Registration Dossier
Registration Dossier
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EC number: 204-024-4 | CAS number: 113-24-6
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- 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:
- Effect of pyruvate supplementation on body composition and mood
- Author:
- D. Kalman et al.
- Year:
- 1 988
- Bibliographic source:
- Nutrition. 1999 May;15(5):337-40. doi: 10.1016/s0899-9007(99)00034-9.
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Study on humans. No OECD guideline exists for this type of test.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium pyruvate
- EC Number:
- 204-024-4
- EC Name:
- Sodium pyruvate
- Cas Number:
- 113-24-6
- Molecular formula:
- C3H4O3.Na
- IUPAC Name:
- sodium 2-oxopropanoate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- other: humans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- three men, nine women
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 6 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 85.7 mg/kg bw/day
- Remarks:
- Assuming an average body weight of 70 kg the dose is equivalent to 85.7 mg/kg bw.
- Dose / conc.:
- 6 other: g/day
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 85.7 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: This dose was considered to be safe.
Results: F1 generation
Effect levels (F1)
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 85.7 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: This dose was considered to be safe.
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 85.7 mg/kg bw/day
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- For the conduction of a study in humans a dose of 6 g/day (85.7 mg/kg bw with an average bodyweight of 70 kg) was considered to be safed according to general knowledge.
Furthermore pyruvate is a metabolism output of glycolysis and thus present in the human body. No reproductive toxic effects are known.
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