Registration Dossier
Registration Dossier
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EC number: 213-067-8 | CAS number: 921-53-9
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- other: Data sharing dispute.
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been assessed for the use in a category approach. According to the met hodology and to the extent of available details, the study has been judged as reliable with restrictions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Metabolism of L(+)- and D(-)-Tartaric Acids in Different Animal Species
- Author:
- J. Gry and J.c. Larsen
- Year:
- 1 978
- Bibliographic source:
- Toxicological Aspects of Food Safety Arch. Toxicol., Suppl. l, 351-353
Materials and methods
- Objective of study:
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Version / remarks:
- the study was performed prior to the adoption of the test guideline specified
- Deviations:
- yes
- Remarks:
- An in vitro incubation was used in the study: The acids were incubated at 37 ℃ with caecal extracts in a medium consisting of glucose, yeast extract, and 0.1 M phosphate buffer pH7.0 under anaerobic conditions
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (+)-tartaric acid
- EC Number:
- 201-766-0
- EC Name:
- (+)-tartaric acid
- Cas Number:
- 87-69-4
- Molecular formula:
- C4H6O6
- IUPAC Name:
- (2R,3R)-2,3-dihydroxybutanedioic acid
- Test material form:
- not specified
- Details on test material:
- no data.
Constituent 1
- Radiolabelling:
- not specified
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals had no access to food 16 h prior to the experiments.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg
- No. of animals per sex per dose / concentration:
- 5 F and 5 M in 1000 mg/kg L (+) - tartaric acid rat group
- Control animals:
- not specified
Results and discussion
- Preliminary studies:
- The preliminary study reports the in vivo and in vitro experimental result as well.
Main ADME results
- Type:
- excretion
- Results:
- % of dose recovered in urine after 48 h: 72.9±15.7
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- % of dose recovered in urine after 48 h: 72.9±15.7
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
In this study, the metabolic fate of L (+) - tartaric acids is observed in rats. No effects on toxicity were detected in rats. - Executive summary:
In this study, the metabolic fate of L (+) - tartaric acids is observed in rats. No effects on toxicity were
detected in rats.
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