N6-(1-oxododecyl)-L-lysine

Genetic toxicity: in vitro

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

2010

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N6-(1-oxododecyl)-L-lysine

EC Number:

257-843-4

EC Name:

N6-(1-oxododecyl)-L-lysine

Cas Number:

52315-75-0

Molecular formula:

C18H36N2O3

IUPAC Name:

N6-(1-oxododecyl)-L-lysine

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Name: Nε-Lauroyl-L-Lysine
Supplier: Ajinomoto Co., Inc.
Molecular weight: 328.50
Lemon yellow powder with a purity of 95%

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0, 5, 10, 50, 100, 500, 1000 and 5000 ug/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

N-ethyl-N-nitro-N-nitrosoguanidine

furylfuramide

other: 2-aminoanthracene

Details on test system and experimental conditions:

The test was performed using the pre-incubation method with and without metabolic activation.

Evaluation criteria:

The results are judged as positive for inducibility of gene mutation when the number of revertant colonies per plate (mean) increases dose-dependently 2-fold or greater compared with that in the negative control. It is judged that the study has been performed satisfactorily when the number of revertant colonies in the negative and positive controls is within the range.

Statistics:

not further specified

Results and discussion

Test results

Key result

Species / strain:

other: S. typhimurium TA98, TA100, TA1535, TA1537, TA1538 and Escherichia coli WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test item did not induce gene mutationn in bacteria.

Executive summary:

The test item was tested in a study comparable to OECD Guideline 471 with Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 as well as with Escherichia coli WP2uvrA using the pre-incubation method with and without metabolic activation. The test was performed with levels of 0 – 5000 ug/plate. A growth inhibition was observed at 5000 ug/plate in TA1535, TA98 and TA1537 without metabolic activation. A precipitation was not observed up to 5000 ug/plate both with and without metabolic activation.

Therefore, the test item did not induce gene mutations in bacteria.