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Toxicological information

Basic toxicokinetics

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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:
1949
Bibliographic source:
J. Biol. Chem. 180, 1187-1195
Reference Type:
publication
Title:
SIDS Initial Assessment Report For SIAM 22
Author:
OECD
Year:
2006
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:
1987
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:
1978
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
Name:
Unnamed
Type:
Constituent
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:
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