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Toxicological information

Genetic toxicity: in vitro

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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:
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:
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.