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

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

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

Specific details on test material used for the study:

Histidine for Salmonella typhimurium and tryptophan Escherichia coli

Target gene:

Histidine for Salmonella typhimurium and tryptophan Escherichia coli

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

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.

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

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.

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.

Reference 2

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

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 from handbook or collection of data

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Principles of method if other than guideline:

To evaluate the mutagenic potential of test chemical in Chinese hamster lung(CHL)cells by in vitro mammalian chromosome aberration test.

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

Target gene:

Not specified

Species / strain / cell type:

other: Chinese hamster lung(CHL)cells

Details on mammalian cell type (if applicable):

- Type and identity of media: Chinese hamster lung derived fibroblast cell line (CHL).

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(24hr continuous exposure): 0, 375, 750, 1500 µg/mL
-S9 mix(48hr continuous exposure): 0, 375, 750, 1500 µg/mL
-S9 mix(short-term exposure): 0, 375, 750, 1500µg/mL
+S9 mix(short-term exposure): 0, 375, 750, 1500 µg/mL

Vehicle / solvent:

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

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, Mitomycin C +S9 mix, Cyclophosphamide

Details on test system and experimental conditions:

Details on test system and conditions
Cells were seeded on a multi-plate for cell culture, and the test substance solution was treated 3 days after the culture. In the case of the continuous treatment method, the treatment is carried out continuously for 24 or 48 hours, and in the short treatment method, after treatment for 6 hours in the presence of S9 mix (+ S 9 mix) or absence (-S 9 mix), fresh The medium was replaced with a culture medium, and the culture was continued for 18 hours.
After fixation of the cells with 10% neutral buffered formalin solution (Wako Pure Chemical Industries, Ltd.), the cells were stained with 0.1% crystal violet (Kanto Kagaku Co., Ltd.) aqueous solution for 10 minutes. An appropriate amount of pigment eluate (30% ethanol, 1% acetic acid aqueous solution) was added and allowed to stand for about 5 minutes to elute the dye, and the absorbance at 580 nm was measured. For each dose group, the ratio to the absorbance in the solvent control group, ie the cell viability was calculated.

SPINDLE INHIBITOR (cytogenetic assays): colcemid
NUMBER OF CELLS EVALUATED: 100 cells were evaluated.

OTHER EXAMINATIONS:
- Determination of polyploidy: Yes

Evaluation criteria:

The cells were observed for chromosomal gaps, chromatid breaks (ctb), chromosome breaks (csb), chromosome segments (csb), chromosome segments They were classified as structural anomalies of exchange (cte), chromosome exchange (cse) and others (oth). At the same time, the incidence of ploidy cells was recorded.

Species / strain:

other: CHL/IU cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: No mutagenic effect were observed

Conclusions:

Test chemical was evaluated for its mutagenic potential in chemical in Chinese hamster lung (CHL)cells by in vitro mammalian chromosome aberration test. The test result was considered to be negative both in the presence and absence of metabolic activation

Executive summary:

Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian chromosome aberration test was performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan).The test material was exposed to Chinese hamster lung (CHL)cells in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were mention below

-S9 mix(24hr continuous exposure): 0, 375, 750, 1500 µg/mL

-S9 mix(48hr continuous exposure): 0, 375, 750, 1500 µg/mL

-S9 mix(short-term exposure): 0, 375, 750, 1500µg/mL

+S9 mix(short-term exposure): 0, 375, 750, 1500 µg/mL

 No chromosomal abbreviation, gaps were observed in cells, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic in Chinese hamster lung (CHL)cells by in vitro mammalian chromosome aberration test. Hence the substance cannot be classified as gene mutant in vitro.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Data for the various publication were observed for test chemical. Test chemical was reviewed to determine the mutagenic nature of 7-amino-4-hydroxynaphthalene-2-sulphonic acid (87-02-5). The studies are as mentioned below:

Ames assay

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.

In vitro Mammalian chromosome aberration study

Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian chromosome aberration test was performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan).The test material was exposed to Chinese hamster lung (CHL)cells in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were mention below

-S9 mix(24hr continuous exposure): 0, 375, 750, 1500 µg/mL

-S9 mix(48hr continuous exposure): 0, 375, 750, 1500 µg/mL

-S9 mix(short-term exposure): 0, 375, 750, 1500µg/mL

+S9 mix(short-term exposure): 0, 375, 750, 1500 µg/mL

 No chromosomal abbreviation, gaps were observed in cells, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic in Chinese hamster lung (CHL) cells by in vitro mammalian chromosome aberration test. Hence the substance cannot be classified as gene mutant in vitro.

The confirmatory test, In vitro Mammalian chromosome aberration assay reflects non mutagenic nature of the test substance. Thus based on this data the test substance cannot be classified as mutagenic in vitro. Therefore the substance is non mutagenic in nature.

Justification for classification or non-classification

Thus based on the above annotation and CLP criteria, test substance 7-amino-4-hydroxynaphthalene-2-sulphonic acid (87-02-5) did not induce gene mutation .Hence it is not likely to be mutagenic in vitro.