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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: gene mutation
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:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The host-mediated assay is a procedure that detects mutagenic substances after metabolic activation in intact mammal. In this assay, the mammal during treatment with a potential chemical mutagen is injected with an indicator organism in which mutation frequencies can be measured. After a sufficient time period, the organism are withdrawn from the animal and the induction of mutants is determined.
GLP compliance:
not specified
Type of assay:
other: Host-mediated assay utilizing Saccharomyces D3.

Test material

Constituent 1
Chemical structure
Reference substance name:
(+)-tartaric acid
EC Number:
201-766-0
EC Name:
(+)-tartaric acid
Cas Number:
87-69-4
Molecular formula:
C4H6O6
IUPAC Name:
tartaric acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): tartaric acid
- Physical state: fine granular
- Lot/batch No.: 71382

Method

Species / strain
Species / strain / cell type:
yeast, other: Saccharomyces D3
Additional strain / cell type characteristics:
not applicable
Remarks:
histidine auxotrophs
Metabolic activation:
with
Metabolic activation system:
host animal
Test concentrations with justification for top dose:
Acute study (single oral dose):
500 mg/kg bw
5000 mg/kg bw

Subacute study (five consecutive daily oral doses):
1450 mg/kg bw
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: physiol. saline
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Details on test system and experimental conditions:
METHOD OF APPLICATION: host animal (ICR mouse)

Results and discussion

Test results
Species / strain:
yeast, other: Saccharomyces D3
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Host-Mediated Assay is able to differentiate an action which may have been due to hosts' ability to detoxify or potentiate a suspected mutagen. In this study, tartaric acid was not active in Saccharomyces D3 at acute dose levels (up to 5000 mg/Kg bw) and at the subacute dose level (equal to 1450 mg/kg bw).
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Tartaric acid was not active under the test conditions.