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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 250-528-2 | CAS number: 31242-17-8
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:
- 7.05 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:
- 528 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- default (three doses were tested, using a spacing range of 2-4 fold)
- AF for differences in duration of exposure:
- 6
- Justification:
- since it is a sub-acute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scalling should be applied in case of oral-to-inhalation extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 5
- Justification:
- default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- default
- 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:
- 1 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:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A NOAEL of 300 mg/kg bw /day from an oral 28 day repeated dose toxicity study. As a conservative approach, 100% absorption is assumed by both routes.
- AF for dose response relationship:
- 1
- Justification:
- default (three doses were tested, using a spacing range of 2-4 fold)
- AF for differences in duration of exposure:
- 6
- Justification:
- since it is a sub-acute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 5
- Justification:
- default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties are 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:
- 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:
- 1.738 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:
- 260.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Oral NOAEL of 300 mg/kg bw /day, corrected for inhalation 300 x (1/1.15) x (100/100) = 260.7 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- default (three doses were tested, using a spacing range of 2-4 fold)
- AF for differences in duration of exposure:
- 6
- Justification:
- since it is a subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scalling should be applied in case of dermal-to-inhalation extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 10
- Justification:
- default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties are 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:
- 0.5 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:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A NOAEL of 300 mg/kg bw /day from an oral 28 day repeated dose toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- default (three doses were tested, using a spacing range of 2-4 fold)
- AF for differences in duration of exposure:
- 6
- Justification:
- since it is a subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 10
- Justification:
- default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties are 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:
- 0.5 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:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default (three doses were tested, using a spacing range of 2-5 fold)
- AF for differences in duration of exposure:
- 6
- Justification:
- since it is a subacute
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
- AF for intraspecies differences:
- 10
- Justification:
- default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties are 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:
- 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.
