7-amino-4-hydroxynaphthalene-2-sulphonic 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:

data from handbook or collection of data

Justification for type of information:

Data is from handbook or collection of data

Data source

Reference

Reference Type:

publication

Title:

Genetic toxicity study in vitro for test substance

Author:

National Institute of Technology and Evaluation

Year:

2018

Bibliographic source:

Japan chemicals collaborative knowledge database (J-check), 2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

To evaluate the mutagenic potential of test chemical in S. typhimurium TA100, TA1535, TA98, TA1537, E. coli WP2 uvrA by AMES test.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

7-amino-4-hydroxynaphthalene-2-sulphonic acid

EC Number:

201-718-9

EC Name:

7-amino-4-hydroxynaphthalene-2-sulphonic acid

Cas Number:

87-02-5

Molecular formula:

C10H9NO4S

IUPAC Name:

7-amino-4-hydroxynaphthalene-2-sulfonic acid

Specific details on test material used for the study:

Histidine for Salmonella typhimurium and tryptophan Escherichia coli

Method

Target gene:

Histidine for Salmonella typhimurium and tryptophan Escherichia coli

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

not specified

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:

0, 156, 313, 625, 1250, 2500, 5000µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: [none; DMSO
- Justification for choice of solvent/vehicle: The test substance is soluble in DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

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 and WP2 uvrA), Sodium azide(TA1535), 9-Aminoacridine hydrochloride (TA1537) +S9 mix; 2-Aminoanthracene(all strains)

Details on test system and experimental conditions:

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

OTHER EXAMINATIONS: 3 plates per test were observed.

Evaluation criteria:

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

Statistics:

Yes, SD ± Mean was observed.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

bacteria, other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 2

Key result

Species / strain:

bacteria, other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: No mutagenic effects were observed.

Applicant's summary and conclusion

Conclusions:

Test chemical 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 absence of metabolic activation S9 while mutagenic effect were observed in all strain in the presence of metabolic activation.

Executive summary:

Genetic toxicity in vitro study was assessed for test chemical. For this purpose AMES test was performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan).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 and absence of metabolic activation were 156, 313, 625, 1250, 2500 and 5000 µg/plate. The test result was considered to be negative in all strain in the absence of metabolic activation S9 while mutagenic effect were observed in all strain in the presence of metabolic activation.