Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

No carcinogenic potential observed with synthetic amorphous aluminum sodium silicate (NAS) in a rat carcinogenicity model after intra-pleural treatment, as well as in a long-term feeding study with structure-analogous silica in mouse and rat and calcium silicate in rats.

Key value for chemical safety assessment

Justification for classification or non-classification

see Discussion above: no carcinogenic potential

Additional information

Negative findings in a rat carcinogenicity model after comparative intra-pleural treatment with various types of materials

(including synthetic amorphous aluminum sodium silicate, NAS) [Unilever 1995] and the absence of a mutagenic potential underline that the cancerogenic potential of synthetic amorphous NAS can be considered as negligible.

Negative results were also found after long-term oral administration of the structure-analogous synthetic amorphous silica (SAS) (up to 5 % in the diet given to rats and mice, corresponding to average daily doses of 2000 mg/kg bw in rats and 4500 to 5800 mg/kg bw in mice, female and male, respectively) [Takizawa et al. 1988].

There was no evidence of a carcinogenic potential in a 2-y feeding study using synthetic amorphous calcium silicate (Columbia 1956, see also 7.5.1).

However, the number of animals was too small as to deliver sufficiently robust results for biostatistical reasons.

In synopsis of all studies, it is concluded that there is no evidence of a carcinogenic potential arising from ingestion of synthetic amorphous sodium aluminum silicates.