Oleic acid, monoester with propane-1,2-diol

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

2-(3,4-dihydroxy-5-oxo-2,5-dihydrofuran-2-yl)-2-hydroxyethyl palmitate

Cas Number:

137-66-6

Molecular formula:

C22H38O7

IUPAC Name:

2-(3,4-dihydroxy-5-oxo-2,5-dihydrofuran-2-yl)-2-hydroxyethyl palmitate

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 / strain

Species / strain 1

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 2

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 results

Test results 1

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

Test results 2

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.