Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline Study under GLP, only one experiment performed, but clearly negative result

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only one experiment performed

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid

EC Number:

942-166-5

Cas Number:

922708-02-9

Molecular formula:

not applicable

IUPAC Name:

Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Nomcort SG
- Substance type: not stated
- Physical state: not stated
- Analytical purity: not stated
- Lot/batch No.: P070214
- Expiration date of the lot/batch: not stated
- Stability under test conditions: not stated
- Storage condition of test material: room temperature

Method

Target gene:

Histidine, Trypthophan

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

rat Liver S9 mix

Test concentrations with justification for top dose:

0.05, 0.1, 0.5, 1.0, 5.0 mg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: The test item was found to be completely soluble in the vehicle.

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

methylmethanesulfonate

other: 2-Aminoanthracene, 6-Chloro-9-[3-(2-chloroethylamino)propylamino]-2-methoxyacridine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation);

DURATION
- Exposure duration / Expression time): 48 h

NUMBER OF REPLICATIONS: 3

Evaluation criteria:

according to Guideline (OECD 471)

Statistics:

calculation of Average and standard deviation, no further statistics performed

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

no further remarks

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

There was no detectable genotoxic activity or cytotoxicity for Nomcort SG under the conditions of the test.

Executive summary:

The genetic toxicity in bacteria was tested using the method by Ames laid down in OECD Guideline 471. Five strains of bacteria were tested (Salmonella typhimurium 98, 100, 1535, 1537 and Escherichia Coli WP2 uvrA) using a plate incorporation protocol. Nomcort SG was tested in the concentrations 0.05, 0.1, 0.5, 1.0 and 5.0 mg/plate with Acetone as solvent. Additionally positive and solvent control were tested. Metabolic activation was included using rat S9 -liver fraction.

All concentrations, positive and solvent control were tested in triplicate.

Solvent control and positive control were evaluated valid and within the historic data. No concentration of Nomcort SG with or without metabolic activation yielded in an increased mutagenic response, as well as no cytotoxicity was noted.

Nomcort SG was evaluated as NOT MUTAGENIC under the conditions of the test.