6-aminonaphthalene-1,3-disulphonic acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Experimental study for target was conducted by R. Jung, D.et al (Food and chemical toxicology, 1992) to determine the mutagenic nature. Mutagenicity of substance Naphthalene-1,3-disulfonic acid, 6-amino- was assessed by using Ames test. It shows negative mutagenic result. The substance Naphthalene-1,3-disulfonic acid, 6-amino-is considered to be not mutagenic in Salmonella typhimurium. Hence it cannot be classified as gene mutant in vitro.

 Supported by an experimental study for target ,which was conducted by European Chemicals Bureau (IUCLID dataset, European Chemicals Bureau, 2000) to determine the mutagenic nature. Mutagenicity of substance 6-aminonaphthalene-1,3-disulfonic acid was assessed by using Ames test. The test material was exposed to Salmonella typhimurium strain TA 1535, TA 100, TA 1537, TA 98in the presence and absence of metabolic activation. It shows negative mutagenic result. The substance6-aminonaphthalene-1,3-disulfonic acid is considered to be not mutagenic in Salmonella typhimurium strain TA 1535, TA 100, TA 1537, TA 98.Hence it cannot be classified as gene mutant in vitro.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from publication.

Qualifier:

according to guideline

Guideline:

other: As mention below

Principles of method if other than guideline:

Mutagenicity of substance Naphthalene-1, 3-disulfonic acid, 6-amino- was assessed by using Ames test.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

- Name of test material:6 amino-1,3 naphthalene –disulfonic acid
- Molecular formula: C10H9NO6S2
- Molecular weight: 303.314 g/mole
- Smiles notation: c12c(cc(S(O)(=O)=O)cc1S(O)(=O)=O)cc(N)cc2
- InChl: 1S/C10H9NO6S2/c11-7-1-2-9-6(3-7)4-8(18(12,13)14)5-10(9)19(15,16)17/h1-5H,11H2,(H,12,13,14)(H,15,16,17)
- Substance type: Organic
- Physical state: Solid

Species / strain / cell type:

S. typhimurium, other:

Details on mammalian cell type (if applicable):

Not applicable.

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

Not specified.

Metabolic activation:

not specified

Test concentrations with justification for top dose:

Not specified.

Vehicle / solvent:

Not specified.

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Details on test system and experimental conditions:

Not specified.

Rationale for test conditions:

Not specified.

Evaluation criteria:

Not specified.

Statistics:

Not specified.

Key result

Species / strain:

S. typhimurium, other: Not specified

Metabolic activation:

not specified

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Conclusions:

The substance Naphthalene-1,3-disulfonic acid, 6-amino- is considered to be not mutagenic in Salmonella typhimurium.

Executive summary:

Mutagenicity of substance Naphthalene-1,3-disulfonic acid, 6-amino- was assessed by using Ames test.It shows negative mutagenic result. The substance Naphthalene-1,3-disulfonic acid, 6-amino-is considered to be not mutagenic in Salmonella typhimurium. Hence it can not 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

Genotoxicity In-vitro

Various publications were reviewed to determine the mutagenic nature of 6-aminonaphthalene-1,3-disulfonic acid (118-33-2). The studies are as mentioned below:

Experimental study for target was conducted by R. Jung, D.et al (Food and chemical toxicology, 1992) to determine the mutagenic nature. Mutagenicity of substance Naphthalene-1,3-disulfonic acid, 6-amino- was assessed by using Ames test. It shows negative mutagenic result. The substance Naphthalene-1,3-disulfonic acid, 6-amino-is considered to be not mutagenic in Salmonella typhimurium. Hence it cannot be classified as gene mutant in vitro.

 Supported by an experimental study for target ,which was conducted by European Chemicals Bureau (IUCLID dataset, European Chemicals Bureau, 2000) to determine the mutagenic nature. Mutagenicity of substance 6-aminonaphthalene-1,3-disulfonic acid was assessed by using Ames test. The test material was exposed to Salmonella typhimurium strain TA 1535, TA 100, TA 1537, TA 98in the presence and absence of metabolic activation. It shows negative mutagenic result. The substance6-aminonaphthalene-1,3-disulfonic acid is considered to be not mutagenic in Salmonella typhimurium strain TA 1535, TA 100, TA 1537, TA 98.Hence it cannot be classified as gene mutant in vitro.

 In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by F. RAFII et al.( Food and Chemical Toxicology,1997) to determine the mutagenic nature of D&C Red No. 33 (RA CAS No3567-66-6; IUPAC name: disodium 5-amino-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate. The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. In a gene toxicity test, Salmonella typhimurium Strain-TA 98, TA 100 were exposed to D&C Red No. 33 in the concentration of 50 and 200 µg/plate with and without metabolic activation. In addition D&C Red No. 33 metabolites were also prepared by treating with azo reductase -producing bacteria namely Clostridium strain isolated from the human gastrointestinal tract. The results showed that there was no evidence of gene toxicity after treatment with D&C Red No. 33 in the concentration of 50 and 200 µg/plate in Salmonella typhimurium Strain-TA 98, TA 100. Independently of tested D&C Red No. 33 reduced metabolite in the concentration of 50 and 200 µg/plate showed that there was no evidence of gene toxicity. Therefore, it is considered that D&C Red No. 33 and its reduced metabolites in the concentration of 50 and 200 µg/plate do not cause genetic mutation(s) when Salmonella typhimurium Strain-TA 98, TA 100 exposed to the test chemical in the presence and absence of metabolic activation (S9).

 

In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by National Institute of Technology and Evaluation (Japan chemicals collaborative knowledge database, 2017) to determine the mutagenic nature of Sodium 4-aminonaphthalene-1-sulfonate (130-13-2). The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. Gene toxicity in vitro study was observed for Sodium 4-aminonaphthalene-1-sulfonate (130-13-2) in Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA. The test substance was observed at the concentration of 313, 625, 1250, 2500, 5000 µg/plate in the presence and absence of metabolic activation. The test result was considered to be negative with and without metabolic activation. Therefore Sodium 4-aminonaphthalene-1-sulfonate was considered to be non mutant in vitro. Hence cannot be classified as genetox in vitro.

Based on the data available for the target chemical as well as its read across substance and applying weight of evidence 6-aminonaphthalene-1,3-disulfonic acid (118-33-2)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Thus based on above annotation and CLP criteria available for the target chemical and its read across substance 6-aminonaphthalene-1,3-disulfonic acid (118-33-2)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.