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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:
0.371 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):
225
Dose descriptor starting point:
LOAEL
Value:
94.7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
83.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral LOAELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (50% /100%) = 94.7 × 2.63 × 0.67 × 0.5

Inhalation LOAEChuman= 83.5mg/m3

AF for dose response relationship:
3
Justification:
Extrapolation from LOAEL to NOAEL
AF for differences in duration of exposure:
2
Justification:
Default value - subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation
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:
3
Justification:
Prediction based on QSAR
AF for remaining uncertainties:
2.5
Justification:
Default value for systemic effects
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:
DNEL (Derived No Effect Level)
Value:
0.526 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):
900
Dose descriptor starting point:
LOAEL
Value:
94.7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
473.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral LOAELrat× (50% / 10%) = 94.7 × 5 = Dermal LOAELhuman= 473.5 mg/kg bw/day

AF for dose response relationship:
3
Justification:
Extrapolation from LOAEL to NOAEL
AF for differences in duration of exposure:
2
Justification:
Default value - subchronic 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:
3
Justification:
Prediction based on QSAR
AF for remaining uncertainties:
2.5
Justification:
Default value for systemic effects
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

No DNELs have been derived for general population as exposure does not occur during the lifecycle of the substance.

The substance is not used by consumers or professionals and only has manufacture, formulation and industrial uses.

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