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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Neurobehavioral effects of sodium tungstate exposure on rats and their progeny
- Author:
- McInturf S.M. et al.
- Year:
- 2 008
- Bibliographic source:
- Neurotoxicol. Teratol. 30(6), 455-461
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EPA OPPTS 870.3650 "Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Study, OECD 422
- Deviations:
- yes
- Remarks:
- The protocol was extended beyond the minimum 54 days of treatment to accomodate evaluation of the development of the offspring through postnatal day 20 as well as their dams following the last dose on day 70.
- 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:
- - Name of test material (as cited in study report): Sodium tungstate dihydrate
- Source: Fisher Scientific
- Analytical purity: > 98%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories (Wilmington, MA)
- Age at study initiation: 8 weeks
- Housing: The adults (e.g., P1) were singly housed (except during mating)
- Acclimation period: 14 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionized water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The powder readily dissolved in a deionized water (diH2O) vehicle for the concentrations used in this study at 5 mg/mL and 125 mg/mL. The solution was concentrated to administer a volume of 1 mL/kg body weight not to exceed 2 mL. Fresh solution was made daily and administered via oral gavage
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Concentrations of the tungstate anion were determined using inductively coupled plasma mass spectrometry (ICP-MS).
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: not specified
- Length of cohabitation: 14 days
- Verification of same strain and source of both sexes: not specified
- Proof of pregnancy: vaginal plug referred to as day 1 of pregnancy - Duration of treatment / exposure:
- 70 days
- Frequency of treatment:
- daily pre- and postnatal exposure
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 mg/kg bw/day
- Dose / conc.:
- 125 mg/kg bw/day
- No. of animals per sex per dose:
- 40
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- In order to ensure a total of 70 days exposure, adults were dosed for any additional days necessary following weaning. Prenatal pup exposure was from sodium tungstate crossing through the placenta and postnatal exposure was indirect via dams' milk.
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Throughout the exposure period, dams and the males used for mating were observed for clinical signs of toxicity.
BODY WEIGHT: Yes
- Time schedule for examinations: Pregnant dams were weighed on gestation days (GD) 1, 10, 15 and 20, and gestational weight gain and gestation length were recorded.
OTHER: N/A - Ovaries and uterine content:
- no data
- Fetal examinations:
- - External examinations: No data
- Soft tissue examinations: Yes: control and high dose pups
- Skeletal examinations: No data
- Head examinations: Yes - Statistics:
- All measures were analyzed using ANOVA. Repeated measures ANOVA were used where appropriate. All animals in the pre-weanling litter were tested for righting reflex and separation distress so the litter was used as the unit of analysis for the ANOVA. The fiducial limit was p< 0.05 and post-hoc comparisons were performed using Tukey's HSD analysis for pair-wise comparisons as appropriate.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects: yes
Details on maternal toxic effects:
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS):
A statistically significant difference was found in the dams, average gestation duration was longer for the 125 mg/kg/day dose group than for the control and 5 mg/kg/day groups. Average gestational weight gain did not differ across treatments.
OTHER EFFECTS
Maternal Retrieval and Watermaze Navigation: No effects of sodium tungstate exposure at either dose were found in the dams for latency of maternal retrieval, or watermaze navigation latency or distance traveled.
Acoustic Startle/Prepulse Inhibition: For acoustic startle/prepulse inhibition, no significant main effects or interactions related to dose were found for any of the dependent measures.
Spontaneous Locomotor Activity: Exposure effects in the dams were detected for some of the measures of spontaneous locomotor activity. Specifically, dams treated with the low dose showed significantly more ambulatory time and distance travelled, as well as decreased time in stereotypies as compared to both controls and the high dose. In contrast, dams in the high dose demonstrated significantly less time resting, and more time in stereotypic movements than the vehicle controls or low dose group.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: no effects
Details on embryotoxic / teratogenic effects:
There were no differences in average number of pups born.
All pups were inspected for physical birth defects, including missing digits, however, none were found.
The high dose group demonstrated a greater number of ultrasonic distress vocalizations when separated from the dam and littermates.
Righting reflex: For righting reflex, a significant effect of sex was found (p <0.05) where males were faster (9.6±1.3 s) than females (14.5 ± 1.6 s). No significant effects related to dose were found.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse effects observed
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The tests were selected to provide a screening-level assessment of a range of neurobehavioral capacities in Sodium tungstate exposed dams and their offspring. The tests evaluated reflexive responding, emotionality and spatial learning and memory. Exposure-related effects were observed both in the dams and developing pups, and for low and high dose exposures. Overall, the results of this study suggest pre- and postnatal oral exposure to Sodium tungstate may produce subtle neurobehavioral effects in offspring related to motor activity and emotionality. The NOAEL for developmental toxicity was deemed to be 125 mg/kg bw/day.
- Executive summary:
In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Study Sodium tungstate was administered to 40 SD rats/sex/dose by gavage at dose levels of 0, 5, and 125 mg/kg bw/day through mating, gestation, and weaning (PND 0-20). A statistically significant difference was found for one of the treatment groups on measures of reproductive toxicity. In the dams, average gestation duration was longer for the 125 mg/kg/day dose group than for the control and 5 mg/kg/day groups. Average gestational weight gain did not differ across treatments. In the pups, there were no differences in average number of pups born.
The NOAEL for the F1 generation was 125 mg/kg/day based on the lack of significant effects.
The Reproduction/Developmental toxicity study in the rat is classified acceptable but does not completely satisfies the guideline requirements for a developmental toxicity study (OPPTS 870.3700; OECD 414) in rodents, as no detailed examination of soft tissue or skeleton of the fetuses were conducted.
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