Registration Dossier
Registration Dossier
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EC number: 229-347-8 | CAS number: 6484-52-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 36 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):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 451 mg/m³
- Explanation for the modification of the dose descriptor starting point:
kinetics (metabolism, distribution and excretion) are considered to be similar for oral and inhalation intake in the absence of evidence of the opposite
- AF for dose response relationship:
- 1
- Justification:
- value is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- based on 1-y study (chronic exposure for workers)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no correction for caloric demand as it is inlcuded in the dose descriptor starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- difference in sensitivity among workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies
- AF for remaining uncertainties:
- 1
- Justification:
- not relevant
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.12 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):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 256 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
kinetics (metabolism, distribution and excretion) are considered to be similar for oral and dermal intake in the absence of evidence of the opposite
- AF for dose response relationship:
- 1
- Justification:
- value is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- based on a 1-y study (chronic exposure for worker)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- correction for caloric demand
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- difference is sensitivity among workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies
- AF for remaining uncertainties:
- 1
- Justification:
- not relevant
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:
- 8.9 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 223 mg/m³
- Explanation for the modification of the dose descriptor starting point:
kinetics (metabolism, distribution and excretion) are considered to be similar for oral and inhalation intake in the absence of evidence of the opposite
- AF for dose response relationship:
- 1
- Justification:
- value is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- based on a 1y study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no correction for caloric demand for inhalation as this is already included in the dose descriptor starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- differences in sensitivity among the general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies
- AF for remaining uncertainties:
- 1
- Justification:
- not relevant
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.56 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 256 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
kinetics (metabolism, distribution and excretion) are considered to be similar for oral and dermal intake in the absence of evidence of the opposite
- AF for dose response relationship:
- 1
- Justification:
- value is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- based on a 1y study (chronic exposure)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- alloometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- differences in sensitivity among the general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies
- AF for remaining uncertainties:
- 1
- Justification:
- not relevant
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:
- 2.56 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 256 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
not relevant
- AF for dose response relationship:
- 1
- Justification:
- value is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- based on a 1-y study (chronic exposure)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- difference in sensitivy among the general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies
- AF for remaining uncertainties:
- 1
- Justification:
- not relevant
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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