justification:
according to ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling
AF for other interspecies differences:
1
Justification:
no data available
AF for intraspecies differences:
10
Justification:
according to ECHA TGD
AF for the quality of the whole database:
1
Justification:
no data available
AF for remaining uncertainties:
1
Justification:
no data available
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.417 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):
240
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
no data available
AF for differences in duration of exposure:
6
Justification:
according to ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling
AF for other interspecies differences:
1
Justification:
no data available
AF for intraspecies differences:
10
Justification:
according to ECHA TGD
AF for the quality of the whole database:
1
Justification:
no data available
AF for remaining uncertainties:
1
Justification:
no data available
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population