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Toxicological information

Carcinogenicity

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Description of key information

SFL is not expected to pose a risk of carcinogenicity.

Key value for chemical safety assessment

Justification for classification or non-classification

No carcinogenicity classification is warranted for SFL according to either the DSD or CLP based on evidence from genotoxicity, repeat dose studies and long term human studies performed on calcium carbonate.

Additional information

All calcium carbonate toxicity studies are considered to be relevant to sugar factory lime (SFL) based on the fact that SFL is primarily composed of calcium carbonate (61.8 - 95.6 %w/w)and other calcium salts. SFL is not classified for human health. Of its components, only calcium oxalate is classified as acutely toxic via the oral and dermal routes (category 4); however, it is present below the concentration limit that would result in classification of SFL. As a result, it is considered that the properties of SFL are governed by those of calcium carbonate.

There are no lifetime animal studies available on calcium carbonate in order to directly investigate its possible carcinogenic activity. However, calcium carbonate gave negative results in the in vitro genotoxicity studies and in repeat dose studies with calcium carbonate (nano) there is no evidence that calcium carbonate is able to induce hyperplasia or pre-neoplastic lesions. Furthermore, the long term human data does not provide any indications of carcinogenicity.

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