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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.23 mg/m³
Most sensitive endpoint:
effect on fertility
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:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
17.62 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Oral NOAELrat × (1/0.38 m^3/kg bw) × (6.7 m^3/10m^3) × (50% /100%) = 20 × 2.63 × 0.67 × 0.5

Inhalation NOAEChuman = 17.62 mg/m^3

AF for dose response relationship:
1
Justification:
A NOAEC for systemic toxicity was derived
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable as inhalation DNEL
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Complete data set for the tonnage band
AF for remaining uncertainties:
2.5
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.7 mg/m³
DNEL related information
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
17.62 mg/m³
Explanation for the modification of the dose descriptor starting point:

DNEL derivation method: ECHA REACH Guidance

3x the long-term DNEL = 0.7 mg/m3

Local effects

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Dermal NOELrat× (50% / 50%) = 10 × 1

Dermal NOELhuman= 10 mg/kg bw/day

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is a 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:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Complete data set for the tonnage band
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:
high 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:
0.06 mg/m³
Most sensitive endpoint:
effect on fertility
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:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
8.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Oral NOAELrat × (1/1.15 m^3/kg bw) × (50% /100%) = 20 × 0.869 × 0.5

Inhalation NOAEChuman = 8.7 mg/m^3

AF for dose response relationship:
1
Justification:
A NOAEC for systemic toxicity was derived
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable as inhalation DNEL
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
10
Justification:
Default value for the general population
AF for the quality of the whole database:
1
Justification:
Complete data set for the tonnage band
AF for remaining uncertainties:
2.5
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 mg/m³
DNEL related information
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
0.06 mg/m³

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
0.017 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Dermal NOELrat× (50% / 50%) = 10 × 1

Dermal NOELhuman= 10 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A NOAEL was derived
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factor for the rat
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
10
Justification:
Default value for the general population
AF for the quality of the whole database:
1
Justification:
Complete data set for the tonnage band
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:
0.03 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):
600
Dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of starting point:

Oral NOAELrat × (50% / 50%) = 20  

Oral NOAELhuman = 20 mg/kg bw/day

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factor for the rat
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
10
Justification:
Default value for the general population
AF for the quality of the whole database:
1
Justification:
Complete data set for the tonnage band
AF for remaining uncertainties:
2.5
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.09 mg/kg bw/day
DNEL related information
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

DNEL derivation method: ECHA REACH Guidance

3x the long-term DNEL =0.09 mg/m^3

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

In an in vivo eye irritation study in rabbits, the substance caused serious eye damage and was classified as category 1 for eye effects. Therefore the substance is considered a medium hazard. No information on which to derive a threshold or minimal effect level is available.