Registration Dossier
Registration Dossier
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EC number: 425-220-8 | CAS number: 5945-33-5
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
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.72 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF is not used for inhalation route
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- 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:
- 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
DN(M)EL-Worker
From the available studies, a NOAEL for sub-acute repeated dose toxicity study ( (Method B7 of directive 92/69/EEC) is used as the starting point for DNEL calculations.
Dermal DN(M)EL
Starting point: NOAEL 1000 mg/kg bw/day from sub-acute repeated dose toxicity study
Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1
Corrected NOAEL: 1000mg/kg bw/day
Interspecies differences: Allometric scaling: 4
Remaining interspecies differences: 2.5
Intraspecies differences: 5
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 300
=>Worker DNEL long-term for dermal route-systemic: 3.33mg/kg bw/day
Inhalation DN(M)EL
Starting point: NOAEL 1000 mg/kg bw/day from sub-acute repeated dose toxicity study
Respiratory volume rat (sRV) (worker (8 h): 1/0.38): 2.632
Differences in respiratory volume (default factor "light activity worker"): 0.67
Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
=>Corrected NOAEC: 881.72 mg/m3
Interspecies differences: Allometric scaling: 1
Remaining interspecies differences: 2.5
Intraspecies differences: 5
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 75
=>Worker DNEL long-term for inhalation route-systemic: 11.75 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.89 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.8 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF is not used for inhalation route
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- 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:
- no hazard identified
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:
- 1.66 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- 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:
- 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:
- 1.66 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- 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:
- no hazard identified
Additional information - General Population
DNEL General Population
From the available studies, a NOAEL for sub-acute repeated dose toxicity study (Method B7 of directive 92/69/EEC) is used as the starting point for DNEL calculations.
Oral DNEL
Starting point: NOAEL 1000mg/kg bw/day from sub-acute repeated dose toxicity study
Interspecies differences: Allometric scaling: 4
Remaining interspecies differences: 2.5
Intraspecies differences: 10
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 600
=>General population DNEL long-term for oral route-systemic: 1.66 mg/kg bw/day
Dermal DNEL
Starting point: NOAEL 1000 mg/kg bw/day from oral route
Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1
Corrected NOAEL: 1000 mg/kg bw/day
Interspecies differences: Allometric scaling: 4
Remaining interspecies differences: 2.5
Intraspecies differences: 10
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 600
=> General population DNEL long-term for dermal route-systemic: 1.66 mg/kg bw/day
Inhalation DN(M)EL
Starting point: NOAEL 1000mg/kg bw/day from oral route
Respiratory volume rat (sRV) (general population (24 h): 1/1.15): 0.8696
Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
=>Corrected NOAEC: 434.8 mg/m3
Interspecies differences: Allometric scaling: 1
Remaining interspecies differences: 2.5
Intraspecies differences: 10
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 150
=>General population DNEL long-term for inhalation route-systemic: 2.89 mg/m3
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