Glycine, 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:

1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Glycine, N-coco acyl derivs., sodium salts

EC Number:

291-350-5

EC Name:

Glycine, N-coco acyl derivs., sodium salts

Cas Number:

90387-74-9

Molecular formula:

Molecular formula for this UVCB is not available.

IUPAC Name:

Glycine, N-coco acyl derivs., sodium salts

Specific details on test material used for the study:

Name (alias name): Sodium Cocoyl aminoacetate (Sodium cocoyl glycinate)
BML registration number: BML-3635
Lot No.: 970925
Purity: 28 wt%
Name of impurity and its concentration: Sodium cocoate (3 wt%)
Appearance at room temperature: Clear liquid
Stability: Three months at room temperature
Solubility: Water (30% or more)
Stability in a solvent: Three months in water, in a dark place at room temperature.
Storage: Refrigerated, shielded conditions

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:

S9 mix

Test concentrations with justification for top dose:

Seven concentrations (1.2, 4.9, 20, 78, 313, 1250 and 5000 ug/plate) were tested in order to determine the concentrations of the test article for use in the main test. In the preliminary test, without metabolic activation, the growth of the S. typhimurium TA strains was inhibited at a concentration of >= 78 ug/plate and the growth of E. coli WP2 uvrA was inhibited at 5000 ug/plate. With metabolic activation, the growth of the S. typhimurium TA strains was inhibited at a concentration of >= 313 ug/plate and the growth of E. coli WP2 uvrA was inhibited at 5000 ug/plate. No precipitation was observed on any plate in either test system.
From these results, the highest concentration of the test article for S. typhimurium TA strains was set at 78 ug/plate without metabolic activation and 313 ug/plate with metabolic activation. The highest concentration of the test article for E. coli WP2 uvrA was set at 5000 ug/plate in both test systems.
Two-fold five serial dilutions were then prepared (6 concentrations each). Without metabolic activation, the mutagenicity of the S. typhimurium TA strains could not be examined due to growth inhibition, and therefore the mutagenicity test was repeated using the same concentrations.

Vehicle / solvent:

water for injection

Controls

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

benzo(a)pyrene

other: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide; 2-methoxy-6-chloro-9-[3-(2-chloroethyl) aminopropylamino] acridine.2HCl; 2-aminoanthracene

Details on test system and experimental conditions:

comparable to guideline

Evaluation criteria:

The result was assessed as positive when the number of revertant colonies in the test article group was particularly high (guide: double the number of revertant colonies in the negative control), and a concentration-response relationship and the reproducibility were observed.

Statistics:

No statistical analysis was conducted for assessment.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test item gave no indications for a mutagenicity potential in Salmonella typhimurium TA100, TA1535, TA98 and TA1537, and Escherichia coli WP2 uvrA.

Executive summary:

The mutagenicity potential of the test item was studied in Salmonella typhimurium TA100, TA1535, TA98 and TA1537, and Escherichia coli WP2 uvrA. The number of revertant colonies caused by the treatment with the test item was less than double the number of revertant colonies in the negative control, irrespective of metabolic activation. A dose-response relationship was not observed. Therefore it can be concluded that the test item gave no indications for a mutagenicity potential.