Registration Dossier
Registration Dossier
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EC number: 225-218-5 | CAS number: 4724-48-5
Toxicological information
Toxicological Summary
Currently viewing:
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 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:
- 12 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Corrected NOAEC = Oral NOAEL * (1/sRV rat 8h) * (ABS oral-rat / ABS inh-human) * (sRV human 8h / wRV 8h) with sRV rat 8h = 0.38 m3/kg bw; ABS oral rat = 50%; ABS inh-human=100% ; sRV human 8h = 6.7 m3/person; wRV 8h = 10 m3/person
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor used for interspecies remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal NOAEL = oral NOAEL * (ABS oral / ABS dermal) with ABS oral = ABS dermal as no specific data on dermal absorption
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor for interspecies differences Rat vs Human
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor used for interspecies remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.071 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Corrected NOAEC = Oral NOAEL * (1/sRV rat 8h) * (ABS oral-rat / ABS inh-human) * (sRV human 8h / wRV 8h) with sRV rat 8h = 0.38 m3/kg bw; ABS oral rat = 50%; ABS inh-human=100% ; sRV human 8h = 6.7 m3/person; wRV 8h = 10 m3/person
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor used for interspecies remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor for the General population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 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
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.02 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 12 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor for interspecies differences Rat vs Human
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor used for interspecies remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor for the General population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
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 for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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