Registration Dossier

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