Registration Dossier
Registration Dossier
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EC number: 214-604-9 | CAS number: 1163-19-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
Workers - Hazard for the eyes
Additional information - workers
The worker inhalation DNEL long-term exposure, systemic effects, was calculated to be 6 mg/m3. This is consistent with the acceptable workplace exposure limit of 5 mg/M3 established by the American Council of Governmental Hygenists.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 70 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
General Population - Hazard for the eyes
Additional information - General Population
The general public inhalation DNEL long-term systemic exposure was calculated to be 70 mg/m3, while the oral DNEL for long-term systemic exposure was calculated to be 20 mg/kg bw/d. These DNELs compare favorably to the U.S. ATSDR intermediate-duration reference dose for the general population of 10 mg/kg bw/d, the U.S. National Research Council's lifetime oral RfD of 4 mg/kg/d, and the oral RfD of 4 mg/kg/d developed by Hardy et al. (2009) using bench mark dose modeling. While the U.S. Intgrated Risk Information System (IRIS) published an RfD of 0.007 mg/kg/d in 2008, this RfD was improperly based on Viberg et al. (2003), which is not reliable and disregarded in this assessment. To investigate the effects reported by Viberg et al. after a single dose of 20 mg/kg, a robust, guideline- and GLP-compliant developmental neurotoxicity study was performed, which demonstrated a NOAEL of 1000 mg/kg bw/day.
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