Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
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:
10.35 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Acute DNELs

As the substance is not considered to be toxic or harmful after oral and dermal exposure, acute (systemic) DNELs do not need to be derived.

As the substance is not considered to be irritating to skin and eyes, acute (local) DNELs do not need to be derived.

Long-term DNELs

The NOAELs of the 90-day sub-chronic oral toxicity study in rats and of the reproduction/developmental toxicity screening study in the rats are 207 and 1000 mg/kg bw/day, respectively. As the NOAEL of the 90-day sub-chronic study appears to be the critical NOAEL, this value is used for the DNEL determination.

To arrive at a long-term value for the dermal route for workers, route to route extrapolation will be applied starting with the NOAEL of the sub-chronic study. Given the molecular weight and the octanol/water partition coefficient, it is expected that dermal absorption will be low (10%). Oral absorption is assumed to be 50%. The assessment factor is 100 (10 for interspecies differences (4 for allometric scaling, 2.5 for remaining differences), 5 for intraspecies differences, and an additional factor of 2 (to take account of the lower sensitivity of the sub-chronic study)). As a result, the dermal DNEL is:

207 mg/kg bw/day x (50%/10%) / 100 = 10.35 mg/kg bw/day

To arrive at a long-term value for the inhalation route for workers, route to route extrapolation will be applied starting with the NOAEL of the oral screening study. As worst case approach, 50% oral and 100% inhalation absorption is assumed. The assessment factor is 25 (2.5 for interspecies differences (no value for allometric scaling, 2.5 for remaining differences), 5 for intraspecies differences, and an additional factor of 2 (to take account of the lower sensitivity of the sub-chronic study)). Also considering the respiration volume of rat and human (specifically the worker), the inhalation DNEL is:

(207 mg/kg bw/day * 1 / 0.38 m3/kg bw * 50% / 100% * 6.7m3/person / 10m3/person) / 25 = 7.30 mg/m3

As local effects were not observed in the repeated dose toxicity study, long term (local) DNELs do not need to be derived.

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

The substance is not readily available to consumers, as there is very little potential for the substance to be released from the polymers once it has been consumed in the polymer manufacturing process. Therefore, DNELs for the general population do not need to be derived.