Registration Dossier
Registration Dossier
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EC number: 231-722-6 | CAS number: 7704-34-9
Carcinogenicity
Administrative data
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
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),
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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