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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 236-293-9 | CAS number: 13283-01-7
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- male reproductive system
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Assessment of the Effects Following Subchronic Dosing with Sodium Tungstate on Male Reproductive System in Wistar Rats
- Author:
- Pandey G. et al.
- Year:
- 2 011
- Bibliographic source:
- Recent Research in Science and Technology 3(11), 55-60
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Sodium tungstate was orally administrated to male Wistar rats at a dose level of 50 mg/kg bw/day for 60 days to investigate the effects of sodium tungstate on male reproductive system
- GLP compliance:
- not specified
- Remarks:
- it was not identified by the authors if the study was GLP compliant
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 600-275-2
- Cas Number:
- 10213-10-2
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL FORM
- solid: particulate/powder
DETAILS ON TEST MATERIAL
- Name of test material (as cited in study report): Sodium tungstate
- Other: purchased from Merck India Ltd., Mumbai, India
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 170 - 200 g
- Housing: standard rat cages
- Diet (e.g. ad libitum): standard laboratory chow, ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +/- 3
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The daily dose of the chemical was dissolved in 0.5 mL of distilled water - Details on mating procedure:
- Fertility Test:
Male rats were introduced to parous females, 170-200 g (male:female ratio 1:2) at 55 days of treatment. The successful mating was confirmed in the forthcoming mornings from 56 to 61 days by vaginal plug and spermatozoa in the vaginal smear. The inseminated females were seperated and allowed to deliver at term. The number of pups delivered and their characterictis were noted. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 60 days
- Frequency of treatment:
- daily
Doses / concentrations
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Group A: control rats received 0.5 mL/day of distilled water
Group B: rats treated with Sodium tungstate dihydrate - Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: before the beginning of treatment, at weekly intervals, and at the end of treatment
FOOD CONSUMPTION: Yes
Food consumption was monitored daily, water containers were checked each day and protected from light - Sperm parameters (parental animals):
- Parameters examined in [P] male parental generation: The testes, epididymides, vas deferens, seminal vesicles and ventral prostate, and adrenal removed, cleared of the adhering connective tissue and weighed. Testes and epididymis were assayed for protein, sialic acid, glycogen and cholesterol. Fructose in seminal vesicle was also estimated. Blood samples were collected for estimations of serum testosterone, follicle stimulating hormone and Luteinizing Hormone. Spermatozoa from cauda epididymis were counted. Total sperm Number and cauda epididymal sperm counts were determined. For sperm motility, one drop of evenly mixed sample was applied to a glass slide under a cover glass, percent motility was determined by counting both motile and immotile spermatozoa per unit area. Mean seminiferous tubular diameter was determined and diameter of Leydig cells nuclei were measured.
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in [F1] offspring: The number of pups delivered and their characteristics were noted following [WHO, 1983. Protocol MB-50, A Method for Examining the Effect of the Plant Extracts Administered Orally on the Fertility of Male Rats 9914E. World Health Organization, Geneva]. - Postmortem examinations (parental animals):
- SACRIFICE / GROSS PATHOLOGY
- Male animals: All surviving animals were weighed and autopsied under light ether anesthesia 24h after the last dose of treatment.
HISTOPATHOLOGY:
Testes were fixed in Bouin`s fluid. Paraffin section were cut (5 µm) and stained with hematoxylin and eosin. Mean seminiferous tubular diameter was determined by measuring 100 round sections of seminiferous tubule with the help of ocular micrometer. Diameter of Leydig cells nuclei were measured at x 800.
ORGAN WEIGHTS
The testes, epididymides, vas deferens, seminal vesicles and ventral prostate, kidney, adrenal and liver were removed, cleared of the adhering connective tissue and weighed.
TISSUE BIOCHEMISTRY:
Testes, epididymis and accessory sex organs were frozen at -20 °C for the biochemical estimations. Testes and epididymis were assayed for protein, sialic acid, glycogen and cholesterol. Fructose in seminal vesicle was also estimated.
RADIOIMMUNOASSAY:
Blood samples were also collected for estimations of serum testosterone by radioimmunoassay. Follicle-stimulating hormone and Luteinizing hormone - Statistics:
- Data are expressed as mean ± S.E.M. One-way analysis of variance (StatPlus, 2007) was used for statistical comparison.
- Reproductive indices:
- Fertility of male rats was assesed by the incidence of pregnancy in females
Epididymal sperm concentration and motility:
Spermatozoa from cauda epididymis were counted. One hundred milligram of the epididymis was finely minced with anatomical scissors in 1 mL of physiological saline, placed in a rocker for 10 min then allowed to sit at room temerpature for 2 min. Total sperm number was determined by using a hemocytometer. For sperm motility, one drop of evenly mixed sample was applied to a glass side under a cover glass. The percent motility was determined by counting both motile and immotile spermatozoa per unit area.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs of toxicity were observed
- Mortality:
- no mortality observed
- Description (incidence):
- No deaths were observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The growth and general appearance of the test item treated animals was normal throughout the experiment. The test item did not cause any significant adverse effect on the body weight of treated rats.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Treatment with the test item produce non significant depletion in protein, glycogen and sialic acid content in testis and epididymis and fructose level in seminal vesicle. Cholesterol level of testes and epididymides was non significantly increased.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Treated groups were essentially normal, containing only incidental microfocal lesions of seminiferous or epididymal tubule. Spermatogenesis does not appear to be affected. No change in diameter of seminiferous tubular and number of Leydig cells. There were no histopathological changes ofound in cauda epididymis of treated rats.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- Non-significant reduced sperm count and sperm motility in cauda epididymis
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No significant change in the fertility of male rats as assessed by the incidence of pregnancy in females.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no adverse effects observed
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: this study was designed to assess the effects of the treatment on the male reproductive organ
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Table 1: Effect of the test item treatment on the body and organ weight of male albino rats
Body weight (g) | Reproductive organs weight (mg/100 g body weight) | Vital organ weight (mg/100 bd.wt) | ||||||||
Treatment | Initial | Final | Testes | Epididymides | Ventral prostate | Seminal vesicle | Vas deferens | Kidney | Adrenal | Liver |
Group A, control (vehicle-treated) | 173.75 ±5.66 | 201.87 ±4.33 | 1174.50 ±43.84 | 497.51 ±62.56 | 283.08 ±16.63 | 401.31 ±14.95 | 104.58 ±4.75 | 590.97 ±21.36 | 22.43 ± 1.02 | 3229.53 ± 72.25 |
Group B, 50 mg/kg body weight/day for 60 days | 172.5 ±2.84 | 221.62 ±3.54 | 1089.08ns ±19.4 (p<0.125) | 474.03ns ±10.32 (p<0.2119) | 267.57ns ±10.81 (p<0.5036) | 395.59ns ±8.36 (p<0.759) | 98.34ns ±2.61 (p<0.271) | 550.17ns ±11.61 (p<0.137) | 19.92 ns ±1.12 (p<0.189) | 3183.75ns ± 71.88 (p<0.669) |
Data are expressed as Mean ± SEM of eight animals. ANOVA analysis of variance; Groups B was compared with Group A, a Highly
significant (p≤ 0.0001) ; b Significant (P≤.001); ns non significant
Table 2: Effect of the test item treatment on tissue biochemistry of male albino rats
Cholesterol (mg/g) | Sialic acid (mg/g) | Glycogen (mg/g) | Total protein (mg/g) | Fructose | |||||
Treatment | Testes | Epididymides | Testes | Epididymides | Testes | Epididymides | Testes | Epididymides | Seminal vesicle |
Group A, control (vehicle-treated) | 4.98 ± 0.30 | 4.72 ± 0.17 | 4.63 ± 0.16 | 4.51 ± 0.16 | 3.34 ± 0.14 | 3.96 ± 0.13 | 194.37 ± 6.81 | 198.12 ± 8.59 | 3.12 ± 0.21 |
Group B, 50 mg/kg body weight/day for 60 days | 5.06ns ± 0.21 (p<0.801) | 5.03ns ± 0.04 (p<0.110) | 4.45ns ± 0.15 (p<0.446) | 4.35ns ± 0.20 (p<0.5461) | 3.13ns ± 0.15 (p<0.178) | 3.39ns ± 0.17 (p<0.127) | 192.63ns ± 5.57 (p<0.855) | 197.37ns ± 5.07 (p<0.941) | 3.20ns ± 0.12 (p<0.737) |
Data are expressed as Mean ± SEM of eight animals. ANOVA analysis of variance; Groups B was compared with Group A, highly significant (p≤ 0.0001) ; b
Significant (P≤.001); ns non significant
Table 3: Effect of Sodium tungstate treatment on serum testosterone, serum FSH, serum LH, cauda epididymis sperm analysis, fertility test and
morphometry of male albino rats
Treatment | Serum testosterone (ng/L) | Serum FSH (ng/mL) | Serum LH (ng/ml) | Sperm count (million/mm3) | Motility (%) Cauda epididymis | Fertility test (%) | Seminiferous tubule diameter (µm) | Leydig cell nuclei diameter (µm) |
Group A, control (vehicle-treated) | 4.06 ± 0.11 | 112.87 ± 1.39 | 4.04 ±0.057 | 44.14 ±0.628 | 63.33 ±1.27 | 93.75 | 258.12 ±4.79 | 6.07 ±0.089 |
Group B, 50 mg/kg body weight/day for 60 days | 3.95ns ±0.10 (p<0.4745) | 108.25ns ±1.164 (p<0.381) | 3.93ns ±0.063 (p<0.212) | 42.95ns ±0.66 (p<0.2094) | 60.31ns ±1.69 (p<0.172) | 87.5 | 248.12ns ±4.29 (p<0.1343) | 5.93ns ±0.13 (p<0.383) |
Data are expressed as Mean ± SEM of eight animals. ANOVA analysis of variance; Groups B was compared with
Group A, a Highly significant (p≤0.0001); b Significant (P≤.001); ns non significant
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test item (50 mg/kg bw/day) did not cause any severe histological and biochemical alteration in male reproductive system and thus the NOAEL can be considered to be 50 mg/kg bw/day.
- Executive summary:
In a subchronic repeated dose toxicity study with focus on the male reproductive system, Sodium tungstate dihydrate was administered daily to male Wistar rats by oral gavage at dose levels of 0 and 50 mg/kg bw/day for a total of 60 days. Treated males were mated with untreated females after 55 days of treatment, which were then allowed to deliver their offspring at term.
No deaths or any other clinical signs of toxicity were observed. No effects were seen on body or organ weight. Although there was a non-significant reduction in sperm count and sperm motility in cauda epididymis, there was no significant change in the fertility of male rats. Treated rats showed essentially normal histopathology. There was a non-significant reduction in protein, glycogen and Sialic acid content of testes and epididymides, in fructose levels in the seminal vesicle, and in serum testosterone levels, FSH and LH levels. The cholesterol content of testes and epididymides was non-significantly increased after the administration of sodium tungstate. Overall, results in the study do not indicate that Sodium tungstate dehydrate exposure resulted in direct male reproductive toxicity in the rat. Based on the results from this study the NOAEL can be considered to be 50 mg/kg bw/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.