Registration Dossier
Registration Dossier
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EC number: 824-458-3 | CAS number: 1263679-68-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 357.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 8 927.75 mg/m³
- Explanation for the modification of the dose descriptor starting point:
6.7/10 m3was considered appropriate to address the different respiratory volumes between individuals at rest and workers under light work activity.
- AF for dose response relationship:
- 1
- Justification:
- This is the default value.
- AF for differences in duration of exposure:
- 2
- Justification:
- A scaling factor for using a subchronic study for a chronic endpoint was used.
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Data produced for rats is used to derive a human DNEL.
- AF for intraspecies differences:
- 5
- Justification:
- A factor of 5 is selected for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The data is of good quality (from guideline studies).
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 856.88 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 35 711 mg/m³
- Explanation for the modification of the dose descriptor starting point:
6.7/10 m3was considered appropriate to address the different respiratory volumes between individuals at rest and workers under light work activity.
- AF for dose response relationship:
- 1
- Justification:
- This is the default value.
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Data produced for rats is used to derive a human DNEL.
- AF for intraspecies differences:
- 5
- Justification:
- A factor of 5 is selected for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The data is of good quality (from guideline studies).
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:
- no hazard identified
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:
- 266.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 13 325 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- A scaling factor for using a subchronic study for a chronic endpoint was used.
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Data produced for rats is used to derive a human DNEL.
- AF for intraspecies differences:
- 10
- Justification:
- A factor of 10 is selected for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The data is of good quality (from guideline studies).
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 132 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 53 300 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default value.
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Data produced for rats is used to derive a human DNEL.
- AF for intraspecies differences:
- 10
- Justification:
- A factor of 10 is selected for the general population.
- AF for the quality of the whole database:
- 1
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:
- no hazard identified
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:
- no hazard identified
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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