Registration Dossier

Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

Although no carcinogenicity study seems to be required for potassium sulphate as the substance is not genotoxic, a reliable chronic/carcinogenicity study is available for ammonium sulphate. No evidence of a carcinogenic potential was observed in this study with rats following closely the requirements of OECD testguideline 453.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
284 mg/kg bw/day

Justification for classification or non-classification

Potassium sulphate does not have to be classified for carcinogenicity according to the Directive 67/548/EC or CLP Directive.

Additional information

No carcinogenicity study is available with potassium sulphate neither required as the substance is not genotoxic. However, a chronic oral toxicity and carcinogenicity study was conducted in rats, similar to the requirements of OECD Testguideline 453 with ammonium sulphate. For investigation of the carcinogenic potential, groups of 50 rats/sex were fed a diet containing the test substance at concentrations of 0, 1.5, or 3% for 2 years. These concentrations corresponded to average daily intakes of 0, 564.1, and 1288.2 mg/kg bw/d for males and 0, 4649.9, and 1371.4 mg/kg bw/d for females respectively.

Absolute and relative kidney weights were increased at the high dose level for both sexes. Absolute spleen weights were decreased and relative liver weights were increased in high dose males. No macroscopic changes were recorded by gross pathology, except for massive nodular or focal lesions suggesting neoplastic changes. At histopathological examination, non-neoplastic and neoplastic lesions were noted in the control and treatment groups, with no significant inter-group difference in their incidences or severity.

The authors concluded that the no observed adverse effect level of ammonium sulfate was the 0.6% diet, which is equivalent to 256 and 284 mg/kg bw/d in males and females, respectively, and the compound is noncarcinogenic under the conditions of the study. There was no evidence of a long-term carcinogenic activity of the test substance.