Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Short description of key information:

In accordance with section 1 of REACH Annex XI, the performance of a two-generation study is scientifically not justified.

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. 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 effects on fertility 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 fertility 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 reproduction toxicity studies (effects on fertility and developmental toxicity) with elemental sulfur.

Effects on developmental toxicity

Description of key information

In accordance with section 1 of REACH Annex XI, the performance of a developmental toxicity study is scientifically not justified.

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. 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 effects on developmental toxic 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 developmental toxicity.

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 reproduction toxicity studies (effects on fertility and developmental toxicity) with elemental sulfur.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the EU CLP Regulation (EC No. 1272/2008), classification is not necessary for effects on fertility and developmental toxicity.