Registration Dossier
Registration Dossier
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EC number: 230-022-8 | CAS number: 6915-15-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Experimental data reporetd in peer reviewed journal
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- Study date preceeds implementation of GLP regulations
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Malic acid
- EC Number:
- 230-022-8
- EC Name:
- Malic acid
- Cas Number:
- 6915-15-7
- Molecular formula:
- C4H6O5
- IUPAC Name:
- 2-hydroxybutanedioic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): No data
MAXIMUM DOSE VOLUME APPLIED: No data - Doses:
- No data
- No. of animals per sex per dose:
- 5 male / 5 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No data
- Clinical signs:
- other: Ataxia, prostration, convulsions and death
- Gross pathology:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 in the rat is reported to be 3500 mg/kg body weight
- Executive summary:
The acute oral LD50 in the rat is reported to be 3500 mg/kg body weight
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