Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.75 mg/m³
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
100
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Value:
2.5
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
185 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Additional information - workers

The substance is a glassy solid handled as a hot liquid, in pastilles or in flakes. Thus there is no conventional particle size associated with the material. The principal health hazard arises from the transfer as a hot liquid - i.e. thermal injury. Although theoretically absorbable (slightly soluble in water and log Pow in an approriate range) the systemic toxicity following administration of the substance in food is low, possibly suggesting poor absorption, and does not lead to classification. Thus the critical effect is skin sensitisation.

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:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
185 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
100
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The key elements concerning human health are thermal injury due to hot liquid (workers) and skin sensitisation (workers and consumers). The substance is otherwise essentially non-toxic - whether the limited effects seen in the repeated dose study were due to toxicity or unpalatability is a judgement. For the purposes of this report the effects seen at the highest dose were treated as toxic effects.