Sulfur

Endpoint summary

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 1.2 of REACH Annex XI, testing does not appear to be scientifically necessary as the weight of evidence indicates no concern for reproductive (fertility) effects from sulfur (conclusions from EFSA evaluations on food additives of sulfur-containing substances and EPA assessments for sulfur oxides and Cosmetic Ingredient Review of Sodium Sulfate) and therefore further testing on vertebrate animals is not warranted.

Sulfur is an inorganic element, which in its various forms (elemental, oxidised and reduced) accounts for about 1.9% of the total weight of the earth.  Sulfur-deficient environments are rare in nature with chronic exposure to sulfur being the natural state.  It is generally recognised as safe (40 CFR §180.2) by the US EPA and "since it does not give rise to metabolites other than such are well know to be intermediary or end products of mammalian metabolic reactions, the intent of chronic testing requirements do not apply to elemental sulfur and its possible metabolites."

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. Although sulfur can be absorbed both dermally and orally, it is mainly expected to be rapidly excreted.  In the main, elemental sulfur is expected to be metabolised by plants rather than animals, with human intake of sulfur usually in the form of sulfur-containing amino acids, as well as sulfates and sulfites that may be present in many foods and beverages.  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 weight of evidence looks at the avialable data on the forms of sulfur expected to be relevant to man, i.e. oxides of sulfur, sulfates and sulfites.

Effects on developmental toxicity

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

Toxicity to reproduction: other studies

Additional information

In accordance with Section 1.2 of REACH Annex XI, testing does not appear to be scientifically necessary as the weight of evidence indicates no concern for reproductive (fertility) effects from sulfur (conclusions from EFSA evaluations on food additives of sulfur-containing substances and EPA assessments for sulfur oxides and Cosmetic Ingredient Review of Sodium Sulfate) and therefore further testing on vertebrate animals is not warranted.

Sulfur is an inorganic element, which in its various forms (elemental, oxidised and reduced) accounts for about 1.9% of the total weight of the earth.  Sulfur-deficient environments are rare in nature with chronic exposure to sulfur being the natural state.  It is generally recognised as safe (40 CFR §180.2) by the US EPA and "since it does not give rise to metabolites other than such are well know to be intermediary or end products of mammalian metabolic reactions, the intent of chronic testing requirements do not apply to elemental sulfur and its possible metabolites."

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. Although sulfur can be absorbed both dermally and orally, it is mainly expected to be rapidly excreted.  In the main, elemental sulfur is expected to be metabolised by plants rather than animals, with human intake of sulfur usually in the form of sulfur-containing amino acids, as well as sulfates and sulfites that may be present in many foods and beverages.  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 weight of evidence looks at the avialable data on the forms of sulfur expected to be relevant to man, i.e. oxides of sulfur, sulfates and sulfites.

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.