Registration Dossier
Registration Dossier
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EC number: 293-214-0 | CAS number: 91052-53-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.75 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:
- 11.75 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Workers-Oral to inhalation: Inhalatory NOAEC= oral NOAEL*(1/0.38m3/kg/d)*0.67*(ABSoral/ABSinh.)=1000mg/kg/d*(1/0.38m3/ kg/d)*0.67*(0.5/1)=881.58mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.33 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:
- 3.33 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Differences in metabolic rate/body weight
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 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:
- 2.9 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:
- 2.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
General population-oral to inhalation: Inhalation NOAEC=oral NOAEL*(1/1.15m3/kg/d)*(ABSoral/ABSinh.)=1000mg/kg/d*(1/1.15m3/kg/ d)*(0.5/1)=434.78mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 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:
- 1.667 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:
- 1.667 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
General population- oral to dermal: Dermal NOAEC=oral NOAEL*(ABSoral/ABSdermal)=1000*(0.5/0.5)=1000mg/kg bw/day DNEL=dermal NOAEC/AF=1000mg/kg bw/day/(1*6*4*2.5*10*1*1)=1.667mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Differences in metabolic rate/body weight
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.667 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:
- 1.667 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Differences in metabolic rate/body weight
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
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