Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
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:
2.5 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

Long term exposure - systemic effects: Dermal DNEL in mg/kg bw/day: 2.5 -3.0

In principle, if there is no dose descriptor for the dermal exposure route available, the available dose descriptor (oral route, systemic effect) can be converted into a correct starting point by route-to route extrapolation according to the ECHA guidance document "Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health", May 2008.

To convert an oral N(L)OAEL (in mg/kg bw/d) into a dermal N(L)OAEL, the differences in absorption between routes as well as differences in dermal absorption between rats and humans have to be accounted for. Since the oral bioavailablility of zeolites in beagle dogs is less than 3.5 % (Cefali et al. 1996, see chapter 7.1), the bioavailability can be neglected. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral to dermal extrapolation. Furthermore the same bioavailability for experimental animals and humans is assumed (no default factor, i.e.factor 1). This assumptions results in the identical N(L)OAEL for the oral and dermal exposure route.

As the synthetic zeolites exposure at the workplace is neither regulated on the EU level nor in any of the member states, the limits for the exposure at the workplace are derived from the generic dust limits. The generic dust limits for inorganic dust is defined in Germany in TRGS 900 chapter 2.6, taking into account particle size, solubility and density of the substance. The AGW (workplace exposure limits) are defined as 10 mg/m3for inhalable and 3 mg/m3for respirable dust. It is proposed to adopt the more critical value of 3 mg/m3 as DNEL. This approach is in compliance with the ECHA "Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health", May 2008.

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

Discussion

Oral, Dermal and Inhalation exposure is not a relevant toxicological issue for general population, based on substance properties, identified uses and experimental evidence. Therefore, a DNEL for Oral, Dermal and Inhalation is not derived for the general population.