Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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.

Data source

Reference
Reference Type:
publication
Title:
Primary mutagenicity screening of food additives currently used in Japan
Author:
Ishidate Jr., M., Sofuni, T., Yoshikawa, K., Hayashi, M., Nohmi, T., Sawada, M., Matsuoka, A.
Year:
1984
Bibliographic source:
Food Chemistry and Toxicology, Vol. 22, No. 8, p 623-636

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
6 different strains of Salmonella typhimurium were used, but one of the recommended strain TA102 (or an E.coli strain) was not included.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Oxalic acid
EC Number:
205-634-3
EC Name:
Oxalic acid
Cas Number:
144-62-7
IUPAC Name:
oxalic acid
Details on test material:
- 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
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium, other: TA92 and TA94
Details on mammalian cell type (if applicable):
Not applicable
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(s)/solvent(s) 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, TA 1537, TA 98 and 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:
S. typhimurium, other: TA92 and TA94
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
not specified
Additional information on results:
No data
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

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

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 (migrated information):
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, among which oxalic acid, were tested for mutagenic properties in the Ames test. Six strains of Salmonella typhimurium were tested: TA1535, TA1537, TA98, TA100, TA92 and TA94, with and without metabolic activation (S-9 from rat liver). Oxalic acid tested negative 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.

Categories Display