L-Alanine, N-coco acyl derivs., sodium salts

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:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1997

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

L-Alanine, N-coco acyl derivs., sodium salts

EC Number:

290-478-9

EC Name:

L-Alanine, N-coco acyl derivs., sodium salts

Cas Number:

90170-45-9

Molecular formula:

RHNNaO3

IUPAC Name:

L-Alanine, N-coco acyl derivs., sodium salts

Test material form:

solid

Specific details on test material used for the study:

Name: (S)-Sodium 2-cocoylamino-propionate
BML-CODE: BML-8156
Lot No.: 050126BP
Purity: 30%
Concentration of impurities: 70% (water)
Appearance at room temperature: clear liquid

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9 mix

Test concentrations with justification for top dose:

Without S9 mix: 2.4, 4.9, 10, 20, 39, 78, 156 and 313 μg/plate
With S9 mix: 10, 20, 39, 78, 156, 313, 625, 1250, 2500 and 5000 μg/plate

Vehicle / solvent:

water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

benzo(a)pyrene

other: 2-aminoanthracene (with S9 mix); 2-(2-Furyl)-3-(5-mtro-2-furyl)acrylamide (without S9 mix)

Details on test system and experimental conditions:

The dose range for the main test was determined from the preliminary test using the following seven dose levels: 1.2, 4.9, 20, 78, 313, 1250 and 5000 μg/plate.

Evaluation criteria:

In the main tests carried out twice, if the number of revertant colonies on the test plates increased significantly in comparison with that on the control plates (based on twice as many as that of the negative control), and a dose-response and reproducibility were also observed, the test substance was to be judged positive. The results at each concentration were demonstrated with the mean and the standard deviation.

Statistics:

Standard statistical methods were used

Results and discussion

Test results

Key result

Species / strain:

other: all strains tested

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test item was tested negative in a bacterial reverse mutation assay performed according to OECD GL 471 with GLP compliance when testet in Salmonella typhimurium TA 100, TA 1535, TA 98, TA1537 and Escherichia coli WP2 uvrA.

Executive summary:

The mutagenic potential of Sodium N-Cocoyl-L-Alaninate was assessed with Salmonella typhimurium TA 100, TA 1535, TA 98, TA1537 and Escherichia coli WP2 uvrA. In this study, neither an increase in the number of revertant colonies more than twice in comparison with that of the negative control nor a dose-related response was observed in any strains of base-pair substitution type or frame-shift type, with or without metabolic activation. Therefore, Sodium N-Cocoyl-L-Alaninate solution has no mutagenicity forward to bacteria under the described study conditions.