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Toxicological information

Carcinogenicity

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Description of key information

NOAEL oral = 1760 mg/kg bw/d (RA to Syloid 244)
NOAEC inhal = 10 mg/m³ (RA to Kaolin)

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
1 760 mg/kg bw/day

Carcinogenicity: via inhalation route

Endpoint conclusion
Dose descriptor:
NOAEC
10 mg/m³

Additional information

There is no data available for aluminatesilicate. However, long-term feeding studies are reported for synthetic amorphous silica (SAS) by Takizawa (Takizawa et al. 1988, RL2). Three groups of rats and mice received Syloid 244 at dietary levels of 1.25, 2.5 and 5% for 103 and 93 weeks, respectively. This corresponded to average daily doses of 2000 mg/kg bw for the high-dose group of rats and to 4500 to 5800 mg/kg bw for the high-dose groups of female and male mice, respectively. The animals were in good condition throughout and showed high survival. The tumour responses in all organs of SAS-treated rats and mice were not statistically significantly different from the controls (Fisher´s exact test and Cochran-Armitage test for trend). Based on the negative results after long-term oral application of SAS, there is no evidence of a carcinogenic potential arising from ingestion of these amorphous minerals.

There is additional data for carcinogenicity which was conducted with the read across substance Kaolin (Wagner, 1987, RL2). None of 40 rats exposed to Kaolin dust at a concentration of 10 mg/m3 for 6 hours per day with exposure durations ranging from 3 months to 12 months showed tumour formation.

Additionally there are several results from epidemiological studies which were also conducted with the read across substance Kaolin supporting the results which were obtained in experimental animals (Altekruse et al. 1984, RL2; Sepulveda et al. 1983, RL2; Kennedy et al., 1983, RL2; Ogle et al. 1989, RL2; Rundle et al., 1993, RL2).

Justification for classification or non-classification

There is no need for classification of aluminatesilicate as carcinogen.