L-Threonine, N-coco acyl derivs., monosodium 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:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Version / remarks:

In accordance with the guideline set forth in the "Standards for Mutagenicity Tests using Microorganisms" (Notification No. 77, September 1, 1988 & Notification No. 67, June 2, 1997, Ministry of Labour, Japan) and the "Amendment of the Reporting Form of the Results of the Mutagenicity Tests using Microorganisms" (Notification No. 653, September 29, 1997, Labour Standards Bureau, Ministry of Labour, Japan), and the "Guidelines for Toxicity Testings of New Chemical Substances" (Notification No. 1121002 of Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 2 of the Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, & No. 031121002 of Environmental Policy Bureau, Ministry of the Environment, Japan, November 21, 2003). And it was conducted in compliance with the "Standards to be observed by Mutagenicity Testing Institutions" (Notification No. 76, September 1, 1988 & Notification No. 13, March 29, 2000, Ministry of Labour, Japan) and the "GLP Standards for the Test Facility on New Chemical Substances" (Notification No. 1121003 of Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 3 of Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, & No. 031121004 of Environmental Policy Bureau, Ministry of the Environment, Japan, November 21, 2003).

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

L-Threonine, N-coco acyl derivs., monosodium salts

Cas Number:

90583-79-2

Molecular formula:

n/a

IUPAC Name:

L-Threonine, N-coco acyl derivs., monosodium salts

Test material form:

solid

Specific details on test material used for the study:

Name: Sodium Cocoyl Threoninate
BML-CODE: BML-10672
Lot No.: TCS-070717-3
Purity: 98% (w/w)
Impurities: Water (2% w/w)

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:

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
Doses were based on a dose-finding study.

Vehicle / solvent:

water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

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:

According to guideline

Evaluation criteria:

In the dose-finding test and the main tests, if the number of revertant colonies an the test plates increased significantly in comparison with that an the control plates (based on twice as many as that of the negative control), and dose-response and reproducibility were also observed, the test substance was to be judged positive.

Statistics:

Statistical analysis was not done.

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Sodium Cocoyl Threoninate was not mutagenic under the described study conditions.

Executive summary:

The mutagenic potential of Sodium Cocoyl Threoninate was assessed with Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 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, it is judged that Sodium Cocoyl Threoninate was not mutagenic under the described study conditions.