Reaction mass of disodium 7-amino-4-hydroxy-3-[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate and 7-amino-4-hydroxy-3-[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]azo]naphthalene-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:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1993

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

other: publicy available data

Title:

Salmonella: Study Summary

Author:

NTP

Year:

1993

Bibliographic source:

NTP

Materials and methods

Test guideline

Guideline:

other: NTP protocol

Principles of method if other than guideline:

In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene. The number of colonies is usually counted after 2 days.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

similar substance 07

IUPAC Name:

similar substance 07

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Vehicle / solvent:

solvent used: water

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not determined

Test results 2

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not determined

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

The sample was tested for gene mutation in the genome of Salmonella typhimurium. Two strains were used, TA 98 and TA 100 - delegating different types of mutations. The sample was diluted with water. The experiments were performed with and without metabolic activation by rat and hamster liver. The sample was mutagenic to strain TA 98 and TA 100 with and without metabolic activation.

Executive summary:

The sample was tested for gene mutation in the genome of Salmonella typhimurium., in strains TA 98 and TA 100, with and without metabolic activation by rat and hamster liver. The sample was mutagenic to strain TA 98 and TA 100 with and without metabolic activation.

Similar substance 07 could be considered as not mutagenic.