(+)-tartaric acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: No enough information for assessing the study value – can be used as weight of evidence

Data source

Reference

Reference Type:

publication

Title:

Primary mutagenicity screening of food additives currently used in Japan

Author:

Ishidate M Jr, Sofuni T, Yoshikawa K, Hayashi M, Nohmi T, Sawada M & Matsuoka A

Year:

1984

Bibliographic source:

Food Chem Toxicol. 22(8):623-36

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

No positive control

GLP compliance:

no

Type of assay:

bacterial forward mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(-)-tartaric acid

EC Number:

205-695-6

EC Name:

(-)-tartaric acid

Cas Number:

147-71-7

IUPAC Name:

tartaric acid

Details on test material:

- Name of test material (as cited in study report): D(-)-tartaric acid (althrough the CAS number provided in the litrature is 87-69-4, but as per the CAS number of D(-)-tartaric aicd is 147-71-7, we changed the number here )
- Analytical purity: 99.9%

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA92, TA1525, TA100, TA1537, TA94, TA98

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

s9, prepared from the liver of Fischer rats, contained 5 mM-glucose 6-phos-phate, 4mM-NADPH, 4mM-NADH, 33mM-KC1, 8 mM-MgCI 2, 100 mM-phosphate buffer (pH 7.4) and 3.75 ml S-9 (129 mg protein) in a total volume of 12.5 ml

Test concentrations with justification for top dose:

10 mg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: phosphate buffer

- Justification for choice of solvent/vehicle: it is soluble in water.

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

no

Positive control substance:

no

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation;

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days

SELECTION AGENT (mutation assays):

NUMBER OF REPLICATIONS: 1

Evaluation criteria:

The result was considered positive if the number of colonies found was twice the number in the control.

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA92, TA1525, TA100, TA1537, TA94, TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

not examined

Additional information on results:

no data

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 without metabolic activation
negative with metabolic activation

No significant increases in the number of revertant colonies were detected in any S. typhimurium strains at 10 mg/plate dose with and without metabolic activation.

Executive summary:

Salmonella/microsome tests (Ames tests) were carried out on D(-)-tartaric acid here. And no significant increases in the number of revertant colonies were detected in any S. typhimurium strains at 10 mg/plate dose with and without metabolic activation.