Registration Dossier
Registration Dossier
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EC number: 204-024-4 | CAS number: 113-24-6
Endpoint summary
Administrative data
Description of key information
One repeated-dose key study, oral route on humans is available. This study is well documented and reliable and thus the basic for the DNEL calculation.
One repeated-dose supporting study, inhalative route is available which mainly focussed on another test substance. Thus this study is not considered for the DNEL calculation.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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
- 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
- Species:
- other: human
- Sex:
- male/female
- 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
- 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
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- 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
- 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
- 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. - Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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
- Justification for type of information:
- Both calcium pyruvate and sodium pyruvate dissociate rapidly into pyruvate anions and the metal cations. Calcium and sodium are present in the organism in high concentrations and known to be non-toxic in the tested concentrations. Thus a toxic effect would be caused by the pyruvate and a read-across approach between calcium pyruvate and sodium pyruvate is reasonable.
- Reason / purpose for cross-reference:
- read-across source
- 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
- Species:
- other: human
- Sex:
- male/female
- 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
- 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
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 188.75 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: sodium pyruvate
- 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
- 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
- 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.
The following molecular weight correction has to be applied:
molecular weight calcium pyruvate: 214.19 g/mol
molecular weight sodium pyruvate: 110.04 g/mol
NOEL (calcium pyruvate) 367.4 mg/kg bw / 214.19 g/mol * 110.04 g/mol = 188.75 mg kg bw (sodium pyruvate)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- Species:
- other: human
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
