Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.3 mg/m³
DNEL related information
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.3 mg/m³
DNEL related information
Modified dose descriptor starting point:
NOAEC

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:
20 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL

Workers - Hazard for the eyes

Additional information - workers

From the data presented in Sections 7.3 to 7.8, it can be concluded that the substance is not an irritant or sensitiser, and that there is no evidence of CMR effects, therefore hazard may be estimated from threshold concentrations (DNELs), since DMELs are not relevant to threshold substances.

From the physical-chemical properties provided in Section 4 and from the exposure pattern of operators in the workplace, the potential for exposure is via dermal and inhalation routes.

In conclusion, the substance may be considered a threshold substance, and it is appropriate to derive DNELs for relevant routes of exposure (dermal, inhalation) for operators in the workplace.

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

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL

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

From the data presented in Sections 7.3 to 7.8, it can be concluded that the substance is not an irritant or sensitiser, and that there is no evidence of CMR effects, therefore hazard may be estimated from threshold concentrations (DNELs), since DMELs are not relevant to threshold substances.

From the physical-chemical properties provided in Section 4 and from the exposure pattern of the general population to the formulated product, the potential for exposure is via the dermal route.

In conclusion, the substance may be considered a threshold substance, and it is appropriate to derive DNELs for the relevant route of systemic exposure (dermal) for the general population.