Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex

Genetic toxicity: in vitro

Administrative data

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:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity Testing of Certified Food Colors and Related Azo, Xanthene And Triphenylmethane Dyes with the Salmonella/Microsome System

Author:

Joseph P. Brown, Gerald W. Roehm and Ronald J. Brown

Year:

1978

Bibliographic source:

Mutation Research, 56 (1978) 249-271

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mention below

Principles of method if other than guideline:

To evaluate the Genotoxic effect of Sunset Yellow in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate

EC Number:

220-491-7

EC Name:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate

Cas Number:

2783-94-0

Molecular formula:

C16H12N2O7S2.2Na

IUPAC Name:

disodium (5E)-6-oxo-5-[(4-sulfonatophenyl)hydrazinylidene]naphthalene-2-sulfonate

Test material form:

solid

Details on test material:

- Name of test material: disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Molecular formula: C16H12N2O7S2.2Na
- Molecular weight: 454.38
- Substance type: organic
- Physical state: solid
-Purity : 91%

Specific details on test material used for the study:

- Name of test material (as cited in study report):sunset yellow
- Molecular formula (if other than submission substance):C16H12N2O7S2.2Na
- Molecular weight (if other than submission substance):452.37 g/mol
- Substance type;Organic
- Physical state:solid
-Purity;91%

Method

Target gene:

no data

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA1535, TA100, TA1537, TA1538, and TA98.

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

The mammalian liver homogenate fraction "S-9" was prepared from female Sprague Dawley rats were injected i.p. with about 0.5 ml of a corn oil solution of Aroclor 1254

Test concentrations with justification for top dose:

50 and 250 µg/plate

Vehicle / solvent:

Vehicle
- Vehicle(s)/solvent(s) used: water or DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Ethylmethanesulfonate (5 µl) Methylmethanesulfonate (1 µl) 9-Aminoaeridine (50µl) Nitroquinoline-N-oxide (0.22 pg) Anthragallol ( 50 µ g ) 2-Anthramine (1 µg) Negative control Dithionite

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period:16 hour
- Exposure duration:3 days
- Expression time (cells in growth medium): 3days

OTHER: Liquid test was also performed .

Rationale for test conditions:

Not specified

Evaluation criteria:

The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls.

Statistics:

Mean was observed.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA1535, TA100, TA1537, TA1538, and TA98.

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: No mutagenic effect were observed

Any other information on results incl. tables

SCREENING OF CERTIFIED FOOD COLORS AND RELATED COMPOUNDS WITH THE SALMONELLA/MICROSOME TEST SYSTEM; AZO DERIVATIVES TESTED BEFORE AND AFTER CHEMICAL REDUCTION TO COMPONENTAMINES- by plate method         Number of His + r e v e r t a n t s / p l a t e Test compound µg^b Chemical c Microsome d reduction activation ( d i t h i o n i t e ) Microsome reduction activation ( d i t h i o n i t e ) ($9) TA 1535 TA 100 TA1537 TA1538 TA98 Control - - - 31 + 22 (203) 94 +_ 25 (205 8 -+ 5 (222) 12 -+ 5 (222) 36 -+ 21 (207       20-+21(183) 87-+24(192) 12-+5(208) 12-+5(208) 28 _+ 15 (233) FD and C YeHow No. 6 50 - _ 62 110 16 17 23   + 13 75 13 28 29 250 - _ 69 98 9 9 28   + 19 89 18 43 44         a Compounds tested that are considered to be mutagenic (+) or probably mutagenic (?+). b Chemical reduction of azo compounds with Na2S204 immediately prior to plating. c Activation with "S-9 mix" rat liver micro some preparations from animals induced with Aroclor 1254. d Tester strains exhibiting a mutagenic response on treatment with the test agent: 5, TA1535; 0, TA100; 7, TA1537, 8, TA1538; 9, TA98. e Estimated revertants/nmol test agent for strain showing greatest activity (in parentheses). f Mutagenic response in terms of h/s + r e v e r t a n t s / p l a t e less control for indicated exposure in ~g, also for strain in parentheses. * Separate experiment with TA98 only. t Activity with TA100 obtained with ATP (ca. 3.5 mg/ml liquid test mixture). * Aerobic liquid test.

Applicant's summary and conclusion

Conclusions:

The result was considered to be negative (with and without) for Sunset Yellow(2783-94-0) in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.

Executive summary:

Genotoxic study was observed for Sunset Yellow in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.The Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 were exposed at the concentration of 50 and 250µg /plate with and without S9. The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. The azo dye Yellow No.6 was plated in the usual fashion at concentrations from 50 pg/plate to 500 pg/plate and then were incubated anaerobically for 16 h before the usual 3-day aerobic incubation. All results with the five tester strains with and without microsomal activation were negative. Therefore the result was considered to be negative (with and without) for Sunset Yellow in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method. Hence the substance cannot be classified as gene mutant in vitro.