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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 457-320-2 | CAS number: -
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:
- 3.52 mg/m³
- Most sensitive endpoint:
- neurotoxicity
- 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:
- 264.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As per ECHA guidance R8, NOAEL / 0.38 * (6.7/10) * 0.5 [50% oral absorption rat / 100% inhalation absorption human].
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Starting point already adjusted
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for systemic
- AF for intraspecies differences:
- 5
- Justification:
- Default for worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 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:
- 2.23 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 670 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Sub-acute dermal study available so no modification of dose descriptor needed
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for systemic
- AF for intraspecies differences:
- 5
- Justification:
- Default for worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.075 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- modified NOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No AF applied as mechanism of irritation is considered the same between animals and humans
- AF for other interspecies differences:
- 1
- Justification:
- No AF applied as mechanism of irritation is considered the same between animals and humans
- AF for intraspecies differences:
- 5
- Justification:
- Default: workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 1.76 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:
- 264.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As per ECHA guidance R8, NOAEL / 0.38 * (6.7/10) * 0.5 [50% oral absorption rat / 100% inhalation absorption human].
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already modified dose descriptor for inhalation exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- Default - systemic
- AF for intraspecies differences:
- 10
- Justification:
- Default - general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 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:
- 1.12 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 670 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default - systemic
- AF for intraspecies differences:
- 10
- Justification:
- Default - general population
- AF for the quality of the whole database:
- 11
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.038 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No AF applied as mechanism of irritation is considered the same between animals and humans
- AF for other interspecies differences:
- 1
- Justification:
- No AF applied as mechanism of irritation is considered the same between animals and humans
- AF for intraspecies differences:
- 10
- Justification:
- Default: general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- neurotoxicity
- 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:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Default - sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default - systemic
- AF for intraspecies differences:
- 10
- Justification:
- Default - general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
