Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.29 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):
50
Modified dose descriptor starting point:
NOAEC
Value:
264.5 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
2
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.58 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:
264.5 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
10
Justification:
Default ECHA assessment

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.22 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor:
NOAEC
Value:
264.5 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
2
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26.45 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:
264.5 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
2
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 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:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.75 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Dose descriptor:
NOAEC
Value:
264.5 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
2
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 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:
264.5 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

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:
1.3 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):
100
Modified dose descriptor starting point:
NOAEC
Value:
130.43 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
2
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.61 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):
50
Modified dose descriptor starting point:
NOAEC
Value:
130.43 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.26 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor:
NOAEC
Value:
130.43 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
2
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.52 mg/m³
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:
130.43 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.75 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):
400
Modified dose descriptor starting point:
NOAEL
Value:
130.43 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
2
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
130.43 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.88 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
160
Dose descriptor:
NOAEC
Value:
130.43 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
2
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.75 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Dose descriptor starting point:
NOAEC
Value:
130.43 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.75 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):
400
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
2
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population