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EC number: 233-786-0 | CAS number: 10361-29-2
- 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
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment. Very few of the parameters measured in a guideline test were monitored in this study. The volume injected and vehicle is unknown. Only two animals were used in each exposure group.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
- Principles of method if other than guideline:
- Four drugs— trypan blue, urethane, cyclophosphamide and methotrexate- were administered i.p. into pregnant mice on the 7th to 9th day of gestation.
- GLP compliance:
- no
- Remarks:
- (the study as executed before the existence of GLP)
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium hydrogencarbonate
- EC Number:
- 205-633-8
- EC Name:
- Sodium hydrogencarbonate
- Cas Number:
- 144-55-8
- IUPAC Name:
- sodium hydrogen carbonate
- Test material form:
- other: liquid
- Details on test material:
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Details on test animals or test system and environmental conditions:
- Species: Mouse: swizz albino
Source: no data
Number per sex: 127 females, 12 males
Stage of pregnancy at test initiation: 7 weeks
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- not specified
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 2 %. - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- The breeding groups consisted of six females and two males in each cage, females were examined in the morning and afternoon for evidence of mating. Females with fresh vaginal plugs were isolated and the date noted as the first day of pregnancy.
- Duration of treatment / exposure:
- The mice were exposed i.p. on day 7, 8 and 9 of pregnancy, and sacrificed on day 14 of the pregnancy.
- Frequency of treatment:
- Daily
- Duration of test:
- 7 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2% NaHCO3
Basis:
nominal conc.
- Control animals:
- yes
- Details on study design:
- In this study the NaHCO3 group of animals was considered a control group together with a group receiving saline and an untreated group.
Examinations
- Maternal examinations:
- - Histopathology P: Animals (P) were killed on the fourteenth day of pregnancy, and the uteri removed. The uterus was examined for implantation sites, viable fetuses and resorption sites.
- Fetal examinations:
- Viable foetuses (F1) were examined for grossly visible malformations. Histological preparations were made of selected foetuses.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
- Gross pathology incidence and severity: There were 2 resorption sites in total in the two females, compared to 2 resorption sites in 3 saline treated controls.
- Number of implantations: 22
- Litter size and weights: There were 20 viable foetuses in total from two females. In the control groups 27 foetuses were counted in 3 saline treated females, and 17 foetuses in 2 untreated females.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
In the NaHCO3 group, hematomas were found in 4 foetuses (of a total of 20); no other abnormalities were found. The increased incidence of hematomas may be incidental, as in the groups tested with a drug (the only which 2% NaHCO3 was added to), hematomas were also observed. No abnormalities were observed in the other control groups.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Observations of control females:
Except for hematoma formation observed in four fetuses from females injected with 2% NaHCO3 solution, no gross abnormalities were detected among the fetuses.
Frequency of embryo lethality and gross abnormalities:
More resorption sites were observed among the experimental groups than the 6% in the control group. Successful implantations and viable fetuses were greatly reduced with methotrexate (28%), cyclophosphamide (58%), and trypan blue (62%) treatments and to a lesser extent with urethane (74%). Gross externally visible defects were generally not observed except in the case of cyclophosphamide, where microencephaly (abnormally small cerebral hemispheres) occurred in 3 of 21 viable fetuses. Multiple hematomas were found on 5 of 8 fetuses of the methotrexate group and 4 of 20 fetuses in the NaHCO3-treated controls.
Microscopic examination of the fetuses:
Three fetuses from the methotrexate group were indistinguishable from the controls. The three microencephalic fetuses of the cyclophosphamide group were retarded in neural development but appeared otherwise to be histologically well differentiated. Four of five fetuses in the trypan blue group and one of the two fetuses of the urethane group, despite their superficially normal appearance, revealed obvious internal degenerative changes when examined microscopically. In the trypan blue group the basic neural organization was maintained but the tissues were clearly undergoing degenerative changes. The damage was more extensive in the brain region than posteriorly. The surrounding tissues and especially the mesenchyme were sparse. One fetus in the urethane group was normal and the other obviously morbid. In the latter the mesenchyme was overabundant and the cells were atypically rounded and clumped. The cells of the neural epithelium were few in number and loosely and abnormally arranged. The neural epithelium was generally thin, often discontinuous, and thrown into numerous irregular folds.
Applicant's summary and conclusion
- Conclusions:
- The four drugs were found to be detrimental to the embryos when administered to pregnant females during the sensitive period in the morphogenesisof the nervous system.
- Executive summary:
Four drugs— trypan blue, urethane, cyclophosphamide and methotrexate— were tested to ascertain their deleterious effects on the
neural development of the mouse embryo. The drugs were administered i.p. into pregnant females on the 7th to 9th day of gestation. The
animals were sacrificed on the 14th day and gross and microscopic examinations of the uterine contents were made. From counts of viable fetuses and resorption sites all four drugs appeared to increase fetal mortality, methotrexate the most, and urethane the least. Within the range of the drug dosage tested only cyclophosphamide treatment resulted in grossly visible neural defects; however, microscopic examination of representative fetuses in the trypan blue and urethane treatment groups revealed histologically obvious degenerative alterations. Methotrexate-treated fetuses appeared to be unaffected.
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