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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 211-470-3 | CAS number: 646-24-2
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:
- 0.35 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:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 53 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Corrosivity and follow up effects were the main symptoms in the oral study. These are also anticipated to guide the inhalation exposure. As point of departure for the assessment a corrected inhalative systemic NOAEC was calculated from the oral NOAEL following route-to route-extrapolation for workers with AF of (6.7/10/0.38) kg bw /m³/d as in guidance R.8.
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default
- AF for differences in duration of exposure:
- 6
- Justification:
- guidance R.8 default (subacute - chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- guidance R.8 default
- AF for other interspecies differences:
- 1
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 5
- Justification:
- guidance R.8 default for workers
- AF for the quality of the whole database:
- 2
- Justification:
- Read across from MODA oral subacute endpoint with safety factor of 2 (quality of data set)
- AF for remaining uncertainties:
- 2.5
- Justification:
- guidance R.8 default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A worst case assumption of 100% dermal absorption is used. Corrosivity and follow up effects were the main symptoms in the oral study.
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default
- AF for differences in duration of exposure:
- 6
- Justification:
- guidance R.8 default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- guidance R.8 default
- AF for other interspecies differences:
- 1
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 5
- Justification:
- guidance R.8 default
- AF for the quality of the whole database:
- 2
- Justification:
- Read across from MODA oral subacute endpoint with safety factor of 2 (quality of data set)
- AF for remaining uncertainties:
- 2.5
- Justification:
- guidance R.8 default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high 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:
- 0.09 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:
- 26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The oral 28 day study of MODA is the longest test giving the most reliable results. Route to route extrapolation following ECHA guidance example R.8-1 for general population was adopted with AF = 0.87 m³* d/kg bw.
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default
- AF for differences in duration of exposure:
- 6
- Justification:
- guidance R.8 default
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- guidance R.8 default
- AF for other interspecies differences:
- 1
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 10
- Justification:
- guidance R.8 default
- AF for the quality of the whole database:
- 2
- Justification:
- Read across from MODA oral subacute endpoint with safety factor of 2 (quality of data set)
- AF for remaining uncertainties:
- 2.5
- Justification:
- guidance R.8 default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 µg/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):
- 1 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A worst case assumption of 100% dermal absorption is used. Corrosivity and follow up effects were the main symptoms in the oral study.
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default
- AF for differences in duration of exposure:
- 6
- Justification:
- guidance R.8 default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- guidance R.8 default
- AF for other interspecies differences:
- 1
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 10
- Justification:
- guidance R.8 default
- AF for the quality of the whole database:
- 2
- Justification:
- Read across from MODA oral subacute endpoint with safety factor of 2 (quality of data set)
- AF for remaining uncertainties:
- 2.5
- Justification:
- guidance R.8 default
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 µg/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):
- 1 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default
- AF for differences in duration of exposure:
- 6
- Justification:
- guidance R.8 default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- guidance R.8 default
- AF for other interspecies differences:
- 1
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 10
- Justification:
- guidance R.8 default
- AF for the quality of the whole database:
- 2
- Justification:
- Read across from MODA oral subacute endpoint with safety factor of 2 (quality of data set)
- AF for remaining uncertainties:
- 2.5
- Justification:
- guidance R.8 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:
- high 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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