Registration Dossier
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EC number: 931-210-9 | CAS number: 1266534-73-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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:
- 25 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
Dermal:
No repeated dose toxicity data after dermal administration of Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony are available. Therefore, data from the structural analogue substance Zeolite, cuboidal, crystalline, synthetic, non-fibrous (EC No. 930-915-9) (Bartnik 1976, RL2) serves as data source for the derivation of a dermal long-term, systemic DNEL. An oral NOAEL of 250 mg/kg bw/d for male rats was identified in this study.
The available dose descriptor (NOAEL oral route, systemic effect) is 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 NOAEL (in mg/kg bw/d) into a dermal NAEL (in mg/kg bw/d), the differences in absorption between routes as well as interspecies differences in dermal absorption have to be accounted for.
Based on the assumption that, in general, dermal absorption will be much lower than oral absorption, a conservative factor of 10% absorption is assumed when performing oral to dermal extrapolation (factor 10). Furthermore the same bioavailability for experimental animals (rats) and humans is assumed (i.e. factor 1). These assumptions result in the following NAEL for the dermal exposure route:
NAEL dermal (corr) = NOAEL oral x 10 x 1 = 250 mg/kg bw/d x 10 x 1 = 2500 mg/kg bw/d
The following assessment factors were applied: Allometric scaling: 2.5; Interspecies 4; Intraspecies: 5; Duration of exposue 2; Quality of database: 1
AF = 2.5 x 4 x 5 x 2 = 100
DNEL long term systemic dermal = NAEL dermal / AF = 2500 mg/kg bw/d / 100 = 25 mg/kg bw/d
Inhalation:
Preliminary investigations aiming at creating a sufficiently respirable test atmosphere of Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony demonstrated that the test material is not capable of forming respirable dust (Weniger, 2010, RL1). The dust generated in the various preliminary experiments contained a respirable fraction (1-4 µm) of only about 1% and therefore has an inherently low exposure potential to the alveolar region of the lung.
As the exposure of Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony at the workplace is neither regulated on the EU level nor in any of the member states, DNELs for the exposure at the workplace are based on generic dust limits. The generic dust limits for inorganic dust is defined 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/m3 for inhalable and 3 mg/m3 for respirable dust.
As the existence of respirable particles can be excluded for Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony, the generic dust limit for the inhalable fraction of inorganic dust (i.e. 10 mg/m3) is used as inhalation DNEL for long-term systemic and long term local effects. 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
Based on the identified uses, the general population is not exposed to Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony. Thus, no DNELs were derived for the general population.
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