Registration Dossier

Toxicological information

Carcinogenicity

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Description of key information

In accordance with section 1 of REACH Annex XI, a carcinogenicity study does not need to be conducted. Sulfur is not mutagenic (the structure of sulfur raises no chemical alert for mutagenicity or other general reactivity with genetic material) and did not cause hyperplasia and/or pre-neoplastic lesions in the sub-chronic repeated dose toxicity study.

In general, sulfur is an essential element in the metabolism of all living organisms, thus chronic exposure to sulfur is the natural state. More specifically, sulfur is unreactive and insoluble. Systemic effects were absent after subacute and subchronic oral exposure and subacute dermal exposure. Additionally, in vitro and in vivo tests have demonstrated no evidence of genotoxicity. Sulfur is only metabolised by intestinal bacteria; there are indications of absorption of metabolites but which are most likely endogenous to the body (e.g. well known to be intermediary or end products of mammalian metabolic reactions). The expectation that no carcinogenic effects will occur as a consequence of sulfur exposure is supported by the long-standing use of sulfur in topically applied, pharmaceutical formulations and as a pesticide and the absence of carcinogenic effects.

The US-EPA (1991) draws the same conclusion. According to the US-EPA human risks, if any, from both dietary and occupational exposure to sulfur are considered to be very low because of the general knowledge of the chemical, its ubiquitous natural occurrence and its low acute toxicity as well as its long history of use including some pharmaceutical applications. It is therefore considered unnecessary to conduct carcinogenicity studies with elemental sulfur.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In the absence of experimental carcinogenicity data and taking account of the lack of mutagenic activity, classification is not necessary for carcinogenicity under EU CLP Regulation (EC No. 1272/2008),