Registration Dossier
Registration Dossier
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EC number: 476-880-9 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.53 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.45 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalatory NOAEC=oral NOAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh)
Assuming absorption oral/absorption inhalatory= 0.5.
- AF for dose response relationship:
- 1
- Justification:
- Starting point = NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- AF for remaining uncertainties:
- 2
- Justification:
- Read-across
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:
- 0.15 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL=oral (NOAEL*(ABS oral/ABS dermal)
ABS oral/ABS dermal = 1
- AF for dose response relationship:
- 1
- Justification:
- Starting point = NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- Workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- AF for remaining uncertainties:
- 2
- Justification:
- Read-across
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:
- 0.13 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13.04 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation NOAEC=oral NOAEL*(1/1.15 m3/kg/d)*(ABS oral/ABS inh)
ABS oral/ABS inh = 0,5
- AF for dose response relationship:
- 1
- Justification:
- Starting point = NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- AF for remaining uncertainties:
- 2
- Justification:
- Read-across.
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL oral (NOAEL*(ABS oral/ABS dermal)
ABS oral/ABS dermal = 1
- AF for dose response relationship:
- 1
- Justification:
- Starting point = NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 10
- Justification:
- General population.
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- AF for remaining uncertainties:
- 2
- Justification:
- Read-across.
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:
- 0.08 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point = NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 10
- Justification:
- General population.
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- AF for remaining uncertainties:
- 2
- Justification:
- Read-across.
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
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