1,4-Dioxane-2,5-dione, 3,6-dimethyl-, (3R,6R)-

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

supporting study

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:

publication

Title:

Primary mutagenicity screening of food additives currently used in Japan.

Author:

Ishidate M. Jr., Sofuni T., Yoshikawa K., Hayashi M., Nohmi T., Sawada M., Matsuoka A.

Year:

1984

Bibliographic source:

Food Chem. Toxic. 22: 623-636

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Lactic acid

EC Number:

200-018-0

EC Name:

Lactic acid

Cas Number:

50-21-5

Molecular formula:

C3H6O3

IUPAC Name:

2-hydroxypropanoic acid

Method

Target gene:

Histidine locus

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

rat liver homogenate S9

Test concentrations with justification for top dose:

10 mg/plate, resp 1.0 mg/mL (Ames test)

Vehicle / solvent:

water: phosphate buffer (Ames test)

Controls

Untreated negative controls:

yes

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 2

Species / strain:

S. typhimurium, other: TA92, TA94, TA2637

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions reported, lactic acid did not cause gene mutations. Therefore, the test item is considered to be non-mutagenic in the bacterial reverse gene mutation assay.

Executive summary:

In a reverse gene mutation assay in bacteria, strains TA92, TA1535, TA100, TA1537, TA94, TA98 and TA2637 of S. typhimurium were exposed to 242 food additives including lactic acid. S. typhimurium strains were exposed to lactic acid at concentrations of 10 mg/plate (equivalent to 1.0 mg/mL) in the presence and absence of mammalian metabolic activation. There was no evidence of induced mutant colonies and cytotoxicity with and without metabolic activation. Therefore, the test item is considered to be non-mutagenic in this bacterial reverse gene mutation assay.