Registration Dossier
Registration Dossier
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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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