Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-722-6 | CAS number: 7704-34-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of 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 known 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 available data on the forms of sulfur expected to be relevant to man, i.e. oxides of sulfur, sulfates and sulfites.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final Amended Safety Assessment of Sodium Sulfate as Used in Cosmetics
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 2 016
- Bibliographic source:
- Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200, Washington, DC 20036-4702
Materials and methods
Test guideline
- Guideline:
- other: review of tests by various methods on different sulphur containing substances
- GLP compliance:
- no
- Remarks:
- Review article; GLP not applicable
Test material
- Reference substance name:
- Sulfur
- EC Number:
- 231-722-6
- EC Name:
- Sulfur
- Cas Number:
- 7704-34-9
- Molecular formula:
- S
- IUPAC Name:
- sulfur
- Test material form:
- solid
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Remarks on result:
- other: No adverse effects on reproduction parameters expected for sulfur containing compounds
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: No adverse effects on reproduction parameters expected for sulfur containing compounds
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Executive summary:
The CIR panel noted that there were no abnormal results for reproductive and developmental endpoints for rats administered Sodium Sulfate by gavage at dose rates up to 1000 mg/kg/day. NOEL for reproductive/developmental toxicity endpoints was 1000 mg/kg/day.
An OECD guideline 421 screening study was conducted on Wistar rats at doses of 0, 100, 300 and 1000 mg/kg/day administered by oral gavage. Animals (both sexes, 10 rats/sex/group) were dosed for 14 -days pre-pairing, for the duration of parining (up to 14 days) and either 1 day before necropsy after at least 28 days (males) or 4 days post partum (females). No effects on either general toxicity or reproductive parameters (including reproductive function (sperm measures), reproductive performance, fertility index, conception rate, duration of gestation, corpora lutea count, implantation rate, post-implantation loss, duration of gestation, and litter size) were noted and the NOEL was set at 1000 mg/kg/day.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.