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EC number: 618-920-1 | CAS number: 93280-40-1
- 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
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- 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
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- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented. Purity of the test substance not stated.
Data source
Reference
- Reference Type:
- publication
- Title:
- Developmental toxicity evaluation of orthovanadate in the mouse
- Author:
- Sanchez, D.; et al.
- Year:
- 1 991
- Bibliographic source:
- Biol. Trace Element Res. 30, 219-226
Materials and methods
Test guideline
- Guideline:
- other: no information available, if a guideline was followed
- Principles of method if other than guideline:
- Evaluation of the effects of vanadate (V5+) when administered once daily by gavage as sodium orthovanadate to mice throughout organogenesis.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Trisodium tetraoxovanadate
- EC Number:
- 237-287-9
- EC Name:
- Trisodium tetraoxovanadate
- Details on test material:
- - Name of test material (as cited in study report): Sodium orthovanadate
- Molecular formula (if other than submission substance): Na3VO4
- Physical state: solid
No further details are given.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals were obtained from Letica (Barcelona, Spain).
- Weight at study initiation: 26-29g
- Housing: mice were housed in solid-bottom plastic cages with stainless steel wire lids.
- Diet: ad libitum, standard laboratory chow
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 45 +/- 5
- Photoperiod: 12 hours dark/light cycle
No further details are given.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- The test substance was dissolved in deionised water. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No details are given.
- Details on mating procedure:
- After acclimatisation, females were mated overnight with adult males of the same strain. The morning on which a copulation plug was detected was considered as day 0 of gestation. At this time, animals were randomly assigned to either the control or the vanadate-treated group.
No further details are given. - Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- once daily on days 6-15 of pregnancy
- Duration of test:
- till day 18 of pregnancy
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
7.5 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
15 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
30 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
60 mg/kg body weight
Basis:
nominal conc.
- No. of animals per sex per dose:
- 14-20 dams per dose group
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: The choice of the dosage levels was based on data from a previous study on the developmental toxicity of vanadyl sulfate in mice (Paternein, J.L.; et al. 1990).
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: general appearance of pregnant mice were monitored daily.
BODY WEIGHT: Yes
- Time schedule for examinations: body weight of pregnant mice were monitored daily.
FOOD CONSUMPTION: Yes
- Time schedule for examinations: Food consumption of pregnant mice were monitored daily.
WATER CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 18 with an overdose of ether.
- All dams were evaluated for body weight, liver and kidney weights.
No further details are given. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of dead and live fetuses: Yes - Fetal examinations:
- - External examinations: all live fetuses were dissected from the uterus and evaluated for body weight, sex and external abnormalities.
- Soft tissue examinations: 1/3 of the fetuses from each litter were placed in Bouin's fluid to be examined for soft tissue abnormalities.
- Skeletal examinations: 2/3 of the fetuses from each litter were cleared and stained with alizarin red S before examination for skeletal malformations and variations.
- Head examinations: No data - Statistics:
- Homogeneity of variance was analysed by Barlett's test. If variances were homogenous, a one-way analysis of variance (ANOVA) was used to test all dose groups simultaneously. The Kruskal-Wallis test was used when variances were not homogenous. Differences between control and orthovanadate-treated groups were analysed by Student's t-test. Incidence data were analysed using the chi-square test. The level of significance for all analyses was p<0.05.
- Indices:
- no details given
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Doses of 30 and 60 mg/kg/day of sodium orthovanadate resulted in maternal toxicity.
- In the high dose group, 17 dams (from 19 pregnant females dosed) died during the treatment period. Consequently, the two remaining dams were not included in the teratological evaluation of orthovanadate.
- At 30 mg/kg/day, 4 dams (from 18 pregnant females does) were found dead during the study.
- Exposure to 7.5 or 15 mg/kg/day of the test substance did not result in any maternal death.
- Maternal weight gain was significantly reduced below control values in the 30 mg/kg/day dose group on gestational days 6-15, whereas food consumption exhibited a significant decrease in the 15 and 30 mg/kg/day dose groups on gestational days 0-18.
- At scheduled termination on gestation day 18, there were no significant decreases in body weight, gravid uterine weight, corrected body weight and change in corrected body weight.
- There was a decrease in absolute and relative liver weight in the 15 mg/kg/days dose group and an increase in relative kidney weight at 30 mg/kg/day, which were statistically significant versus controls. However, the decreases in liver weight were not dose-related and therefore they were not attributed to treatment.
- Evaluation of gestational parameters for the mice indicated no treatment-related effects on number of total implantations per litter, number of live and dead/resorbed fetuses per litter, sex ratio, featl body weights and the number of stunted fetuses.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 7.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes. Remark: skeletal anormalities
Details on embryotoxic / teratogenic effects:
- Sodium orthovanadate did not induce significant incidence of gross and visceral malformations or variations in mouse fetuses.
- Treatment-related changes were found during the examination of the incidence and type of skeletal anormalies: significant decreases in the number of ossified sacrococcygeal vertrebrae, as well as the number of ossified forelimb and hindlimb proximal phalanges
- No significant increases in the number of fetuses with reduced ossification of occipital and parietal bones or sternebrae were observed.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- At 30 and 60 mg/kg body weight, deaths occurred among the dams (4/18 and 17/19). Body weight gain was significantly reduced (approximately 20%) at 15 mg/kg b.w. No differences were reported in final body weight, gravid uterine weight, or corrected body weight.
NOAEL for maternal toxicity: 7.5. mg/kg. b.w./day.
NOAEL for foetotoxicity 15 mg/kg b.w./day. - Executive summary:
Sodium orthovanadate in deionised water was administered once daily by gavage on gestational days 6 -15 to mice at doses of 0, 7.5, 15, 30 and 60 mg/kg body weight/day. Dams were killed on day 18 of pregnancy, and fetuses were examined for external, visceral and skeletal defects. Maternal toxicity was observed at the highest doses levels, as evidenced by a significant number of deaths (60 and 30 mg/kg body weight/day) and reduced weight gain and food consumption (30 and 15 mg/kg body weight/day). Embryolethality and teratogenicity were not observed at maternally toxic doses and below, but fetal toxicity was evidenced by a significant delay in the ossification process of some skeletal districts at 30 mg/kg body weight/day. The NOAEL for maternal toxicity was 7.5 mg/kg body weight/day and 15 mg/kg body weight/day represented a NOAEL for developmental toxicity in mice under the conditions of this study.
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