3-hydroxy-2-naphthoic acid

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to test guideline OECD 471 with acceptable restrictions but without GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

without confirmation of negative results

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-2-naphthoic acid

EC Number:

202-180-8

EC Name:

3-hydroxy-2-naphthoic acid

Cas Number:

92-70-6

Molecular formula:

C11H8O3

IUPAC Name:

3-hydroxynaphthalene-2-carboxylic acid

Details on test material:

- Name of test material (as cited in study report): 2-Hydroxynaphthalin-3-carbonsäure

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

liver S9 mix from male Sprague Dawley rats treated with Aroclor 1254 for enzyme induction.

Test concentrations with justification for top dose:

0, 4, 20, 100, 500, 1,000 µg/plate

Vehicle / solvent:

DMSO (dimethylsulphoxide)

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide, 9-aminoacridine, 2-nitrofluorene, MNNG, aminoanthracene, benzo(a)pyrene

Evaluation criteria:

Significant increase in the number of colonies compared to vehicle control. Dose dependent increase in the number of colonies.

Statistics:

not stated

Results and discussion

Test results

Test results 1

Species / strain:

other: S. typhimurium TA 1535, TA 1538, TA 98 and TA 100, and E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 500 - 10000 µg/plate (thinning of the bacterial lawn and reduction in the number of colonies)

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

A small increase in number of colonies in the absence of metabolic activation in the first experiment was not considered to represent genotoxicity (see Conclusions).

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 500 - 10000 µg/plate (thinning of the bacterial lawn and reduction in the number of colonies)

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 with and without metabolic activation

The test substance did not induce any relevant increase in the number of revertant colonies in the absence or presence of S9 mix. A small increase in number of revertant colonies in the absence of metabolic activation in S. typhimurium strain TA 1537 was attributed to a very low spontaneous rate of colonies in the vehicle control group, thus not representing genotoxicity. In addition, genotoxicity was not confirmed in the respective independent repeat experiment.

Executive summary:

3-Hydroxy-2-naphthoic acid was tested for mutagenicity in an Ames test equivalent to OECD Guideline 471 (Bacterial Reverse Mutation Assay) utilising S. typhimurium (TA 1535, TA 1537, TA 1538, TA 98 and TA 100) and E. coli WP2 uvrA (up to 1000 μg/plate) with and without metabolic activation.

In a pre-test, cytotoxicity was attained at concentrations of 500 to 10000 µg/plate. The test substance was not considered to be genotoxic in this study, as it did not induce any relevant increase in the number of revertant colonies in the absence or presence of S9 mix. A small increase in number of revertant colonies in the absence of metabolic activation in strain TA 1537 was not reproducible and was attributed to a very low spontaneous rate of colonies in the vehicle control group, thus not representing genotoxicity. In addition, genotoxicity was not confirmed in the respective independent repeat experiment.