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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18.06 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:
451.4 mg/m³
Explanation for the modification of the dose descriptor starting point:
The dose descriptor is corrected using the equations detailed in Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose[concentration]-response for human health. Figure R.8-3.

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AF for dose response relationship:
1
Justification:
Starting point for DNEL calculation is a NOAEL and dose spacing is considered acceptable so a default value of 1 is used.
AF for differences in duration of exposure:
1
Justification:
Chronic study is used, differences in duration of exposure do not need to be accounted for.
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling required because route to route extrapolation (oral to inhalation) takes this into account
AF for other interspecies differences:
2.5
Justification:
Default value used
AF for intraspecies differences:
5
Justification:
Default value for workers used
AF for the quality of the whole database:
2
Justification:
Modified to 2 to account for read across
AF for remaining uncertainties:
1
Justification:
Default value used
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
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:
4.45 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:
222.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
The dose descriptor is corrected using the equations detailed in Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose[concentration]-response for human health. Figure R.8-3.
AF for dose response relationship:
1
Justification:
Starting point for DNEL calculation is a NOAEL and dose spacing is considered acceptable so a default value of 1 is used.
AF for differences in duration of exposure:
1
Justification:
Chronic study is used, differences in duration of exposure do not need to be accounted for.
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling required because route to route extrapolation (oral to inhalation) takes this into account
AF for other interspecies differences:
2.5
Justification:
Default value used
AF for intraspecies differences:
10
Justification:
Default value for general population used
AF for the quality of the whole database:
2
Justification:
Modified to 2 to account for read across
AF for remaining uncertainties:
1
Justification:
Default value used
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
1.28 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:
256 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation not required.
AF for dose response relationship:
1
Justification:
Starting point for DNEL calculation is a LOAEL and dose spacing is considered acceptable so a default value of 1 is used.
AF for differences in duration of exposure:
1
Justification:
a chronic study is used, differences in duration of exposure do not need to be accounted for.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factor of 4 used to cover interspecies differences between rats and humans
AF for other interspecies differences:
2.5
Justification:
Default value used
AF for intraspecies differences:
10
Justification:
Default value for general population used
AF for the quality of the whole database:
2
Justification:
Modified to 2 to account for read across
AF for remaining uncertainties:
1
Justification:
Default value used
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population