Sodium 2-amino-4,6-dinitrophenoxide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary literature.

Data source

Reference

Reference Type:

secondary source

Title:

OPINION on test chemical

Author:

European Commission

Year:

2011

Bibliographic source:

Directorate-General for Health & Consumers; Scientific Committee on Consumer Safety SCCS

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Principles of method if other than guideline:

To evaluate the mutagenic potential of test chemical in mouse lymphoma L5178Y cells by In mammalian cell gene mutation assay.

GLP compliance:

not specified

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-amino-4,6-dinitrophenoxide

EC Number:

212-603-8

EC Name:

Sodium 2-amino-4,6-dinitrophenoxide

Cas Number:

831-52-7

Molecular formula:

C6H5N3O5.Na

IUPAC Name:

sodium 2-amino-4,6-dinitrophenoxide

Method

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Additional strain / cell type characteristics:

other: tk+/-

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

experiment 1: 112.5, 225, 450, 900, 1350 and 1800 μg/ml with and without S9-mix
experiment 2: 28.1, 56.3, 112.5, 225, 337.5 and 450 μg/ml without S9-mix
112.5, 225, 450, 750, 900, 1050 and 1200 μg/ml with S9-mix

Vehicle / solvent:

de-ionised water

Controls

Controls 1

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

cyclophosphamide

Controls 2

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Details on test system and experimental conditions:

Treatment experiment 1: 4h treatment with and without S9-mix
experiment 2: 4h treatment with and 24h without S9-mix

Evaluation criteria:

The cells were evaluated for mutagenic potential.

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions reported, the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation.

Executive summary:

Test substance was assessed for its possible mutagenic potential. For this purpose In vitro Mammalian cell gene mutation assay was performed as per OECD 476 in Mouse Lymphoma cell line L5178Y. The test material was exposed at the concentration mention below.

experiment 1: 112.5, 225, 450, 900, 1350 and 1800 μg/ml with and without S9-mix

experiment 2: 28.1, 56.3, 112.5, 225, 337.5 and 450 μg/ml without S9-mix

                         112.5, 225, 450, 750, 900, 1050 and 1200 μg/ml with S9-mix

 

 

No substantial and reproducible concentration-dependent increase in mutant colony numbers was observed in both main experiments. No relevant shift of the ratio of small versus large colonies was observed up to the maximal concentration of the test item. Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies, indicating that the tests were sensitive and valid. The concentration range of the main experiments was adjusted to toxicity data and the occurrence of precipitation. Therefore test substance was considered to be non-mutagenic in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay. Hence the substance cannot be classified as gene mutant in vitro.