Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The substance is of low acute toxicity following oral and dermal exposure. The substance is not irritating either to the skin or to the eyes, and does not possess any skin sensitisation potential. On these bases no acute DNELs are required.

Data evaluating the genotoxic potential of the substance allow the conclusion that the substance is not genotoxic. A fully compliant OECD 422 study, under the worst condition of oral gavage, set the parental systemic as well as the reproductive and developmental toxicity NOEL at 1000 mg/kg bw/day, the limit dose, because treatment did not affect any of the parameters, including FOBs and motor activity assessments, as well as reproductive performence and development of offspring up to day 4 of lactation. This endpoint is considered appropriate to calculate long-term DNELs for workers exposure. An additional assessment factor of 2 was applied because data on reproductive and developmental toxicity are limited to the above-mentioned OECD 422 study and no data on chronic toxicity are available.

Taken together all the available toxicological information suggests that the substance should be at most minimally absorbed.

General Population - Hazard via inhalation 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
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:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The general population is not expected to be exposed to the substance.