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EC number: 237-280-0 | CAS number: 13718-59-7
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Report is not reliable, because the study was conducted in house rats captured from poultry houses, the low number of animals per group and because the results showed a very high variability between animals.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of dietary selenium on differentiation, morphology and functions of spermatozoa of the house rat, Rattus rattus L.
- Author:
- Kaur, R.; Parshad, V.R.
- Year:
- 1 994
- Bibliographic source:
- Muta. Res. 309, 29-35
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study investigated the effects of ingestion of 2 ppm and 4 ppm selenium (as sodium selenite) in the diet by the house rat, Rattus rattus, for 5 weeks. Food consumption, body weight gain, testicular and cauda epididymidis weight, concentration, motility and percentage of live spermatozoa and morphology were examined.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- 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
- Details on test material:
- - Name of test material (as cited in study report): sodium selenite
- Molecular formula (if other than submission substance): Na2SeO3
- Molecular weight (if other than submission substance): 172.95
- Substance type: technical product
- Physical state: solid
- Other: sodium selenite purchased from Romali, Bombay
No further information given.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: house rat, Rattus rattus
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: rats captured from poultry houses
- Age at study initiation: mature rats
- Diet (ad libitum): pellets of rat feed in crushed form (CPF) supplied by Lipton India Ltd., Calcutta
- Water: ad libitum
- Acclimation period: 7 - 10 days
No further information given.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on exposure:
- DIET PREPARATION
- Pellets were crushed to ensure proper mixing of the required amount of selenium (as sodium selenite) in the food.
- Group 1: diet without addition of sodium selenite.
- Group 2: diet containing 2 ppm sodium selenite.
- Group 3: diet containing 4 ppm sodium selenite. - Details on mating procedure:
- no mating performed
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 5 weeks
- Frequency of treatment:
- daily
- Details on study schedule:
- not applicable
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2 ppm Se as sodium selenite
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
4 ppm Se as sodium selenite
Basis:
nominal in diet
- No. of animals per sex per dose:
- six male rats per dose group
- Control animals:
- yes, plain diet
- Details on study design:
- no data
- Positive control:
- no data
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: in weekly intervals and on day 36 before necropsy
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
No further information given. - Oestrous cyclicity (parental animals):
- not applicable
- Sperm parameters (parental animals):
- - A portion of the testis was punctured to remove one or two pieces of seminiferous tubule which were placed on a glass slide in a drop of saline solution and covered with a coverslip. The coverslip was pressed delicately to puncture the tubule to release its fluid on the slide. The tubular fluid was mixed with eosin-nigrosine staining solution and kept at 37 °C for 20 min. Similarly, the cauda epididymidis fluid obtained by pressing both caudae after their incision in 0.5 mL saline solution was incubated at 37 °C for 5 min and a drop of this was stained with eosin-nigrosine staining solution at 37 °C for 20 min. Smears of both testicular and cauda epididymidis fluids were drawn on clean, grease-free slides, air-dried and mounted in DPX. Three slides of each rat were studied for morphological abnormalities in different regions of the elongated spermatids and spermatozoa respectively under the light microscope. From each slide, at least 100 spermatozoa were examined, that is about 300 spermatozoa/rat.
- Sperm concentration in millions/mL of each rat was determined from diluted cauda epididymidis fluid with a haemocytometer.
- Sperm motility was estimated by hanging drop method in whole number units from 0 to 4. Zero indicates total immobility and 4 indicates maximum perceived motility; motility less than 2 was considered abnormal.
- Percentage of live spermatozoa was estimated by observing 100-150 spermatozoa from a slide smeared with eosin-stained cauda epididymidis fluid of each rat. Spermatozoa stained pink with eosin were considered dead and transparent ones (unstained) were considered live. - Litter observations:
- not applicable
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: all surviving animals were killed by using chloroform vapour on day 36.
GROSS NECROPSY
- no data
HISTOPATHOLOGY / ORGAN WEIGHTS
- Testes and caudae epididymides were dissected and weighed. - Postmortem examinations (offspring):
- not applicable
- Statistics:
- Statistical significance of the differences between different parameters of control and treated rats was determined by Student’s t-test.
- Reproductive indices:
- not applicable
- Offspring viability indices:
- not applicable
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- not examined
Details on results (P0)
- A significant decrease in body weights was observed in the 2 and 4 ppm groups compared to the control during the first week of treatment.
- Body weights returned to original levels and were maintained during the subsequent 4 weeks of the study.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
Sperm differentiation:
- Treatment with 2 ppm over 5 weeks had no visible adverse effects on any stage of elongated spermatids in comparison to control.
- Several types of abnormalities on the midpiece region of their flagellum were observed at 4 ppm selenium in the diet.
- Abnormal spermatids also showed changes in refractivness of their midpiece, and a few spermatides with multiple abnormalities were found in the 4 ppm group.
Sperm morphology:
- A dose dependent effect of selenium on the morphology of cauda apididymis spermatozoa was observed in comparison to control.
- Percentage of abnormalities related to the midpiece region in the 2 ppm group were statistically significantly (about 3 %) more than in control rats (0.6 %).
- In the 4 ppm group, percentage sperm abnormalities were statistically significantly (about 23%) increased with a highly variable response in individual animals (10-67%).
- Abnormalities in the 4 ppm group were related mainly to the midpiece region, but a statistically significant increased percentage (about 1%) of multiple sperm abnormalities was seen as well (0.02 5 in control).
- Abnormalities were characterised by bending of the proximal, middle and distal parts of the midpiece and bifurcation of proximal midpieces. Bending of midpiece resulted in coiling or torsion of the proximal midpiece.
Sperm functions:
- Sperm concentrations in the cauda epididymis were significantly less in the 4 ppm group compared to the 2 ppm and control groups.
- Sperm motility was adversely affected in the 4 ppm group, but not in the 2 ppm group.
- Significantly and dose-related reductions in the percentage of live spermatozoa were observed in rats of the 2 and 4 ppm groups compared to control.
- Sperm function parameters showed a high variability between rats.
ORGAN WEIGHTS (PARENTAL ANIMALS)
- Testis and cauda epidiymis weights in relation to body weights decreased does dependently in the 2 and 4 ppm groups.
Effect levels (P0)
- Dose descriptor:
- LOAEC
- Remarks:
- (male fertility)
- Effect level:
- 2 ppm (nominal)
- Based on:
- element
- Remarks:
- equivalent to 0.12 mg Se/kg bw/d
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
No information on compound intake is given. Therefore, dose levels in mg/kg bw/d are calculated by using a conversion factor 0.06 for adult male rats of 250 g. Thus, dose level of 0.12 and 0.24 mg/kg bw/d are estimated for the dose groups fed with 2 or 4 ppm Se in the diet group, respectively.
Calculation of LOAEL for ZnSeO3:
molar weight of Na2SeO3: 172.95 g/mol
molar weight ZnSeO3: 192.3672 g/mol
molar weight Se: 78.96 g/mol
--> 0.12 mg Na2SeO3 = 0.13 mg ZnSeO3 --> LOAEL (rat, oral) ZnSeO3 = 0.13 mg/kg bw/d
Applicant's summary and conclusion
- Conclusions:
- Ingestion of 2 and 4 ppm selenium as sodium selenite in the diet by house rats (Rattus rattus) for 5 weeks caused a dose-dependent reduction in body weight, testicular and cauda epididymis weights, concentration, motility and percentage of live spermatozoa with simultaneous increases in the percentage of abnormal forms. Based on these results, the lowest dose level of 2 ppm must be regarded as a low adverse effect level. This LOAEL corresponds to 0.12 mg Se/kg bw/d and can be recalculated to 0.13 mg/kg bw/d ZnSeO3.
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