Registration Dossier
Registration Dossier
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EC number: 204-623-0 | CAS number: 123-38-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.1 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):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 181.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- not required
- AF for dose response relationship:
- 1
- Justification:
- NOAEC used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- standard factor for subacute to chronic, conservative considering exposure for 52 days.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required
- AF for other interspecies differences:
- 1
- Justification:
- Leading effect is local irritation, for which no further difference in addition to those based on respiration volume and exposure time are expected. Rather, irritation is expected to be worse in rats as obligate nasal breathers. Additionally, a conservative approach was already chosen for time extrapolation.
- AF for intraspecies differences:
- 5
- Justification:
- default value
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- LOAEC
- AF for dose response relationship:
- 3
- Justification:
- LOAEC used as starting point
- AF for differences in duration of exposure:
- 1
- Justification:
- effects observed after 52 days were minimal even at the mid dose
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required
- AF for other interspecies differences:
- 1
- Justification:
- Irritation is expected to be worse in rats as obligate nasal breathers.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
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