Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.29 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):
450
Dose descriptor starting point:
other: NOEL
Value:
73 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
128.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Oral NOELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (100% /100%) = 73 × 2.63 × 0.67 × 1

Inhalation NOEChuman= 128.6 mg/m3

AF for dose response relationship:
2
Justification:
QSAR predicted NOEL
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
NA for inhalation
AF for other interspecies differences:
1
Justification:
Addressed by modification of the starting dose
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
3
Justification:
QSAR prediction
AF for remaining uncertainties:
2.5
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.6 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):
1 800
Dose descriptor starting point:
other: NOEL
Value:
73 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
292 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Oral NOELrat× (100% /25%) = 73 × 4

Dermal NOELhuman= 292 mg/kg bw/day

AF for dose response relationship:
2
Justification:
QSAR predicted NOEL
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
5
Justification:
Defauly value for workers
AF for the quality of the whole database:
3
Justification:
QSAR prediction
AF for remaining uncertainties:
2.5
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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:
0.07 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):
900
Dose descriptor starting point:
other: NOEL
Value:
73 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
63.51 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Oral LOAELrat× (1/1.15 m3/kg bw) × (10% /100%) = 73 × 0.87 × 1

Inhalation NOEChuman= 63.51 mg/m3

AF for dose response relationship:
2
Justification:
QSAR predicted NOEL
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
NA for inhalation
AF for other interspecies differences:
1
Justification:
Addressed by modification to starting dose
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
3
Justification:
QSAR predictions
AF for remaining uncertainties:
2.5
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.08 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):
3 600
Dose descriptor starting point:
other: NOEL
Value:
73 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
292 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Oral NOELrat× (100% /25%) = 73 × 4

Dermal NOELhuman= 292 mg/kg bw/day

AF for dose response relationship:
2
Justification:
QSAR predicted NOEL
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting dose
AF for intraspecies differences:
10
Justification:
default value for general population
AF for the quality of the whole database:
3
Justification:
QSAR predictions
AF for remaining uncertainties:
2.5
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.02 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):
3 600
Dose descriptor starting point:
other: NOEL
Value:
73 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
73 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Oral NOELrat= Oral NOELhuman= 73

 Oral NOELhuman= 73 mg/kg bw/day

AF for dose response relationship:
2
Justification:
QSAR predicted NOEL
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting dose
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
3
Justification:
QSAR predictions
AF for remaining uncertainties:
2.5
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population