C.I. Solvent Red 119

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2017 - October 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

C.I. Solvent Red 119

EC Number:

602-676-8

Cas Number:

12237-27-3

Molecular formula:

C32H22N10O8Cr

IUPAC Name:

C.I. Solvent Red 119

impurity 1

Reference substance name:

Unknown impurities

Cas Number:

not available

IUPAC Name:

Unknown impurities

impurity 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

solid: particulate/powder

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 97a

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:

The test item Solvent Red 119 showed no increase in the number of revertants in all bacteria
strains in both experiments.
Nearly all negative (one exception in the second experiment) and all strain-specific positive
control values were within the laboratory historical control data ranges indicating that the
test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that Solvent Red 119 is not mutagenic in
the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the
absence and presence of metabolic activation under the experimental conditions in the
present study.

In all experiments, no precipitation of the test item Solvent Red 119 was observed at any
of the tested concentrations up to 5000 μg/plate.
In the both experiments, the test item caused no cytotoxicity towards all bacteria strains
The confirmation tests of the genotype did not show any irregularities. The control of the
titre was above the demanded value of 109 bacteria/mL.
Nearly all of the means of all replicates of the spontaneous revertants (in negative and solvent
controls, one exception in the second experiment) were within the range of the historical
data of the test facility. All numbers of revertant colonies of the positive controls were
within the range of the historical data of the laboratory (historical data of the laboratory see
chapter 15, page 40) and were increased in comparison with the negative controls, which
demonstrated the mutagenic potential of the diagnostic mutagens.
Since all criteria for acceptability have been met, the study is considered valid.

Executive summary:

Two valid experiments were performed.

The study procedures described in this report were based on the most recent OECD and

EC guidelines.

The test item Solvent Red 119 was tested in the Salmonella typhimurium reverse mutation

assay with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and

TA1535).

The test was performed in two experiments in the presence and absence of metabolic

activation, with +S9 standing for presence of metabolic activation, and –S9 standing for

absence of metabolic activation.

In the first experiment, the test item (dissolved in DMSO) was tested up to concentrations

of 5000 μg/plate in the absence and presence of S9-mix in the strains TA97a, TA98,

TA100, TA102 and TA1535 using the plate incorporation method.

The test item showed no precipitates on the plates at any of the concentrations.

The bacterial background lawn was not reduced at any of the concentrations and no relevant

decrease in the number of revertants was observed in all bacteria strains. The test

item showed no signs of toxicity towards the bacteria strains in both the absence and

presence of metabolic activation.

The results of this experiment showed that none of the tested concentrations showed a

significant increase in the number of revertants in all tested strains, in the presence and

the absence of metabolic activation.

Based on the first experiment, the test item was tested up to concentrations of 5000

μg/plate in the absence and presence of S9-mix in all bacteria strains using the preincubation

method.

The test item showed no precipitates on the plates at any of the concentrations.

The bacterial background lawn was not reduced at any of the concentrations and no relevant

decrease in the number of revertants was observed in all bacteria strains. The test

item showed no signs of toxicity towards the bacteria strains in both the absence and

presence of metabolic activation.

The results of this experiment showed that the test item caused no increase in the number

of revertants in all bacteria strains compared to the solvent control, in both the absence

and presence of metabolic activation. The test item did not induce a dose-related increase

in the number of revertants colonies in all strains, in the presence and absence of metabolic

activation.

Based on the results of this study it is concluded that Solvent Red 119 is not mutagenic

in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and

TA1535 in the absence and presence of metabolic activation under the experimental

conditions in this study.