Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.63 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):
50
Dose descriptor starting point:
NOAEL
Value:
881 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for differences in duration of exposure:
4
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA 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
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:
881 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
44.08 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:
881 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for differences in duration of exposure:
4
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
176.32 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:
881 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.67 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):
150
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20.42 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:
881 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
61.25 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:
881 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA 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:
5.8 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):
75
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA 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
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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.49 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:
881 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.48 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:
881 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 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):
300
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.21 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:
881 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30.63 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:
881 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 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):
300
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.25 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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA Assessment Factors

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population