Reaction product of acid red 143 (free acid) or the respective sodium salt (e.g Lansyn red F-5B) (UVCB) with Tetrabutylammonium bromide (CAS nr.: 1643-19-2) resulting in a mixture of AR143-(TBN)2 (Main component), AR143-(TBN), AR143-(TBN)3, AR143-(TBN) without alkyl tail, AR143-(TBN)2 without alkyl tail.Chemical name main component AR143-(TBN)2:di-(tetra-n-butylammonium) salt of 1-benzoyl-4-[4'-(1'',1''-dimethylpropyl)-phenoxy]-6-phenylamino-2,7-dioxo-2,7-dihydro-3H-naphtho(1,2,3-de)quinolin, disulfonic acid

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:

30/08/2006 - 18/09/2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

OECD Guidelines for Testing of Chemicals: Guideline no. 471: "Genetic Toxicology: Bacterial Reverse Mutation Test" (Adopted July 21, 1997)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

European Economic Community (EEC). Directive 2000/32/EC, Part B: Methods for the Determination of Toxicity; B.13/14: "Mutagenecity: "Reverse Mutation Test using bacteria". EEC Publication Commission Directive (Published June 8, 2000)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

1

Reference substance name:

-

EC Number:

473-100-9

EC Name:

-

Test material form:

solid: particulate/powder

Details on test material:

- Description: dark purple powder
- Solubility in the water: <= 0.412 g/L
- Melting point: > 250 °C
- Boiling point: > 250 °C
- Explosion: not explosion
- Log Pow: >= 3.3
- Test substance storage: at room temperature in the dark, 20°C, dry store
- Stability under storage conditions: stable

Specific details on test material used for the study:

Stability at higher temperature: Maximum temperature 75°C, maximum duration 48 hours
Stability in vehicle: Dimethyl sulfoxide: At least 96 hours
Solubility in vehicle: Dimethyl sulfoxide: Yes

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

TA1537 and TA98 are capable of detecting frameshift mutagens
TA1535 and TA100 are capable of detecting base-pair substitution mutagens (ref. 1, 2, 3, 4 and 5)

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Details on mammalian cell type (if applicable):

capable of detecting base-pair substitution mutagens (ref. 1, 2, 3, 4 and 5)

Vehicle / solvent:

dimethyl sulfoxide

Controls

Untreated negative controls:

yes

Remarks:

The vehicle of the substance, being dimethyl sulfoxide

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

2-nitrofluorene

sodium azide

methylmethanesulfonate

Details on test system and experimental conditions:

Test system: Salmonella typhimurium bacteria and Escherichia coli bacteria
Test substance preparation: The test substance was dissolved in dimethyl sulfoxide of spectroscopic quality (Uvasol, Merck, Darmstadt, Germany). Test substance concentrations were used within 4 hours after preparation.

Rationale for test conditions:

Recommended test system in international guidelines (e.g. OECD and EEC)

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

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

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

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

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

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

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

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

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

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

Applicant's summary and conclusion

Conclusions:

not mutagenic under the conditions of this test

Executive summary:

All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of relevants in independently repeated experiments.

The negative and strain-specific positve control values wer within our 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 SXjul2006 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.