2-(2-methoxyethoxy)ethyl 4-[(5-cyano-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxopyridin-3-yl)azo]benzoate

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:

12 - 21 Jun 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

no E. Coli or S typhimurium TA 102 was used

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according 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:

2-phenoxyethyl 4-((5-cyano-1,6-dihydro-2-hydroxy-1,4-dimethyl-6-oxo-3-pyridinyl)azo)benzoate

EC Number:

414-260-1

EC Name:

2-phenoxyethyl 4-((5-cyano-1,6-dihydro-2-hydroxy-1,4-dimethyl-6-oxo-3-pyridinyl)azo)benzoate

Cas Number:

88938-37-8

Molecular formula:

C23H20N4O5

IUPAC Name:

2-phenoxyethyl 4-[2-(5-cyano-2-hydroxy-1,4-dimethyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]benzoate

Test material form:

solid: particulate/powder

Method

Target gene:

uvrB

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:

S9-Mix rat and hamster

Test concentrations with justification for top dose:

Concentration range in the main test (with and without metabolic activation): 8, 40, 200, 1000, 5000 µg/plate

Vehicle / solvent:

Solvent: EtOH

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

congo red

other: Sodium azide; Nitrofurantoin; 4-nitro-1,2-phenylendiamine; 2-aminoanthracene; benzidine

Results and discussion

Test results

Species / strain:

other: TA 1535, TA 100, TA 1537, TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

starting from >= 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene increased mutant counts to well over those of the negative controls, and thus demonstrated the system's sensitivity and the activity of the S9 mix.

Remarks on result:

other: plate incorporation method

Any other information on results incl. tables

Substance precipiation occurring from >= 1000 µg/plate

Applicant's summary and conclusion

Conclusions:

The test item was found to be non mutagenic in an OECD 471 neither in presence nor in absence of a metabolic activation system. The Prival modification assay proved the results of the plate incorporation method. Hence, the test item is considered non mutagenic in bacteria.

Executive summary:

The Salmonella/microsome test, modified according to Prival and Mitchell and employing doses up to 5000 µg per tube, showed the test item not to produce bacteriotoxic effects. Substance precipitation occurred from 1000 µg per tube and above.In agreement with the plate incorporation assay, evaluation of individual dose groups of the preincubation assay according to Prival and Mitchell, with respect to relevant assessment parameters (dose effect, reproducibility), revealed no biologically relevant variations from the respective negative controls. The test item was found to be non mutagenic in an OECD 471 neither in presence nor in absence of a metabolic activation system.