Registration Dossier
Registration Dossier
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EC number: 213-911-5 | CAS number: 1066-33-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles; data taken from EU risk assessment/SIDS
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Studies on the hazard involved in the use of 14C. Retention of carbon from labeled sodium bicarbonate
- Author:
- Skipper HE, White L and Bryan CE
- Year:
- 1 949
- Bibliographic source:
- J. Biol. Chem. 180, 1187-1195
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report For SIAM 22
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- OECD SIDS AMMONIUM BICARBONATE
- Reference Type:
- secondary source
- Title:
- Final Report on the Safety Assessment of Sodium Sesquicarbonate, Sodium Bicarbonate, and Sodium Carbonate
- Author:
- Johnson W and Swanson K
- Year:
- 1 987
- Bibliographic source:
- Journal of the American College of Toxicology, 6(1), 121-138
- Reference Type:
- publication
- Title:
- Sodium bicarbonate
- Author:
- US Food and Drug Administration (FDA)
- Year:
- 1 978
- Bibliographic source:
- Federal Register, vol. 43, no. 114, p52440-52443
Materials and methods
- Objective of study:
- excretion
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
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
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C-sodium bicarbonate
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- single application
Doses / concentrations
- Remarks:
- Doses / Concentrations:
18 µCi
- No. of animals per sex per dose / concentration:
- no data
- Control animals:
- not specified
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY
- Tissues and body fluids sampled: blood and various organs of the body
- Time and frequency of sampling: after 24 and 48h and 1, 2, 4 and 12 weeks
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- After 1 h, more than 90 % of the total radioactivity injected was lost through the lungs.
Most of the radioactivity in the blood was in non-carbonate form after 24 h.
Applicant's summary and conclusion
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