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Diss Factsheets
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EC number: 231-820-9 | CAS number: 7757-82-6
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The study R. Ceccatelli 2010, is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item Sodium Sulphate to rats. Sodium Sulphate was administered in highly purified water as vehicle at dosages of 100, 300, and 1000 mg/kg body weight/day, and controls received the vehicle only. Sodium Sulphate was administered to male rats for at least 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. In absence of any effect the general NOEL (No Observed Effect Level) was established at 1000 mg/kg/day. As no effects were observed, the NOEL (No Observed Effect Level) for reproduction/ developmental toxicity was considered to be 1000 mg/kg/day.
Short description of key information:
Based on OECD 421 As no effects were observed, the NOEL (No Observed Effect Level) for reproduction/ developmental toxicity was considered to be 1000 mg/kg/day.
Effects on developmental toxicity
Description of key information
Based on OECD 421 as no effects were observed, the NOEL (No Observed Effect Level) for reproduction/ developmental toxicity was considered to be 1000 mg/kg/day.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The study R. Ceccatelli 2010 is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item Sodium Sulphate to rats. Sodium Sulphate was administered in highly purified water as vehicle at dosages of 100, 300, and 1000 mg/kg body weight/day, and controls received the vehicle only. Sodium Sulphate was administered to male rats for at least 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. In absence of any effect the general NOEL (No Observed Effect Level) was established at 1000 mg/kg/day. As no effects were observed, the NOEL (No Observed Effect Level) for reproduction/ developmental toxicity was considered to be 1000 mg/kg/day.
Seidenberg et al., 1986 examined the developmental effects of sodium sulfate in the mouse as part of a validation effort of a developmental screening test. The test substance was administered (2800 mg/kg/day) by gavage on gestation days 8 through 12. No mortality, an unchanged average weight gain, and normal number of litters and neonates/litter were found. A 100 % perinatal survival was found, with an increased postnatal weight at day 1, normal weight at day 3 in the absence of externally visible abnormalities. In second paper of Seidenberg et al, 1987 the results are summarised of this validation test, the outcome of the screening test was considered positive for sodium sulfate, based solely on the increased postnatal weight on day 1 post-partum. However, the significance of such an effect, in the absence of any other effect, is unclear and the reasons for taking this as a positive result are not given.
A developmental / teratogenicity study from P&G (1976) was designed to evaluate the embryotoxic and teratogenic potential of sodium sulphate and a mixture with sodium sulphate. The two test substances when administered to albino rats by oral intubation from Day 6 through Day 12 (13 day sacrifice) or through Day 15 (19 day sacrifice) of gestation at levels of 160 mg/kg bw per day of the test substance of concern (test substance 1, sodium sulphate) and at levels of 50, 100, and 200 mg/kg bw per day of the other tested substance (test substance 2, mixture).
Criteria evaluated for compound effect included maternal body weights, weight gain, food consumption, appearance and behavior, survival rates, pregnancy rates, and reproduction data; and embryo and fetal viability and development.
No effects attributable to the administration of either test substance were noted in comparisons of maternal body weight and food consumption values, appearance and behavior, survival rates, pregancy rates, or implantation efficiencies. In addition, no compound-related differences were noted in evaluations of embryo or fetal viability, or fetal size, sex, and development. Therefore, test substance 1 (Sodium sulphate), when administered to rats at a level of 160 mg/kg, and test substance 2 (mixture with sodium sulphate), when administered to rats at a level up to 200 mg/kg, were considered to be non-teratogenic and non-embryotoxic.
In the study of Arcuri and Gautieri 1973 reported teratogenic effects of morphine sulfate, atropine sulfate and physostigmine sulfate, sodium sulfate served as anion control, with sodium chloride as negative control. The study was well documented, with various endpoints (clinical observations, maternal weight ratio, uterine left/right horn fetal ratio and resorption ration, fetal weight, sex ratio, skeletal abnormalities, soft tissue abnormalities, more specifically exencephaly, cryptorchid test and axial skeletal fusions, but covered only the 8-9 day period of gestation for exposure and the dose of 60 mg/kg was relatively small. There was a statistically significant increase in skeletal abnormalities, described as delayed ossification in the phalanges, sternebrae and skull. Such variations are quite common in tests with rodents and, in the absence of skeletal malformations, generally not regarded as indicative of developmental toxicity. No abnormalities for any of the other endpoints were reported.
Justification for classification or non-classification
The available data give no indication that sodium sulfate is toxic for reproduction. With regard to the natural occurrence of the substance in the body, developmental toxicity is also very unlikely. Sodium sulphate should not be classified for reproduction and developmental toxicity.
Based on the results of the reproduction/developmental screenings test and the developmental toxicity/teratogenicity studies, sodium sulphate does not need to be classified for toxic to reproduction according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (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.
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.
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