Registration Dossier
Registration Dossier
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EC number: 202-601-5 | CAS number: 97-67-6
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The Metabolism of L- and DL-Malic Acids by Rats
- Author:
- Daniel, J.W.
- Year:
- 1 969
- Bibliographic source:
- Fd Cosmet. Toxicol. Vol. 7, pp. 103-106
- Reference Type:
- review article or handbook
- Title:
- Final Report on the Safety Assessment of Malic Acid and Sodium Malate
- Author:
- Fiume MZ, Bergfeld WF, Belsito DV, Klaassen CD, Schroeter AL, Shank RC, Slaga TJ, Snyder PW, and Andersen FA
- Year:
- 2 001
- Bibliographic source:
- Int J Toxicol 20 (Suppl 1): 47-55
Materials and methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- L-malic acid
- EC Number:
- 202-601-5
- EC Name:
- L-malic acid
- Cas Number:
- 97-67-6
- Molecular formula:
- C4H6O5
- IUPAC Name:
- malic acid
- Test material form:
- solid
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- U-14C-L-Malic Acid (sp. act. 61 µC/mmol)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- albino Wistar Aldarly Park SPF rats
- Sex:
- male
Administration / exposure
- Route of administration:
- other: oral or by intraperitoneal (i.p.) injection
- Vehicle:
- not specified
Doses / concentrations
- Dose / conc.:
- 2.5 mg/kg bw/day (nominal)
- No. of animals per sex per dose / concentration:
- The number of animals per group was not specified.
- Control animals:
- not specified
- Details on dosing and sampling:
- Urine, feces, and expired carbon dioxide were collected.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- excretion
- Results:
- Most of the radioactivity was excreted as carbon dioxide; after 24 h, 88.0 and 86.6% of orally and intraperitoneally administered L-Malic Acid, respectively, was found in expired air.
- Type:
- excretion
- Results:
- The amount of radioactivity recovered after oral and i.p. administration of L-Malic Acid was 3.2 and 3.1% in the urine and 1.4 and 1.4% in the feces, respectively.
- Type:
- excretion
- Results:
- After 24 h, the total amount of radioactivity recovered was 92.6 and 91.1% after oral and i.p. administration of L-Malic Acid, respectively.
Any other information on results incl. tables
L-Malic acid was rapidly and extensively metabolized when administered to rats by either the oral or the intraperitoneal route. In each case most of the radioactivity (83-92 %) was excreted within 24 hr as carbon dioxide in the expired air. Only small amounts of radioactivity were found in the urine (3-9 %) and
faeces (0.3-1.4 %).
Applicant's summary and conclusion
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