Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.