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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:
1988
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

Constituent 1
Chemical structure
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

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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