Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts

EC Number:

291-454-0

EC Name:

Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts

Cas Number:

90411-76-0

Molecular formula:

Mixture of components, no definitve molecular formula existing.

IUPAC Name:

Complex mixture of phenazine dyes - IUPAC name not available

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

black powder
content 80.7 %

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9-mix was made from the livers of at least 5 adult male Sprague-Dawley rats . For enzyme induction the animals received a single intraperitoneal injection of Aroclor 1254 dissolved in corn oil five days prior to sacrifice

Test concentrations with justification for top dose:

with and without S9-mix:
50, 160, 500, 1600, 5000 µg/plate

Vehicle / solvent:

deionized water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

cumene hydroperoxide

mitomycin C

other: 4-nitro-1,2-phenylend diamine; 2-aminoanthracene

Details on test system and experimental conditions:

2 independent trials :
according to preincubation methodology or according to plate incorporation methodology

Evaluation criteria:

A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA1535, TA100, TA1537, TA98 this increase should be about twice that of negative controls. For TA102 an increase of about 100 mutants should be reached.
Otherwise the result is evaluated as negative

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

Nigrosin was initially investigated in the Ames test according to OECD TG 471 and GLP using the Salmonella typhimurium TA 98, TA100, TA102, TA1535, TA1537 and concentrations up to and including 5000 µg/plate.Bacteriotoxicity was not reached. None of the 5 strains used showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls neither in the presence nor in the absence of the metabolic activation system S9 -mix. The positve controls were functional.

Due to these results Nigrosin WLF has to be regarded as non-mutagenic in the Ames test .