Registration Dossier
Registration Dossier
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EC number: 926-000-9 | CAS number: 1180524-77-9
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:
- 7.05 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 528.95 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- according to the ECHA Guidance, Chapter R.8: Characterisation of dose-response for human health (November 2012). An allometric scaling factor from oral route (mg/kg bw/day) to the inhalation route of human exposure (mg/m³) is not required.
- AF for other interspecies differences:
- 2.5
- Justification:
- according to the ECHA Guidance, Chapter R.8: Characterisation of dose-response for human health (November 2012). Extrapolation considers a default factor of 2.5 for other remaining uncertainties.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- key study available
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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:
- 1.67 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):
- 180
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- ECHA default (rabbit)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default (remaining uncertainties)
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- key study available
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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)
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:
- 1.74 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 260.87 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- according to the ECHA Guidance, Chapter R.8: Characterisation of dose-response for human health (November 2012). An allometric scaling factor from oral route (mg/kg bw/day) to the inhalation route of human exposure (mg/m³) is not required.
- AF for other interspecies differences:
- 2.5
- Justification:
- according to the ECHA Guidance, Chapter R.8: Characterisation of dose-response for human health (November 2012). Extrapolation considers a default factor of 2.5 for other remaining uncertainties.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- key study availble
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 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):
- 360
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- ECHA default (rabbit)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default (remaining uncertainties)
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- key study availble
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 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):
- 360
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL availble
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- ECHA default (rabbit)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default (remaining differences)
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- key study available
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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