Registration Dossier
Registration Dossier
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EC number: 238-729-3 | CAS number: 14689-29-3
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 152 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Systemic effects
- AF for dose response relationship:
- 1
- Justification:
- the NOAEL was at least 250 mg/kg bw
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic (2-year) study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- has already been done at the correction in sRV
- AF for other interspecies differences:
- 1
- Justification:
- hardly absorbed and not metabolized
- AF for intraspecies differences:
- 5
- Justification:
- standard assessment factor
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
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:
- 62 500 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):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 250 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
systemic effects
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is at least 250 mg/kg bw
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allomteric scaling
- AF for other interspecies differences:
- 1
- Justification:
- hardly absorbed and not metabolized
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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:
- 2.5 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 75 mg/m³
- Explanation for the modification of the dose descriptor starting point:
systemic effects
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is at least 250 mg/kg bw
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- has already been done at the correction in sRV
- AF for other interspecies differences:
- 1
- Justification:
- hardly absorbed and not metabolized
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 1
- Justification:
- no remaning uncertainties
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:
- 31 250 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 250 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
systemic effects
- AF for dose response relationship:
- 1
- Justification:
- NOAEL at least 250 mg/kg bw
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling
- AF for other interspecies differences:
- 1
- Justification:
- hardly absorbed and not metabolized
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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:
- 6.25 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
systemic effects
- AF for dose response relationship:
- 1
- Justification:
- NOAEL at least 250 mg/kg bw
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling
- AF for other interspecies differences:
- 1
- Justification:
- remaining differences in case of systemic effects
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 1
- Justification:
- no reamining uncertainties
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
See at justification and comments
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