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Diss Factsheets
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EC number: 237-048-9 | CAS number: 13597-46-1
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Report is reliable with restriction, and regarded as sufficient for evaluation of the embryo-/foetotoxic and teratogenic potential of sodium selenite.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of sodium selenite on methylmercury embryotoxicity and teratogenicity in mice.
- Author:
- Nobunaga T, Satoh H, Suzuki T.
- Year:
- 1 979
- Bibliographic source:
- Toxicol.Appl. Pharmacol.47, 79-88
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female mice were given drinking water containing sodium selenite (3 ppm and 6 ppm selenium) at two different dose levels for approximately 1 month before gestation and thereafter up to day 18 of gestation. Examinations were undertaken to evaluate effects of the test item on female fertility and embryo-/foetotoxicity and teratogenicity.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 26970-82-1
- Cas Number:
- 26970-82-1
- IUPAC Name:
- 26970-82-1
- Reference substance name:
- Sodium selenite
- EC Number:
- 233-267-9
- EC Name:
- Sodium selenite
- Cas Number:
- 10102-18-8
- Molecular formula:
- H2O3Se.2Na
- IUPAC Name:
- disodium selenite
- Reference substance name:
- disodium selenite pentahydrate
- IUPAC Name:
- disodium selenite pentahydrate
- Details on test material:
- - Name of test material (as cited in study report): sodium selenite, pentahydrate
- Molecular formula (if other than submission substance): Na2SeO3 * 5H20
- Molecular weight (if other than submission substance): 263.01 g/mol
- Substance type: technical product
- Physical state: solid
No further details are given.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- mouse
- Strain:
- other: IVCS
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 60 days
- Housing: housed 4 or 5 per cage during the precoital period and 1 to 2 per cage during gestation, in plastic cages with wood chips for bedding.
- Diet: ad libitum; food was a dough made from a commercial-chow for mice.
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-26
- Photoperiod: 14 hours light/ 10 hours dark cycle
No further details are given.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- The test substance was dissolved in water to obtain a 0.03% solution.
DIET PREPARATION
- The diet-chow used did not contain any measurable amounts of selenium when measured by the Watkinson's method (sensitivity: 0.13 nmol/g). - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- After 30 days, as mice came into pro-oestrus, they were individually mated overnight with a healthy non-treated male mouse of the same strain. If female mice did not mate during the first overnight trial, they were separated from the males and maintained on experimental feed until next pro-oestrus. Mating trials were terminated on Day 56 after the start of the experiment.
- Impregnation procedure: cohoused
- M/F ratio per cage: 1/1
- Length of cohabitation: overnight
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 30 days prior to gestation until GD 18
- Frequency of treatment:
- daily, continuously in drinking water
- Duration of test:
- until day 18 of gestation
- No. of animals per sex per dose:
- 3 groups including one control group:
- Low dose group: 14 animals
- High dose group: 10 animals
- Control group: 14 animals - Control animals:
- yes
- Details on study design:
- - Dose selection rationale: in previous studies concentrations of selenium around 25-38 nmol/mL (2-3 ppm as selenium) induced mild or severe toxic effects in long-term experiments (Schroeder and Mitchener, 1971 a, b; Palmer and Olson 1974).
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: every third day in the precoital experimental period.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- The amount of food consumed in each cage was determined by measuring the decrease in weight of preweighed feed.
- The loss of weight of feed due to water evaporation was calculated as 8% per day.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: water consumption was determined by measuring the decrease in volume of premeasured water in feeding bottles.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 18
- Organs examined: uterus
OTHER:
- Oestrus cycles of mice were determined by vaginal smears which were sampled with physiological saline, dried on glass slides, and stained with Giemsa solution were examined microscopically every morning. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of total implantations: Yes
- Number of surviving foetuses, dead foetuses, dead embryos, resorptions and implantation sites
- Litter size was defined as the number of surviving foetuses per dam. - Fetal examinations:
- The surviving foetuses were killed by ether or decapitation and examined under a dissecting microscope for gross abnormalities. After dissection of internal organs and tissues, the foetuses were prepared for skeletal examinations by the method of Dawson (1926).
- External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: No data - Statistics:
- t-test
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
WATER CONSUMPTION
- Water consumption was statistically significantly decreased in comparison to control during the precoital period, but not from GD 3-18.
FOOD CONSUMPTION
- No effects on food consumption were observed in comparison to the control group.
BODY WEIGHTS
- No effects on body weight were observed during the precoital or gestation period.
OTHERS
- Oestrus cycle length was increased by about 11.8% in comparison to control in the high dose group (6 ppm), but not in the low dose group (3 ppm).
- Conception rates were 90, 86 and 100% in the control low and high dose groups, respectively.
- The average time until conception showed no significant differences from control.
Effect levels (maternal animals)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
EMBRYO-/FETOTOXICITY
- There were no effects on the number of implantation sites, resorptions, total implants per mother, litters, dead embryos and foetuses in comparison to the control group.
- The number of surviving foetuses and percentage in relation to total implants were not significantly lower than control.
- Foetal body weight was statistically significantly lower in high dose animals (6 ppm), but not in the low dose (3 ppm) compared to controls.
TERATOGENICITY
- The incidence of gross malformations and skeletal anomalies was not affected by treatment.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 0.6 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- not measured/tested
- Remarks:
- No information on test compound intake is available. Therefore, the dose levels in mg/kg bw/d are calculated base on an average water consumption for a 25 g mouse of 5 ml per day. Thus, the dose levels of 0.6 mg/kg bw/d for Na2SeO3 x 5 H2O is calculated for the 3 ppm dietary levels.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No information on test compound intake is available. Therefore, the dose levels in mg/kg bw/d are calculated base on an average water consumption for a 25 g mouse of 5 ml per day. Thus, the dose levels of 0.6 and 1.2 mg/kg bw/d for Na2SeO3 x 5 H2O are calculated for the 3 and 6 ppm dietary levels.
Calculation of NOAEL for selenium based on molecular weights:
molar weight Na2SeO3 x 5H2O: 263.01 g/mol
molar weight Se: 78.96 g/mol
--> 0.6 mg Na2SeO3 x 5H2O = 0.18 mg Se --> NOAEL (mice, oral) = 0.18 mg Se/kg bw/d
Applicant's summary and conclusion
- Conclusions:
- Treatment of female mice with sodium selenite (pentahydrate) in drinking water (3 and 6 ppm Se) for 30 days before gestation and following mating until day 18 of gestation did not cause maternal toxicity, but oestrus cycle length was increased in comparison to control in the high dose group (6 ppm). Beside a statistically significant decrease in foetal body weights in high dose animals (6 ppm), no further signs of embryo-/foetotoxicity or teratogenicity were observed. Thus, the lower dose level of 3 ppm represents a NOAEL. This corresponds to 0.6 mg/kg bw/d Na2SeO3 x5 H2O.
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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