Aluminum antimony nickel silicon titanium vanadium oxide

Carcinogenicity

Description of key information

rat (oral, chronic): not carcinogenic, NOAEL = 60 mg/kg bw/d, highest dose tested (RA Zeolite cuboidal)

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion

Dose descriptor:

NOAEL

60 mg/kg bw/day

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

Additional information

No data for carcinogenicity 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 carcinogenicity for the target substance.

 

In an oral chronic toxicity study (Gloxhuber et al. 1979, RL2) male and female Wistar rats were fed at 0, 10, 100 and 1000 ppm of Zeolite, cuboidal, crystalline, synthetic, non-fibrous (Sasil, corresponding to about 0.6, 6.0 or 60 mg/kg bw/day) in the diet for 104 weeks (50 animals per dose group and sex).Analyses of the test substance concentrations in the diet were difficult due to the high concentrations of aluminum and silicon naturally occurring in rat diets. Body weights and mortality rates of the treated groups were not significantly different from the control group.No carcinogenic effects were observed. In animals dying during the test or killed due to their poor condition, the main causes were basophilic adenoma and adenocarcinoma of the pituitary gland, adenoma and fibroadenoma of the mammary glands, subcutaneous fibroma and some tumours of the genital tract. No significant incidence of a particular type of tumour or spontaneous mortality was evident in any group. No treatment-related findings were seen in any of the organs examined histologically and there was no indication of any treatment-related induction of neoplasms. Comparison of the separate sums of tumour changes observed in the 1000 ppm Zeolite (Sasil) and control groups showed no significant differences between the groups in the frequency of tumours.

 

Additional data for carcinogenicity after inhalation 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 5 - Aluminium oxide (Gross et al. 1973)

- Source chemical 6 - Kaolin (Wagner 1987)

There was no evidence for a carcinogenic effect. However, as the inhalation route is not relevant for the target substance, the data are not considered relevant.

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.