Registration Dossier

Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

Overall,  there is no evidence of treatment-related carcinogenicity in rats administered potassiumchlorider up to 1820 mg/kg bw/day via food over a period of 2 years.

Key value for chemical safety assessment

Justification for classification or non-classification

Based on the availble data no classification/labelling is proposed.

Additional information

oral application

In a long term study performed with KCl, no carcinogenic effects were observed in male rats, Groups of 50 male F344/Slc rats were fed KCl in the diet at levels of 110, 450, 1820 mg/kg bw/day for 2 years. A comprehensive examination of the tissue revealed no evidence of treatment related carcinogenicity. Among non-tumerous lesions nephrotic lesion was predominant in all treatment groups as well as in the control group. In tumerous lesions testicular tumour (interstititial cell tumour) developed with a high incidence in all groups including controls. However, the incidence and type of tumour in experimental and control groups were comparable to those of sponateous tumours in the test organism (Imai 1961, UNEP 2003)

In an other study male and female Wistar rats were fed diets containing 0 or 3 % KCL over a total period of 30 months: Examination after 13 weeks (10 rats/sex/group), after 18 months (15 rats/sex/group) and after 30 months (50 rats/sex /group). Due to the reduction of feed intake the mean test substance intake and mean body weight decreased in time. After 30 months treatment, histopathologically in the adrenals, zona glomerulosa: hypertrophy in 24/50 treated rats versus 4/50 in controls, and in the urinary bladder: cystitis (males: 3/59; females 3/50) and single epithelial hyperplasia (males 3/50; females 2/50)were the only observed changes (Lina 1994, 2004)

Overall, there is no evidence of treatment-related carcinogenicity in rats administered potassiumchlorider up to 1820 mg/kg bw/day via food over a period of 2 years

Categories Display