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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
The study is performed in line with OECD guideline 471 (Ames test), materials and methods are well described. A deviation from this guideline is that the test is not performed with Salmonella typhimurium strain TA 102 or E. coli strain WP uvrA or WP uvrA (pKM101) in order to detect cross-linking mutagens. Furthermore, no detailed information is available on the results.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Oxalic acid
- Analytical purity: 99.7%
- Source: Japan Food Additives Association (Tokyo)

Method

Target gene:
TA1535, TA1537, TA100, TA98, TA94, TA92
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
other: S. typhimurium TA92 and TA94
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix (prepared from the liver of Fischer rats)
Test concentrations with justification for top dose:
Six concentrations tested, with a maximum dose of 10.0 mg/plate. No further details reported.
Vehicle / solvent:
- Vehicle/solvent used: phosphate buffer
- Justification for choice of solvent/vehicle: test substance soluble in water
Controls
Negative solvent / vehicle controls:
yes
Remarks:
phosphate buffer
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
DURATION
- Preincubation period: Cells were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C
- Exposure duration: 2 days

SELECTION AGENT (mutation assays): histamine

NUMBER OF REPLICATIONS: duplicates
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 resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: S. typhimurium TA92
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: S. typhimurium TA94
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

The following table is extracted from the table in the publication (only the part concerning oxalic acid is presented):

Additive

CAS no.

Purity (%)

Max dose (mg/plate)

Solvent

Result

Oxalic acid

144-62-7

99.7

10.0

Phosphate buffer

-

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
Oxalic acid does not have mutagenic properties in the Ames test, under the current test conditions.
Executive summary:

200 food additives used in Japan, including oxalic acid, were tested for mutagenic properties in the Ames test. The strains of Salmonella typhimurium used are the following: TA 92, TA1535, TA100, TA1537, TA94, and TA98, with and without metabolic activation (S-9 prepared from rat liver). Negative results are showed with oxalic acid in all strains, with and without activation. It can be concluded that oxalic acid does not have mutagenic properties in the Ames test, under the current test conditions.