Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.52 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.52 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.52 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
50
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.52 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Tumors were observed in both oral and inhalation carcinogenicity studies, but were route-specific: the oral route produced forestomach tumors, while the inhalation route produced respiratory tract tumors. Since the substance is irritating, these route-specific effects could have been mediated via repeated injury to portal-of-entry organs. No other systemic effects were observed. Thus, even though the substance is a genetic toxicant, the tumors observed in the carcinogenicity studies could be considered associated with repeated injury scenarios, or a threshold effect.

In subchronic toxicity studies, slight histologic and weight effects were noted on the kidneys and liver. The lowest NOAEL for these studies was used to calculate a systemic DNEL.

The calculated DNEL is consistent with many international Occupational Exposure Limits, including the US ACGIH TWA value of 1.9 mg/m3, the Austrian TRK of 12 mg/m3, the Belgian TWA of 2 mg/m3, etc.

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

Because of the effects noted with this substance, including severe irritancy and genetic toxicity, and because of the reactivity of the substance, it is handled a manner that precludes exposure to the general population, even in residual amounts. Therefore, no DNELs have been calculated for the general population.