Aluminum antimony nickel silicon titanium vanadium oxide

Endpoint summary

Description of key information

oral: LD50 (rat) > 2000 mg/kg bw 
dermal: LD50 (rat) > 2000 mg/kg bw 
inhalation: LC50 not determined, as study technically not feasible

Additional information

In an acute oral toxicity study which was conducted according to OECD guideline 423, Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony was administered to a group of six female Sprague Dawley rats at the limit dose of 2000 mg/kg bw (Richeux 2010, RL1). No mortality occured during the study. No clinical signs related to the administration of the test material were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopic examinations of the animals at the end of the study did not reveal any treatment-related changes. In conclusion, the LD 50 was > 2000 mg/kg bw by oral route in the rat.

 

In an acute dermal toxicity study which was conducted according to OECD guideline 402, Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony was applied onto the intact skin of 5 male and 5 female Sprague Dawley rats at the limit dose of 2000 mg/kg bw (Richeux 2010, RLl). No mortality occured during the study. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test material were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal any treatment-related changes. In conclusion, the LD 50 was > 2000 mg/kg bw by dermal route in the rat.

 

Preliminary investigations aiming at creating a sufficiently respirable test atmosphere of Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony (Weniger, 2010, RL1) demonstrated that the test material cannot be dispersed into a test atmosphere that fulfils the requirements of OECD 403 and its related guidelines. Since state-of-the-art dust generation techniques were employed to no avail, it is concluded that Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony is not capable of forming respirable dust. The dust generated in the various preliminary experiments contained a respirable fraction (1-4 µm) of only about 1%.

 Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony therefore has an inherently low exposure potential to the alveolar region of the lung.

Additional data for acute toxicity are available for the following source substances which serve as potential data sources for the analogue approach of Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony:

For the oral as well as for the dermal route, the LD 50 for all available data was found to be at least > 2000 mg/kg bw:

- Source chemical 1 - Fluidized catalytic cracking (FCC) catalysts:

LD50 oral > 31600 mg/kg bw/d (S); Calkins and Ward 1976

LD50 dermal > 2000 mg/kg bw/d (S); Calkins and Ward 1976

- Source chemical 2 - Zeolite, cuboidal, crystalline, synthetic, non-fibrous:

LD50 oral > 5110 mg/kg bw (K); Berthold 1990

LD50 oral > 31600 mg/kg bw (S); WR Grace and Company 1976

LD50 dermal > 2000 mg/kg bw (K); Moore 1974

LD50 dermal > 2000 mg/kg bw (S); WR Grace and Company 1976

- Source chemical 3 - Kaolin, calcined:

LD50 oral > 5000 mg/kg bw (K); Wnorowski 1997

LD50 dermal > 5000 mg/kg bw (K); Wnorowski 1997

- Source chemical 4 - Silicic acid, aluminium salt:

LD50 oral > 2000 mg/kg bw (K); Colas 2009

- Source chemical 5 - Aluminium oxide:

LD50 oral > 15900 mg/kg bw (K); Butter 1969

The available data support the applicability of the selected substances within the analogue approach of Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony.

As the respirability of Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony can be excluded, no data are provided for the source substances for the analogue approach.

The respective references for the source substance data can be found in the data matrix of the justification for the analogue approach, which can be found either in the CSR or as attachment in IUCLID section 13.

Justification for classification or non-classification

Based on the results obtained, Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony does not fulfill the criteria to be classified for acute toxicity according to DSD (67/548/EEC) or CLP (1272/2008/EC).