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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Bacterial mutagenicity testing of 49 food ingredients gives very few positive results
Author:
Michael J. Prival, Vincent F. Simmon, and Kristien E. Mortelmans
Year:
1991
Bibliographic source:
Mutation Research, 260 (1991) 321-329

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Gene mutation toxicity study was performed to determine the mutagenic nature of Ascorbyl palmitate
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Ascorbyl palmitate
- Molecular formula: C22H38O7
- Molecular weight: 414.5352 g/mol
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material: Ascorbyl palmitate
- Molecular formula: C22H38O7
- Molecular weight: 414.5352 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:
Histidine
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2
Details on mammalian cell type (if applicable):
Not appliicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
10% Aroclor 1254-induced liver S9 from male Sprague-Dawley rats.
Test concentrations with justification for top dose:
0, 0.010 – 3.3 mg per plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was soluble in DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: furylfuramide or N-methyl-N'-nitro-N-nitrosoguanidine (E. coli WP2;without S9) and Anthramine (All strains; with S9)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: All platings were performed in duplicate and all tests were
repeated.

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data
Rationale for test conditions:
No data
Evaluation criteria:
Test results were considered valid only if the positive control compounds induced increases in mutant counts to at least twice background.
Statistics:
No data

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data

Applicant's summary and conclusion

Conclusions:
Ascorbyl palmitate did not induce mutation in the Salmonella typhimurium strain TA98, TA100, TA1535, TA1537 and TA1538 and Escherichia coli strain WP2 with and without rat liver S9 mix and hence the chemical is negative for gene mutation in vitro.
Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of Ascorbyl palmitate. The study was performed as per the plate incorporation protocol and the test chemical dissolved inDMSO was used at dose levels of0, 0.010 – 3.3 mg per plate. Concurrent solvent and positive controls were run with the test chemical. Test results were considered valid only if the positive control compounds induced increases in mutant counts to at least twice background. Ascorbyl palmitatedid not induce mutation in theSalmonella typhimurium strain TA98, TA100, TA1535, TA1537 and TA1538 and Escherichia coli strain WP2 with and without rat liver S9 mix and hence the chemical is negative for gene mutation in vitro.