Registration Dossier
Registration Dossier
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EC number: 500-655-7 | CAS number: 161308-15-2
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.3 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):
- 300
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 7 000 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The substance is not bioavailable according to Lipinski rule. The phys-chem parameters indicate that the substance is not inhalable.
- AF for dose response relationship:
- 1
- Justification:
- standard factor
- AF for differences in duration of exposure:
- 6
- Justification:
- standard factor for the extrapolation of subacute studies
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor for rat -> man
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 5
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- study quality rating according to Klimisch is 1
- AF for remaining uncertainties:
- 1
- Justification:
- standard factor
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 700 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):
- 10
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 7 000 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The phys-chem parameters indicate that the substance is not inhalable.
- AF for dose response relationship:
- 1
- Justification:
- standard factor
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor for rat -> man
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 5
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- study quality rating according to Klimisch is 1
- AF for remaining uncertainties:
- 0.2
- Justification:
- Extrapolation from subactue study to acute study
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low 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:
- 3.33 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The LD50 dermal is >2000 mg/kg, indicating absent / low dermal absorption or non-toxicity. The substance is also not bioavailable on the oral route according to Lipinski rule. The phys-chem parameters indicate that the substance is not inhalable.
- AF for dose response relationship:
- 1
- Justification:
- standard factor
- AF for differences in duration of exposure:
- 6
- Justification:
- standard factor for extrapolation subacute -> chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor for rat -> man
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 5
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- study quality rating according to Klimisch is 1
- AF for remaining uncertainties:
- 1
- Justification:
- standard factor
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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:
- 5.83 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):
- 600
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 500 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The substance is not bioavailable according to Lipinski rule. The phys-chem parameters indicate that the substance is not inhalable.
- AF for dose response relationship:
- 1
- Justification:
- standard factor
- AF for differences in duration of exposure:
- 6
- Justification:
- standard factor
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 10
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- standard factor
- AF for remaining uncertainties:
- 1
- Justification:
- standard factor
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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