Registration Dossier
Registration Dossier
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EC number: 205-633-8 | CAS number: 144-55-8
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Taken from OECD SIDS on Sodium bicarbonate (2002), where a similar reliability was assigned. Unsuitable test system, as the solution was administered intravenously. Insufficient documentation for assessment, as the study was carried out to assess the correlation between hyperosmolality and brain damage. NaHCO3 was used as a hypertonic solution.
Data source
Reference
- Reference Type:
- publication
- Title:
- Intracranial hemorrhage following administration of sodium bicarbonate in rabbits
- Author:
- Sugimoto, T. et al.
- Year:
- 1 981
- Bibliographic source:
- Brain and Development, vol. 3, no. 3:297-303
Materials and methods
- Principles of method if other than guideline:
- other
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium hydrogencarbonate
- EC Number:
- 205-633-8
- EC Name:
- Sodium hydrogencarbonate
- Cas Number:
- 144-55-8
- Molecular formula:
- CH2O3.Na
- IUPAC Name:
- sodium hydrogen carbonate
- Details on test material:
- SOURCE: Not reported.
PURITY: Not reported.
IMPURITY/ADDITIVE/ETC.:Not reported.
ANY OTHER INFORMATION: Not reported.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- - Source: Not reported.
- Age: Not reported.
- Weight at study initiation: 1-1.5 kg
- Controls: In group 3 the animals were in a hypoxic environment for 3 hrs.
Administration / exposure
- Route of administration:
- infusion
- Vehicle:
- not specified
- Doses:
- 7% NaHCO3 (group 1), 7% NaHCO3 + 10% hypoxia (group 2), 10% hypoxia (group 3)
- No. of animals per sex per dose:
- 27
Results and discussion
Any other information on results incl. tables
MORTALITY:
- Time of death: Within two hours.
- Number of deaths at each dose: The drip continued until death due to hyperosmolality, within two hours, in group 1 and 2. 4 of 5 survived in group 3.
CLINICAL SIGNS: Not reported.
NECROPSY FINDINGS:
All the young rabbits exposed to 7% NaHCO3 died with hyperosmolality at over 380 mOsm/L (the mean was 462 mOsm/L)
after the drip infusion. The mean for group 2 was 393 mOsm/l and for group 3, 300 mOsm/l. pH rose with the start of drip infusion and showed strong alkalosis. Fatal intracranial hemorrhage was induced by hyperosmolality and was enhanced by the combination of hypoxia and immaturity.
POTENTIAL TARGET ORGANS: Only the brain was examined.
SEX-SPECIFIC DIFFERENCES: Not reported.
Applicant's summary and conclusion
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