Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.55 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):
37.5
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
133 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for differences in duration of exposure:
3
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
5
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.65 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
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
133 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
5
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.87 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
NOAEC
Value:
133 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for differences in duration of exposure:
3
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA guidance
AF for other interspecies differences:
1
Justification:
Default ECHA guidance
AF for intraspecies differences:
5
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26.62 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEC
Value:
133 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA guidance
AF for other interspecies differences:
1
Justification:
Default ECHA guidance
AF for intraspecies differences:
5
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.01 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):
150
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for differences in duration of exposure:
3
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
5
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.02 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
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
5
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.52 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor:
NOAEC
Value:
133 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for differences in duration of exposure:
3
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
1
Justification:
Default ECHA guidance
AF for intraspecies differences:
5
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.55 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
NOAEC
Value:
133 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
1
Justification:
Default ECHA guidance
AF for intraspecies differences:
5
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance

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:
0.88 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):
75
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
65 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for differences in duration of exposure:
3
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.63 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
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
65 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.19 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor:
NOAEC
Value:
65 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for differences in duration of exposure:
3
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA guidance
AF for other interspecies differences:
1
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.57 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Value:
65 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA guidance
AF for other interspecies differences:
1
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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):
300
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for differences in duration of exposure:
3
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.51 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
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.26 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Dose descriptor:
NOAEC
Value:
65 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for differences in duration of exposure:
3
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
1
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.78 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEC
Value:
65 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
1
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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):
300
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for differences in duration of exposure:
3
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.51 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
Dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
151 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default ECHA guidance
AF for intraspecies differences:
10
Justification:
Default ECHA guidance
AF for the quality of the whole database:
1
Justification:
Default ECHA guidance
AF for remaining uncertainties:
1
Justification:
Default ECHA guidance

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population