Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
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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