Registration Dossier
Registration Dossier
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EC number: 234-845-3 | CAS number: 12036-32-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.9 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Oral absorption estimated to be 1%, inhalation absorption estimated to be 2%.
Oral NOAELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (1% /2%) = 1000 × 2.63 × 0.67 × 0.5
Inhalation NOAEChuman= 881.1 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL has been defined
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NA 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:
- 2
- Justification:
- Read across data used
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value - no other diffferences identified
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:
- 1.7 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral NOAELrat× (1% /1%) = 1000 × 1
Dermal NOAELhuman= 1000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL defined
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for 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:
- 2
- Justification:
- Read across data used
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value no other uncertanties identified
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
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Oral NOAELrat× (1/1.15 m3/kg bw) × (1% /2%) = 1000 × 0.87 × 0.5
Inhalation NOAEChuman= 435 mg/m3- AF for dose response relationship:
- 1
- Justification:
- NOAEL Defined
- AF for differences in duration of exposure:
- 6
- Justification:
- default for subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NA for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- addressed by modification of starting dose
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population
- AF for the quality of the whole database:
- 2
- Justification:
- Read across data used
- AF for remaining uncertainties:
- 2.5
- Justification:
- default valuem, no other uncertainties identified
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:
- 0.8 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):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral NOAELrat× (1% /1%) = 1000 × 1
Dermal NOAELhuman= 1000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL identified
- AF for differences in duration of exposure:
- 6
- Justification:
- default value for Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value for rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population
- AF for the quality of the whole database:
- 2
- Justification:
- Read across data used
- AF for remaining uncertainties:
- 2.5
- Justification:
- default value used, no other uncertainties identified
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.8 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):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral NOAELrat= Oral NOAELhuman= 1000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL defined
- AF for differences in duration of exposure:
- 6
- Justification:
- default for subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting dose
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population
- AF for the quality of the whole database:
- 2
- Justification:
- read across data used
- AF for remaining uncertainties:
- 2.5
- Justification:
- default value no other uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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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