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Carcinogenicity

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Description of key information

In a 2-y feeding study, no increase in tumors found.  No carcinogenic potential observed with sodium aluminium silicate (NAS) in a rat carcinogenicity model after intra-pleural treatment, as well as in a long-term feeding study with a structure-analogous silica in mouse and rat.

Key value for chemical safety assessment

Additional information

There was no evidence of a carcinogenic potential in a 2-y feeding study using 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.

Negative results were 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].

Negative findings in a rat carcinogenicity model after intra-pleural treatment with various types of materials (including sodium-aluminium silicate, NAS, a structure analogue of calcium silicate) [Unilever 1995] and the absence of a mutagenic potential underline that the cancerogenic potential of synthetic amorphous calcium silicate can be considered as negligible .

In synopsis of all studies, it is concluded that there is no evidence of a carcinogenic potential arising from ingestion calcium silicate.

Justification for classification or non-classification

see Discussion above: no carcinogenic potential