Registration Dossier
Registration Dossier
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EC number: 204-024-4 | CAS number: 113-24-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- For studies in humans no OECD guideline exist.
The study is well documentated including experimental details. - GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Calcium pyruvate
- EC Number:
- 257-599-9
- EC Name:
- Calcium pyruvate
- Cas Number:
- 52009-14-0
- Molecular formula:
- C3H4O3.1/2Ca
- IUPAC Name:
- calcium bis(2-oxopropanoate)
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- other: human
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: capsule
- Details on route of administration:
- Nine recreationally active subjects (8 women, 1 man; 64.9 +- 3.1 kg) consumed 7, 15, and 25 g of pyruvate.
- Vehicle:
- water
- Details on analytical verification of doses or concentrations:
- After consumation of the pyruvate blood samples were collected every 30 minutes for a 4-h period. Urine was collected throughout the duration of the 4-h period for analysis of the pyruvate content.
- Duration of treatment / exposure:
- daily, 7 d
Doses / concentrationsopen allclose all
- Dose / conc.:
- 25 other: g calcium pyruvate
- Dose / conc.:
- 15 other: g calcium pyruvate
- Dose / conc.:
- 7 other: g calcium pyruvate
- No. of animals per sex per dose:
- 8 women, 1 man
Results and discussion
Results of examinations
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 367.4 mg/kg bw/day (actual dose received)
- Based on:
- test mat. (total fraction)
- Sex:
- male/female
- Basis for effect level:
- haematology
- urinalysis
- Remarks on result:
- other: calcium pyruvate
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 25 other: g calcium pyruvate
- Based on:
- test mat. (total fraction)
- Sex:
- male/female
- Basis for effect level:
- haematology
- urinalysis
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 25 other: g calcium pyruvate
- System:
- other: no effect was observed in any system
- Organ:
- other: no effect was observed in any organ
Applicant's summary and conclusion
- Conclusions:
- Up to an daily uptake of 25 g calcium pyruvate for 7 days no adverse effects were observed.
Based on a body weight of maximum 68 kg this corresponds to 367.4 mg/kg bw.
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