Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
28.21 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
28.21 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70.53 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70.53 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:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor:
NOAEC
Value:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 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:
352 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

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:
6.96 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.96 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.39 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Value:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.39 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:
174 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
1
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for differences in duration of exposure:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA guidance assessment factors.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA guidance assessment factors.
AF for other interspecies differences:
2.5
Justification:
Standard ECHA guidance assessment factors.
AF for intraspecies differences:
10
Justification:
Standard ECHA guidance assessment factors.
AF for the quality of the whole database:
1
Justification:
Standard ECHA guidance assessment factors.
AF for remaining uncertainties:
1
Justification:
Standard ECHA guidance assessment factors.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population