Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
871 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6
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:
208 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
24
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

In case of aerosol exposure, an acute inhalation DNEL, also used for long-term exposure to aerosol, was calculated at 4.4 mg/m3: Dose descriptor: LOAEC = 0.63 mg/m3. The LC50 1.73 g/m3 was found in an acute inhalation toxicity study using isohexadecane. The cause of the deaths was supposed to consist in local effects on surfactant, leading to collapsed lungs. As incomplete collapsed lungs were also observed at the lowest dose tested (0.63 g/m3), this dose level was chosen as a starting point for DNEL calculation. References: Duchosal, 1993. Assessment factors: Additional Modification factor: 4 (Uncertainty on the LOAEC (limited data, no histopathology)) and 3 (Assessment factor to reach a NOAEC); Interspecies factor: 3 (Toxic effects are local and of physical mechanism origin (no toxicokinetic differences implied)); Intraspecies factor: 2 (Worker Population for local effects); Duration factor: 2 (Haber’s law for time scaling, from 4 h to 8 h exposure = duration of a working day)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
185 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
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:
125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

In case of aerosol exposure, an acute inhalation DNEL, also used for long-term exposure to aerosol, was calculated at 3.5 mg/m3:

Dose descriptor: LOAEC = 0.63 mg/m3. The LC50 1.73 g/m3 was found in an acute inhalation toxicity study using isohexadecane. The cause of the deaths was supposed to consist in local effects on surfactant, leading to collapsed lungs. As incomplete collapsed lungs were also observed at the lowest dose tested (0.63 g/m3), this dose level was chosen as a starting point for DNEL calculation. References: Duchosal, 1993. Assessment factors: Additional Modification factor: 4 (Uncertainty on the LOAEC (limited data, no histopathology)) and 3 (Assessment factor to reach a NOAEC); Interspecies factor: 3 (Toxic effects are local and of physical mechanism origin (no toxicokinetic differences implied)); Intraspecies factor: 5 (ECETOC, 2003; General population).