Registration Dossier
Registration Dossier
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EC number: 235-979-5 | CAS number: 13078-36-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.88 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:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 66 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A corrected inhalation NOAEC was calculated on the basis of the oral NOAEL in rat (75 mg/kg bw/day) by using default respiratory volumes from the rat to the daily duration of humans.
Correction respiratory value rat (8 hours) 1/0.38 m3/kg/day
Correction respiratory volume worker 6.7/10 m3
Correction oral to inhalation 1/2
The corrected NOAEL for respiratory systemic effects 75 (1/0.38) (6.7/10)(1/2) = 66 mg/m3
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- 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:
- 1.25 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):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose decrptor starting point of 75 mg/kg/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 2
- Justification:
- The adverse effects of the substance are related to the withdrawal of essential metal ions, a mode of action which would be largely independent of species. A value of 2 is therefore used to cover any remaining interspecies differences.
- AF for other interspecies differences:
- 1
- 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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.22 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:
- NOAEC
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 33 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A corrected inhalation NOAEC was calculated on the basis of the oral NOAEL in rat (75 mg/kg bw/day) by using default respiratory volumes from the rat to the daily duration of humans.
Correction respiratory value rat to human 1/1.15 m3/kg/day
Correction oral to inhalation 1/2
The corrected NOAEL for respiratory systemic effecets 75 (1/1.15) (1/2) = 33 mg/m3
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- 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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.625 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):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor starting point of 75 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 2
- Justification:
- The adverse effects of the substance are related to the withdrawal of essential metal ions, a mode of action which would be largely independent of species. A value of 2 is therefore used to cover any remaining interspecies differences.
- AF for other interspecies differences:
- 1
- 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:
- 0.625 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):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor starting point of 75 mg/kg/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 2
- Justification:
- The adverse effects of the substance are related to the withdrawal of essential metal ions, a mode of action which would be largely independent of species. A value of 2 is therefore used to cover any remaining interspecies differences.
- AF for other interspecies differences:
- 1
- 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
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