Registration Dossier
Registration Dossier
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EC number: 202-601-5 | CAS number: 97-67-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- 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
- Limit test:
- no
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
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Remarks:
- albino CD-1 outbred mice
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Remarks:
- 25% aq. solution
- Doses:
- 5 doses (not specified)
- No. of animals per sex per dose:
- 5
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 660 mg/kg bw
- Mortality:
- Signs of toxicity included death.
- Clinical signs:
- other: Signs of toxicity included ataxIa, prostration and convulsions.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
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