Registration Dossier

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
weight of evidence
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 methodology 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:
1978
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:
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Radiolabelling:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
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 excretion:
% 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.