Methyl N-(2,6-dimethylphenyl)-DL-alaninate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from Jcheck.

Data source

Reference

Reference Type:

review article or handbook

Title:

Bacterial reverse mutation assy for Sodium 4-methylbenzenesulfonate

Author:

National Institute of Technology and Evaluation

Year:

2017

Bibliographic source:

Japan chemicals collaborative knowledge database (J-check), 2017.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Guidelines for Screening Mutagenicity Testing of Chemicals(Japan) and OECD Guideline No. 471 and 472

Principles of method if other than guideline:

To evaluate the mutagenic potential of Dimethyl naphthalene-2,6-dicarboxylate in Salmonella typhimurium, TA100, TA1535, TA98, TA1537,Escherichia coli WP2 uvrA by Bacterial reverse mutation assay.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl naphthalene-2,6-dicarboxylate

EC Number:

212-661-4

EC Name:

Dimethyl naphthalene-2,6-dicarboxylate

Cas Number:

840-65-3

Molecular formula:

C14H12O4

IUPAC Name:

2,6-dimethyl naphthalene-2,6-dicarboxylate

Specific details on test material used for the study:

Details on test material
- Name of test material (as cited in study report): Dimethyl naphthalene-2,6-dicarboxylate
- Molecular formula: C14H12O4
- Molecular weight: 244.25 g/mol
- Substance type: Organic
- Purity; : 99.9 %

Method

Target gene:

Histidine for Salmonella typhimurium and tryptophan Escherichia coli

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA100, TA1535, TA98, TA1537,Escherichia coli WP2 uvrA

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

Rat liver, induced with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

-S9 mix; 0, 313, 625, 1250, 2500, 5000µg/plate (five strains)
+S9 mix; 0, 313 - 5000µg/plate (five strains)

Vehicle / solvent:

Vehicle
- Vehicle(s)/solvent(s) used: water

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: -S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide(TA100, TA98, WP2uvrA) , Sodium azide(TA1535) and 9-Aminoacridine(TA1537) +S9 mix; 2-Aminoanthracene(all strains)

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: Preincubation method
NUMBER OF REPLICATIONS: Duplicate

OTHER EXAMINATIONS: 3 plates per test were observed.

Rationale for test conditions:

Not specified

Evaluation criteria:

Evaluation was done considering a dose dependent increase in the number of revertants/plate.

Statistics:

Not specified.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA100, TA1535, TA98, TA1537,Escherichia coli WP2 uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

Additional information on results
ADDITIONAL INFORMATION ON CYTOTOXICITY: No cytotoxicity was not observed at 5000µg/plate in all strains with or without S9 mix.

Remarks on result:

other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:

Dimethyl naphthalene-2,6-dicarboxylate (840-65-3)was evaluated for its mutagenic potential in Salmonella typhimurium, TA100, TA1535, TA98, TA1537,Escherichia coli WP2 uvrA by AMES test. The test result was considered to be negative in all strain in the presence and absence of metabolic activation S9.

Executive summary:

Genetic toxicity in vitro study was assessed for Dimethyl naphthalene-2,6-dicarboxylate . For this purpose AMES test was performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan) and OECD Guideline No. 471 and 472.The test material was exposed to Salmonella typhimurium, TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA in the presence and absence of metabolic activation S9. The concentration of test material used in the presence of metabolic activation were 0, 313 - 5000µg/plate. While in the absence of metabolic activation the concentration were 0, 313, 625, 1250, 2500, 5000µg/plate. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore Dimethyl naphthalene-2,6-dicarboxylate was considered to be non mutagenic in Salmonella typhimurium, TA100, TA1535, TA98, TA1537,Escherichia coli WP2 uvrA by AMES test. Hence the substance cannot be classified as gene mutant in vitro.