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EC number: 205-613-9 | CAS number: 144-02-5
- 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
- Study period:
- 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- THE TERATOGENICITY OF BARBITAL SODIUM IN MICE
- Author:
- PERSAUD TN and HENDERSON WM
- Year:
- 1 969
- Bibliographic source:
- ARZNEIM FORSCH 19:1309-1310,1969
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Sodium barbital was administered daily i.p. in three dose groups on days one to six of gestation to twenty pregnant albino mice of the Rockefeller strain. Foetuses recovered from pregnancies terminated on the eighteenth day were examined for external and internal gross malformations. The incidence of resorption and foetal death were evaluated. In some cases the skeletal development of the foetus was determined by staining with alizarin red.
- GLP compliance:
- no
- Remarks:
- before GLP
Test material
- Reference substance name:
- Barbital sodium
- EC Number:
- 205-613-9
- EC Name:
- Barbital sodium
- Cas Number:
- 144-02-5
- Molecular formula:
- C8H11N2O3.Na
- IUPAC Name:
- sodium 5,5-diethyl-4,6-dioxo-1,4,5,6-tetrahydropyrimidin-2-olate
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- sodium 5,5-diethylbarbiturate
Test animals
- Species:
- mouse
- Strain:
- other: Rockefeller strain
- Details on test animals or test system and environmental conditions:
- Maintained on standard Purina lab chow and water ad libitum, were housed in individual cages.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- other: physiological saline
- Details on exposure:
- Since the dose of 65 mg/kg body weight i.p. did not produce much evidence of teratogenicity it was increased to 115 and 330 mg/kg body weight respectively. Animals of the control group received daily 0.1 ml physiological saline i.p. from days one to six of gestation. Animals of the control group received daily 0.1 ml physiological saline i.p. from days one to six of gestation.
- Details on mating procedure:
- No details given on mating procedure.
Conception was marked by the appearance of a vaginal mating plug and considered to be day 0. - Duration of treatment / exposure:
- From days one to six of gestation.
- Frequency of treatment:
- daily
- Duration of test:
- Study was terminated on the eighteenth day.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 65 mg/kg bw/day
- Dose / conc.:
- 115 mg/kg bw/day
- Dose / conc.:
- 330 mg/kg bw/day
- No. of animals per sex per dose:
- 65 mg/kg bw: 4 females
115 mg/kg bw: 8 females
330 mg/kg bw: 8 females
control: 11 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sodium barbital (sodium 5,5-diethylbarbiturate) dissolved in physiological saline, 0.05-0.1 ml pH 9.6, was administered daily i.p. on days one to six of gestation to twenty pregnant albino mice of the Rockefeller strain. Conception was marked by the appearance of a vaginal mating plug and considered to be day 0, Since the dose of 65 mg/kg body weight i.p. did not produce much evidence of teratogenicity it was increased to 115 and 330 mg/kg body weight respectively. Animals of the control group received daily 0.1 ml physiological saline i.p. from days one to six of gestation. The pregnant animals, maintained on standard Purina lab chow and water ad libitum, were housed in individual cages. Foetuses recovered from pregnancies terminated on the eighteenth day were examined for external and internal gross malformations. The incidence of resorption and foetal death were evaluated. In some cases the skeletal development of the foetus was determined by staining with alizarin red.
Examinations
- Maternal examinations:
- One animal in the experimental group 330 mg/kg bw and one animal in the experimental group 115 mg/kg bw died during treatment.
- Fetal examinations:
- Of the 102 foetuses recovered from treated mothers 61 (59.8%) had malformations. No skeletal abnormalities were observed.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- One animal in the experimental group 330 mg/kg bw and one animal in the experimental group 115 mg/kg bw died during treatment.
- Body weight and weight changes:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- Death of the conceptus followed by resorption was noted in significant numbers when sodium barbital was given.
65 mg/kg bw: 11.8% (4 resorption sites, 34 implantation sites)
115 mg/kg bw: 26.2% (16 resorption sites, 61 implantation sites)
330 mg/kg bw: 46.0% (23 resorption sites, 46 implantation sites)
control: 1.1% (1 resorption site, 93 implantation sites)
Effect levels (maternal animals)
- Dose descriptor:
- LOEL
- Effect level:
- 65 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- total litter losses by resorption
Results (fetuses)
- External malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Of the 102 foetuses recovered from treated mothers 61 (59.8%) had malformations.
65 mg/kg bw: 26.7% malformed fetuses (8 malformed fetuses, 22 normal fetuses)
115 mg/kg bw: 71.1% malformed fetuses (32 malformed fetuses, 13 normal fetuses)
330 mg/kg bw: 77.8% malformed fetuses (21 malformed fetuses, 6 normal fetuses)
control: 4.3% malformed fetuses (4 malformed fetuses/stunting, 88 normal fetuses) - Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- No skeletal abnormalities were observed.
- Visceral malformations:
- not examined
Effect levels (fetuses)
- Dose descriptor:
- LOAEL
- Effect level:
- 65 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- external malformations
Fetal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- external: limb
- external: umbilicus
- other: Hydrocephalus, Stunting
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 65 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects occurring together with maternal toxicity effects, but not as a secondary non-specific consequence of maternal toxicity effects
Applicant's summary and conclusion
- Conclusions:
- The teratogenic activity of sodium barbital in pregnant mice of the Rockefeller strain was investigated. A high incidence of foetal resorption and congenital malformations were observed following the i.p. administration of 65/115/330 mg/kg bw of the barbiturate.
- Executive summary:
Sodium barbital (sodium 5,5-diethylbarbiturate) dissolved in physiological saline, 0.05-0.1 ml pH 9.6, was administered daily i.p. on days one to six of gestation to twenty pregnant albino mice of the Rockefeller strain. Conception was marked by the appearance of a vaginal mating plug and considered to be day 0. Since the dose of 65 mg/kg body weight i.p. did not produce much evidence of teratogenicity it was increased to 115 and 330 mg/kg body weight respectively. Animals of the control group received daily 0.1 ml physiological saline i.p. from days one to six of gestation. The pregnant animals, maintained on standard Purina lab chow and water ad libitum, were housed in individual cages. Foetuses recovered from pregnancies terminated on the eighteenth day were examined for external and internal gross malformations. The incidence of resorption and foetal death were evaluated. In some cases the skeletal development of the foetus was determined by staining with alizarin red.
One animal in the experimental groups 330 mg/kg bw and 115 mg/kg bw died during treatment. Death of the conceptus followed by resorption was noted in significant numbers when sodium barbital was given (65-330 mg/kg) during the first six days of gestation. As determined from total resorption sites 30.1% of the embryos were killed following treatment. Foetal mortality in the control group was 1.1% of all implantations. Of the 102 foetuses recovered from treated mothers 61 (59.8%) had malformations. No skeletal abnormalities were observed in the few specimens cleared and stained with alizarin red.
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