3-hydroxy-2'-methoxy-2-naphthanilide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25.11.-18.12.1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-2'-methoxy-2-naphthanilide

EC Number:

205-206-6

EC Name:

3-hydroxy-2'-methoxy-2-naphthanilide

Cas Number:

135-62-6

Molecular formula:

C18H14NNaO3

IUPAC Name:

3-hydroxy-2'-methoxy-2-naphthanilide

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:

S. typhimurium TA 1538

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254(R) induced rat liver S9-mix

Test concentrations with justification for top dose:

Experiment I: 0, 4 to 10 000 µg/plate (6 doses)
Experiment II: 0, 0.16, 0.8, 4, 20, 50, 100, 250 µg/plate (6 doses)

Vehicle / solvent:

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

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

without metabolic activation; no further specifications were given

Details on test system and experimental conditions:

Two independent experiments were performed

Evaluation criteria:

negative result: no significant and no dose dependant increase in the number of revertant colonies

Statistics:

Arithmetic means of the counted colonies were calculated.

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:

cytotoxicity

Remarks:

at 50 or 100 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 50 or 100 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 50 or 100 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test item did not exert mutagenic activity in the Salmonella typhimurium and Escherichia coli reverse mutation assay with and without metabolic activation.

Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhymurium strains TA1535, TA1537, TA98, TA100 and TA1538 as well as Escherichia coli WP2 uvrA with and without metabolic activation (induced rat liver S9-mix) at concentrations of 0 to 10 000 µg/plate in the first experiment and up to 2500 µg/plate in the second experiment.

Under the conditions tested the test compound did not cause a significant increase in the number of revertant colonies in any strain and no dose dependent effect was observed with or without metabolic activation.

The test substance proved to be toxic at doses at 50 or 100 µg/plate.

Therefore the test item is not considered mutagenic under the conditions of test in this bacterial reverse mutation assay.