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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-819-8 | 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:
- 29.5 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 750 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Procedure following ECHA's guideline R.8, Example R.8-2:
The allometric scaling factor of 4 is already included into the NOAEC.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- none known
- AF for intraspecies differences:
- 5
- Justification:
- human to worker
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 2
- Justification:
- route of exposure (oral -> inhalative)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 350 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 500 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point is the LD50(oral) of >2.000 mg/kg bw
Procedure following ECHA's guideline R.8, Example R.8-2 for deriving the modified starting point.
The allometric scaling factor of 4 is already included into the NOAEC.
- AF for dose response relationship:
- 1
- Justification:
- LD50 can be considered as NOAEL in this case
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- none known
- AF for intraspecies differences:
- 5
- Justification:
- human to worker
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 2
- Justification:
- route of exposure (oral -> inhalative)
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:
- 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):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification required.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- none known
- AF for intraspecies differences:
- 5
- Justification:
- human to worker
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 1
- Justification:
- none known
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 100 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- other: LD50
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification required.
- AF for dose response relationship:
- 1
- Justification:
- LD50 can be considered as a NOAEL in this case
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- none known
- AF for intraspecies differences:
- 5
- Justification:
- human to worker
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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:
- 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:
- 15 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):
- 480
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 750 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Procedure following ECHA's guideline R.8, Example R.8-2:
The allometric scaling factor of 4 is already included into the NOAEC.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- none known
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 2
- Justification:
- route of exposure (oral -> inhalative)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 175 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 500 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point is the LD50(oral) of >2.000 mg/kg bw
Procedure following ECHA's guideline R.8, Example R.8-2 for deriving the modified starting point.
The allometric scaling factor of 4 is already included into the NOAEC.
- AF for dose response relationship:
- 1
- Justification:
- LD50 can be considered as NOAEL in this case
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 10
- Justification:
- human to general population
- AF for intraspecies differences:
- 1
- Justification:
- none known
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 2
- Justification:
- route of exposure (oral -> inahalative)
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:
- 4 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification required.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- none known
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 1
- Justification:
- none known
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- other: LD50
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification required.
- AF for dose response relationship:
- 1
- Justification:
- LD50 can be considered as a NOAEL in this case
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- none known
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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:
- 4 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- none known
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 1
- Justification:
- none known
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- other: LD50
- Value:
- 2 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- LD50 can be considered as a NOAEL in this case
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- none known
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
- AF for the quality of the whole database:
- 1
- Justification:
- good/standard quality of the database with respect to completeness, consistency and the standard information requirements
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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.
