Registration Dossier
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EC number: 231-135-5 | CAS number: 7440-25-7
- 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:
- supporting study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study data from literature relating to non-standard test methods. The experiment was conducted in accordance with accepted scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Fetal Development Effects
- Author:
- Benson KA
- Year:
- 1 998
- Bibliographic source:
- AFRRI Special Publication 98(3): 17-21
- Reference Type:
- publication
- Title:
- Health Effects of Depleted Uranium Fragments
- Author:
- Armed Forces Radiobiology Research Institute
- Year:
- 1 998
- Bibliographic source:
- Livengood DR (ed) An Armed Forces Radiobiology Research Institute Workshop
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A study was conducted to investigate the transfer of depleted uranium from mother to foetus to gain an understanding of the degree of foetal exposure and developmental effects from maternally implanted uranium. Tantalum was used in the study as a chemically inert control.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Tantalum
- EC Number:
- 231-135-5
- EC Name:
- Tantalum
- Cas Number:
- 7440-25-7
- Molecular formula:
- Ta
- IUPAC Name:
- tantalum
- Test material form:
- solid: pellets
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: (P) Females: 250 - 300 g
- Housing: Two females were housed with one untreated male during the breeding phase. From Gestation day 0 until gestation day 20 females were housed individually.
Administration / exposure
- Route of administration:
- implantation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- 16 female rats were surgically implanted with 12 tantalum pellets, a non-surgical control was included.
- Details on mating procedure:
- - M/F ratio per cage: 1:2.
- Proof of pregnancy: Gestational Day (GD) 0 was determined by the presence of sperm in the vaginal washing.
- After successful mating each pregnant female was caged (how): individually. - Duration of treatment / exposure:
- Animals were bred 7 - 14 days post-implantation; dams were euthanised on GD 20.
- Frequency of treatment:
- The test material was implanted during one surgical procedure. The implant remained in place until the animals were euthanised.
- No. of animals per sex per dose:
- 16
- Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- Pregnant rats were monitored daily for weight gain, food intake and water intake.
- Ovaries and uterine content:
- Following euthanisation, dams were immediately subjected to caesarean-section and the uterine horns removed.
The uterine horns were examined for any resorption sites. - Fetal examinations:
- Following euthanisation of the dams, foetuses were dissected out and all the placentae for that litter were collected. Litters were examined and a record made of:
-the total number of foetuses
-the number of viable foetuses
-the sex ratio
-any overt signs of teratological effects
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The maternal results are summarised in Table 1.
There was no effect on maternal food and water intake, weight gain during pregnancy and time-to-pregnancy.
Implanted pellets did not affect the ability of the rats breed or maintain the pregnancy until the day of euthanasia.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The litter data are summarised in Table 2
No effects were seen on the following litter parameters:
-the number of pups
-the number of males vs. females
-foetal weights
All litters were examined for overt signs of teratology and none were noted.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1 Effects of Implanted Tantalum on Maternal Parameters
Variable | No Surgery | 12 Implanted Ta Pellets |
# Dams bred | 16 | 16 |
Days to pregnancy (SEM) | 3.9 (± 1.76) | 2.08 (± 0.23) |
Mean weight gain (g) | 133.79 (± 8.13) | 138.32 (± 6.49) |
Mean food intake (g) | 23.44 (± 0.67) | 24.51 (± 0.68) |
Mean water intake (mL) | 43.85 (± 2.59) | 44.45 (± 2.60) |
Table 2 Effects of Tantalum on Litter Data
Variable | No Surgery | 12 Implanted Ta Pellets |
Total # foetuses | 13.8 (± 0.79) | 13..5 (± 0.78) |
# Males | 6.6 | 6.3 |
# Females | 7.2 | 7.2 |
# Non-viable | 0 | 1 |
Average pup weight | 3.56 (± 0.20) | 3.164 (± 0.09) |
Applicant's summary and conclusion
- Conclusions:
- The maternally implanted tantalum pellets had no developmental effects on offspring.
- Executive summary:
A study was conducted to investigate the transfer of depleted uranium from mother to foetus to gain an understanding of the degree of foetal exposure from maternally implanted uranium. The impact of the depleted uranium on the dam’s ability to become pregnant and carry her litter to term was also investigated. Tantalum was used in the study as a chemically inert control.
Pregnant rats were monitored daily for weight gain, food intake and water intake. Following euthanisation, dams were immediately subjected to caesarean-section. The uterine horns were removed and foetuses were dissected out.
Litters were examined and a record made of the total number of foetuses, the number of viable foetuses, the sex ratio and any overt signs of teratological effects.
No effects were seen on the litters relating to the number of pups, the number of males vs. females and foetal weights. All litters were examined for overt signs of teratology and none were noted.
There were no effects reported in this study relating to maternal implantation of the test material.
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