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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 813-543-0 | CAS number: 73984-93-7
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:
- 2.93 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 220 ng/m³
- Explanation for the modification of the dose descriptor starting point:
250 mg/kg bw/day x (1/0.38) x (50% oral abs / 100% inhalation abs) x (6.7/10)
- AF for dose response relationship:
- 1
- Justification:
- No adverse effects observed in repeat dose, genotoxic or reproductive studies
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for subacute to chronic study extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already taken into account during the correction of starting dose
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for workers
- AF for intraspecies differences:
- 5
- Justification:
- Default factors for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for tonnage
- 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:
- 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:
- 0.83 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:
- 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default valie in ECHA guidance document
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value in ECHA guidance document
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat to human according to ECHA guidance document
- AF for other interspecies differences:
- 2.5
- Justification:
- Default, no substance and route specific information on toxicokinetic and toxicodynamics is available for animals and human
- AF for intraspecies differences:
- 5
- Justification:
- Default factors for workers as per ECHA guidance document
- AF for the quality of the whole database:
- 1
- Justification:
- Database is of high quality (GLP guideline study)
- 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:
- 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:
- 0.73 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 109 mg/m³
- Explanation for the modification of the dose descriptor starting point:
250*1/1.15*0.5 = 109 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Deafulat value according to ECHA guidance document
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value according to ECHA guidance document
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling should be applied in case of oral to inhalation exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA guidance document. No substance and route specific information on toxicokinetic and toxicodynamic is available for animals and human
- AF for intraspecies differences:
- 10
- Justification:
- Default value in ECHA guidance document for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Data base is of high quality (GLP guideline study)
- 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:
- 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:
- 0.42 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:
- 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default value according to ECHA guidance documnet
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value according to ECHA guidance document
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor according to ECHA guideance document for exprapolation from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor: No substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 10
- Justification:
- Default factor according to ECHA guidance document for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Database is of high quality (GLP guideline study)
- 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:
- 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:
- 0.42 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:
- 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default value according to ECHA guidance document
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value according to ECHA guidance document
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value according to ECHA guidance document for extrpolation from rats to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA guidance documents: No substance and route specific information on toxicokinetic and toxicodynamic is available
- AF for intraspecies differences:
- 10
- Justification:
- Default value according to ECHA guidance document for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Database is of high quality (GLP guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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.
