Aluminum antimony nickel silicon titanium vanadium oxide

Endpoint summary

Additional information

in-vitro:

Data are available for gene mutation in bacteria (Paulus, 2010, RL2). Five concentrations of the test material, suspended in deionised water (ranging from 5010 to 50 µg/plate) were used in the first experiment: Five genetically manipulated strains of Salmonella typhimurium (TA 97a, TA 98, TA 100, TA 102 and TA 1535) were exposed to the test material both in the presence and in the absence of a metabolic activation system (S9 mix) for 48 hours, using the plate incorporation method. None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. The test item did not show any mutagenic effects in the first experiment. No signs of toxicity towards the bacteria could be observed. The sterility control and the determination of the titer did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range.All positive controls showed mutagenic effects with and without metabolic activation. To verify the results of the first experiment, a second experiment was performed, using five concentrations of the test item (ranging from 5006 to 314 µg/plate) and a modification in study performance (pre-incubation method). The test item did not show mutagenic effects in the second experiment, either. No signs of toxicity towards the bacteria could be observed. The sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range.All positive controls showed mutagenic effects with and without metabolic activation. Under the experimental conditions of the test, the test item did not show mutagenic effects towards Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535. Therefore, under the experimental conditions chosen, no concentration-effect relationship could be determined and the test material is considered as not mutagenic in bacteria.

 

No data for gene mutation in mammalian cells are available for the target substance Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony. Therefore, data from the analogue approach source substance Zeolite cuboidal were applied to cover the endpoint gene mutation in mammalian cells for the target substance:

A mouse lymphoma assay in L5178Y cells was conducted according to OECD Guideline 476 with a Ag modified surface Zeolite,cuboidal, crystalline, synthetic, non-fibrous (Zeostop X) (Fellows 1999, RL2). When tested up to and including cytotoxic doses, i.e., without S-9 at 2.5-40 µg/ml and with S-9 at 10-160 µg/ml, the Zeolite (Zeostop X) did not induce mutation at the tk locus of L5178Y mouse lymphoma cells in two independent experiments, with or without S9 mix. The positive controls were functional.

 

in-vivo:

An in-vivo study is available with a not surface modified Zeolite, cuboidal, crystalline, synthetic, non-fibrous (FDA 71-75) (NTIS, 1974, RL2). Albino rats were used for the evaluation of cytogenetic effects of Zeolite (FDA 71-75) in vivo in a Mammalian Bone Marrow Chromosome Aberration Test (OECD 475). A single dose as well as repeated dosing (5 consecutive days) were employed. The test substance was administered orally by intubation at concentrations of 4.25, 42.5, 425, and 5000 mg/kg bw.Metaphase chromosomes spreads were prepared from the bone marrow and scored for chromosomal aberrations. Neither the variety nor the number of chromosomal aberrations in bone marrow from the dosed animals differed significantly from the negative controls. A positive response was observed in bone marrow from animals treated with the positive control triethylene melamine. The test compound was considered as non-mutagenic as measured by this assay.

 

Additional data for genetic 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:

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

gene mutation in bacteria: negative; Simmon and Eckford 1979

- Source chemical 4 - Silicic acid, aluminium salt:

gene mutation in bacteria: negative; Paulus 2010

In accordance with the target substance, the available data for the source substances also provide negative results for genetic toxicity.

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.

 

Short description of key information:
in-vitro:
- gene mutation in bacteria: negative
- gene mutation in mammalian cells: negative (RA Zeolite cuboidal)

in-vivo:
- chromosomal aberration in-vivo: negative (RA Zeolite cuboidal)

Endpoint Conclusion: No adverse effect observed (negative)

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 genetic toxicity according to DSD (67/548/EEC) or CLP (1272/2008/EC).