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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 248-698-8 | CAS number: 27859-58-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
100 x 1/0.38 x 6.7/10 x 0.5 [50% oral absorption rat / 100% inhalation absorption human]
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was derived
- AF for differences in duration of exposure:
- 6
- Justification:
- default - subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- differences between rats and humans already taken into account when modifying the starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- default - any remaining difference
- AF for intraspecies differences:
- 5
- Justification:
- default - workers
- AF for the quality of the whole database:
- 1
- Justification:
- database complete for the tonnage band
- AF for remaining uncertainties:
- 1
- Justification:
- DNEL based on experimental data on the substance. 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:
- 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:
- 0.7 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
100 x 2 [oral absorption rat 50%/dermal absorption human 25%]
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was derived
- AF for differences in duration of exposure:
- 6
- Justification:
- default - subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default - any remaining difference
- AF for intraspecies differences:
- 5
- Justification:
- default - workers
- AF for the quality of the whole database:
- 1
- Justification:
- database complete for the tonnage band
- AF for remaining uncertainties:
- 1
- Justification:
- DNEL based on experimental data on the substance. There were no remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
The registered substance was not acutely toxic via the oral route of exposure, was demonstrated to to be non-genotoxic in a battery of genotoxicity studies appropriate to the tonnage, not developmentally toxic or toxic for reproduction in a reproductive screening study, and to possess a NOAEL of 100 mg/kg bw/day in a 28 day repeat dose toxicity study. This was the most critical NOAEL for deriving the risk assessment.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
100 x 1/1.15 x 0.5 [oral abosrption rat 50%/inhalation absorption human 100%]
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was derived
- AF for differences in duration of exposure:
- 6
- Justification:
- default - subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- differences between rats and humans already taken into account for modifying the starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- default - any remaining difference
- AF for intraspecies differences:
- 10
- Justification:
- default - general population
- AF for the quality of the whole database:
- 1
- Justification:
- database complete for the ton bandage
- AF for remaining uncertainties:
- 1
- Justification:
- DNEL based on experimental data on the substance
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
100 x 2 [oral absorption rat 50%/dermal absorption human 25%]
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was derived
- AF for differences in duration of exposure:
- 6
- Justification:
- default - subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- any remaining difference
- AF for intraspecies differences:
- 10
- Justification:
- default - general population
- AF for the quality of the whole database:
- 1
- Justification:
- database complete for the ton bandage
- AF for remaining uncertainties:
- 1
- Justification:
- DNEL based on experimental data on the substance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.2 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
oral absorption in rats = oral absorption in humans
- AF for dose response relationship:
- 1
- Justification:
- Aclear NOAEL was derived
- AF for differences in duration of exposure:
- 6
- Justification:
- default - subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- any remaining difference
- AF for intraspecies differences:
- 10
- Justification:
- default - general population
- AF for the quality of the whole database:
- 1
- Justification:
- database complete for the ton bandage
- AF for remaining uncertainties:
- 1
- Justification:
- DNEL based on experimental data for the substance.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
The registered substance was not acutely toxic via the oral route of exposure, was demonstrated to to be non-genotoxic in a battery of genotoxicity studies appropriate to the tonnage, not developmentally toxic or toxic for reproduction in a reproductive screening study, and to possess a NOAEL of 100 mg/kg bw/day in a 28 day repeat dose toxicity study. This was the most critical NOAEL for deriving the risk assessment.
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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